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Ventilación no invasiva con presión positiva (PPCVR o VNIPP a dos niveles) para el edema pulmonar cardiogénico

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References

References to studies included in this review

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Agmy 2008 {published and unpublished data}

Agmy G. The effect of CPAP and NPPV on acute pulmonary edema due to systolic diastolic or valvular heart failure [Abstract]. European Respiratory Journal 2007;30(Suppl 51):321.
Agmy G, Makhlouf H, Mohammed A, Ghanem M, Mohammed H. CPAP versus BiPAP in acute cardiogenic pulmonary edema experience with 129 patients [Abstract]. European Respiratory Society Annual Congress 2008;8:1937.
Agmy GM. The effect of CPAP and NPPV on acute cardiogenic pulmonary edema due to systolic, diastolic or valvular heart failure [Abstract]. American Thoracic Society International Conference 2007;1:A963.

Bautin 2005 {published and unpublished data}

Bautin A, Khubulava G, Naumov A, Garifzjanov A, Etin V. NPPV in the treatment of the cardiogenic edema (CPE) after heart surgery [Abstract]. European Respiratory Journal 2005;26(Suppl 49):3112.

Bellone 2004 {published data only}

Bellone A, Monari A, Cortellaro F, Vetorello M, Arlati S, Coen D. Myocardial infarction rate in acute pulmonary edema: noninvasive support ventilation versus continuous positive airway pressure. Critical Care Medicine 2004;32(9):1860‐5.

Bellone 2005 {published data only}

Bellone A, Vettorello M, Monari A, Cortellaro F, Coen D. Noninvasive pressure support ventilation vs. continuous positive airway pressure in acute hypercapnic pulmonary edema. Intensive Care Medicine 2005;31:807‐11.

Bersten 1991 {published and unpublished data}

Bersten AD, Holt AW, Vedig AE, Skowronski GA, Bagooley CJ. Treatment of severe cardiogenic pulmonary edema with continuous positive airway pressure delivered by face mask. New England Journal of Medicine 1991;325(26):1825‐30.

Crane 2004 {published and unpublished data}

Crane SD, Elliott MW, Gilligan P, Richards K, Gray AJ. Randomized controlled comparison of continuous positive airway pressure, bilevel non‐invasive ventilation, and standard treatment in emergency department patients with acute cardiogenic pulmonary oedema. Emergency Medicine Journal 2004;21:155‐61.

Delclaux 2000 {published data only}

Delclaux C, L'Her E, Alberti C, Mancebo J, Abroug F, Conti G, et al. Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivery by a face mask. JAMA 2000;284:2352‐60.

Ferrari 2007 {published data only}

Ferrari G, Olliveri F, De Filippi G, Milan A, Apra F, Boccuzzi A, et al. Noninvasive positive airway pressure and risk of myocardial infarction in acute cardiogenic pulmonary edema: continuous positive airway pressure vs noninvasive positive pressure ventilation. Chest 2007;132(6):1804‐9.

Ferrari 2010 {published data only}

Ferrari G, Groff P, De Filippi G, Giostra F, Mazzone M, Potale G, et al. Continuous positive airway pressure (CPAP) vs. noninvasive positive pressure ventilation (NIV) in acute cardiogenic pulmonary edema (ACPE): A prospective randomized multicentric study. Journal of Emergency Medicine 2006;30:246‐7.
Ferrari G, Milan A, Groff P, Pagnozzi F, Mazzone M, Molino P, et al. Continuous positive airway pressure vs. Pressure support ventilation in acute cardiogenic pulmonary edema: a randomized trial. Journal of Emergency Medicine 2010;39(5):676‐84.

Ferrer 2003 {published data only}

Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A. Non‐vasive Ventilation in Severe Acute Hypoxemic Respiratory Failure. A Randomized Clinical Trial. Intensive Care Medicine 2002;28:S68.
Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A. Noninvasive Ventilation in Severe Hypoxemic Respiratory Failure: A Randomized Clinical Trial. American Journal of Respiratory and Critical Care Medicin 2003;168:1438‐44.

Fontanella 2010 {published data only}

Bordonali T, Fontanella B, Affatato A, Saporetti A, Carubelli V, Ciccarese C, et al. Comparison of continuous positive airway pressure (CPAP) versus bilevel non invasive pressure support ventilation (NIPSV) in acute cardiogenic pulmonary edema. European Heart Journal 2009;30:369. [EMBASE: 797]
Fontanella B, Affatato A, Ciccarese C, Sacchini M, Volpini M, Bianchetti F, et al. Prospective comparison of continuous positive airway pressure (CPAP) versus bilevel non invasive pressure support ventilation (BPAP) in acute cardiogenic pulmonary edema. European Heart Journal Supplements 2010;12 (supplement F):F37‐F38.

Frontin 2010 {published data only}

Frontin P, Bounes V, Houzé‐Cerfon CH, Charpentier S, Houzé‐Cerfon V, Ducassé JL. Continuous positive airway pressure for cardiogenic pulmonary edema: a randomized study. American Journal of Emergency Medicine 2011;29(7):775‐81.

Gray 2008 {published data only}

Gray A, Goodacre S, Newby DE, Masson M, Sampson F, Nicholl J. Noninvasive Ventilation in AcuteCardiogenic Pulmonary Edema. New England Journal of Medicine 2008;359:142‐51.
Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S, et al. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non‐invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technology Assessment 2009;13(33):1‐106.

Kelly 2002 {published and unpublished data}

Kelly CA, Newby DE, McDonagh TA, MacKay TW, Barr J, Boon NA, et al. Randomised controlled trial of continuous positive airway pressure and standard oxygen therapy in acute pulmonary oedema. European Heart Journal 2002;23:1379‐86.

L'Her 2004 {published data only}

L'Her E, Duquesne F, Girou E, Rosiere XD, Le Conte P, Renault S, et al. Noninvasive continuous positive airway pressure in elderly cardiogenic pulmonary edema patients. Intensive Care Medicine 2004;30:882‐8.

Levitt 2001 {published data only}

Levitt MA. A prospective, randomized trial of BiPAP in severe acute congestive heart failure. Journal of Emergency Medicine 2001;21(4):363‐9.

Liesching 2003 {published data only}

Liesching TN, Cromier K, Nelson D, Short K, Sucov A, Hill NS. Bilevel noninvasive ventilation vs continuous positive airway pressure to treat acute pulmonary edema. American Journal of Respiratory and Critical Care Medicine 2003;167(Suppl 7):27.

Lin 1991 {published data only}

Lin M, Chiang H. The efficacy of early continuous positive airway pressure therapy in patients with acute cardiogenic pulmonary edema. Journal of the Formosan Medical Association 1991;90(8):736‐43.

Lin 1995 {published data only}

Lin M, Yang Y, Chiang H, Chang M, Chiang BN, Cheitlin MD. Reappraisal of continuous positive airway pressure therapy in acute cardiogenic pulmonary edema. Chest 1995;107:1379‐86.

Martin‐Bermudez 2002 {published and unpublished data}

Martin‐Bermudez R, Rodrı´guez‐Portal J, Garcı´a‐Garmendia J. Noninvasiveventilation in cardiogenic pulmonay edema. Preliminary results of a randomizedtrial [Abstract]. Intensive Care Medicine 2002;28:S68.

Masip 2000 {published data only}

Masip J, Betbesé AJ, Paéz J, Vecilla F, Cañizares R, Padró J, et al. Non‐invasive pressure support ventilation versus conventional oxygen therapy in acute cardiogenic pulmonary oedema: a randomized trial. Lancet 2000;356:2126‐32.

Mehta 1997 {published data only}

Mehta S, Jay GD, Woolard RH, Hipona RA, Connolly EM, Cimini DM, et al. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Critical Care Medicine 1997;25(4):620‐8.

Moritz 2007 {published data only}

Moritz F, Brousse B, Gellee B, Chajara A, L'Her E, Hellot MF, et al. Continuous positive airway pressure versus bilevel noninvasive ventilation in acute cardiogenic pulmonary edema: a randomized multicenter trial. Annals of Emergency Medicine 2007;50(6):666‐75.

Nava 2003 {published and unpublished data}

Carbone G, Di Battista N, Nava S. Noninvasive bilevel ventilation vs conventional therapy in the treatment of acute cardiogenic pulmonary edema: a randomized controlled study. European Respiratory Journal 2000;16:A3815.
Nava S. Bilevel ventilation reduces the rate of endotracheal intubation in the hypercapnic, but not in the hypoxemic patients during acute respiratory failure due to cardiogenic pulmonary edema: a multicenter randomized study vs standard medical therapy. European Respiratory Journal 2001;18:A184s.
Nava S, Carbone G, DiBattista N, Bellone A, Baiardi P, Cosentini R, et al. Noninvasive ventilation in cardiogenic pulmonary edema. American Journal of Respiratory and Critical Care Medicine 2003;168:1432‐7.

Park 2001 {published and unpublished data}

Park M. Randomized prospective trial of oxygen, continuos and bilevel positive airway pressure in the treatment of cardiogenic acute pulmonary edema. American Journal of Respiratory and Critical Care Medicine 2002;165(Suppl 8):A27.
Park M, Lorenzi‐Filho G, Feltrim MI, Viecili PRN, Sangean MC, Volpe M, et al. Oxygen therapy, continuous positive airway pressure, or noninvasive bilivel positive pressure ventilation in the treatment of acute cardiogenic pulmonary edema. Arquivos Brasileiros de Cardiologia 2001;76(3):226‐30.

Park 2004 {published and unpublished data}

Park M, Sangean MC, Volpe MS, Feltrim MIZ, Nozawa E, Leite PF, et al. Randomized, prospective trial of oxygen, continuous positive airway pressure by face mask in acute cardiogenic pulmonary edema. Critical Care Medicine 2004;32(12):2407‐15.

Räsänen 1985 {published data only}

Räsänen J, Heikkilä J, Downs J, Nikki P, Väisänen I, Viitanen A. Continuous positive airway pressure by face mask in acute cardiogenic pulmonary edema. American Journal of Cardiology 1985;55:296‐300.

Sharon 2000 {published data only}

Sharon A, Shpirer I, Kaluski E, Moshkovitz Y, Milanov O, Polak R, et al. High‐dose intravenous Isosorbide‐dinitrate is safer and better than Bi‐PAP ventilation for severe pulmonary edema. Journal of the American College of Cardiology 2000;36(3):832‐7.

Takeda 1997 {published and unpublished data}

Takeda S, Takano T, Ogawa R. The effect of nasal continuous positive airway pressure on plasma endothelin‐1 concentrations in patients with severe cardiogenic pulmonary edema. Anesthesia & Analgesia 1997;84:1091‐6.

Takeda 1998 {published and unpublished data}

Takeda S, Neijima J, Takano T, Nakanishi K, Takayama M, Sakamoto A, et al. Effect of nasal continuous positive airway pressure on pulmonary edema complicating acute myocardial infarction. Circulation Journal 1998.;62:553‐8.

Thys 2002 {published and unpublished data}

Thys F, Roeseler J, Reynaert M, Liistro G, Rodenstein DO. Noninvasive ventilation for acute respiratory failure: a prospective randomised placebo‐controlled trial. European Respiratory Journal 2002;20:545‐55.

Weitz 2007 {published and unpublished data}

Weitz G, Struck J, Zonak A, Balnus S, Perras B, Dodt C. Prehospital noninvasive pressure support ventilation for acute cardiogenic pulmonary edema. European Journal of Emergency Medicine 2007;14(5):276‐9.

References to studies excluded from this review

Jump to:

Acosta 2000 {published data only}

Acosta B, DiBenedetto R, Rahimi A, Acosta MF, Cuadra O, Van Nguyen A, et al. Hemodynamic effects of noninvasive bilevel positive airway pressure on patients with chronic congestive heart failure with systolic dysfunction. Chest 2000;118(4):1004‐9.

Albert 2000 {published data only}

Albert RK. Turnabout may be more than fair play. Critical Care Medicine 2000;28(2):571‐2.

Alper 2007 {published data only}

Alper BS. Evidence‐based medicine. Noninvasive ventilation reduces mortality in cardiogenic pulmonary edema. Clinical Advisor for Nurse Practitioners 2007;10(5):158.

Alper 2008 {published data only}

Alper BS. Evidence‐based medicine. Noninvasive ventilation may improve respiratory distress in acute heart failure. Clinical Advisor for Nurse Practitioners 2008;11(11):118.

Andrade 1998 {published data only}

Andrade CLV, Mendoza JN. Acute respiratory distress of the adult [Distress respiratorio agudo del adulto]. Boletín del Hospital San Juan de Dios 1998;45(1):13‐9.

Antonelli 2001 {published data only}

Antonelli M, Conti G, Moro ML, Esquinas A, Gonzalez‐Diaz G, Confalonieri M, et al. Predictors of failure of noninvasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: A multi‐center study. Intensive Care Medicine 2001;27(11):1718‐28.

Aronow 2007 {published data only}

Aronow WS. Heart‐Failure‐Complicating Acute Myocardial Infarction. Clinics in Geriatric Medicine 2007;23(1):123‐39.

Barach 1938 {published data only}

Barach AL Martin J, Eckman M. Positive pressure respiration and its application to the treatment of acute pulmonary edema. Annals of Internal Medicine 1938;12:754‐95.

Baratz 1992 {published data only}

Baratz DM, Westbrook PR, Shah PK, Mohsenifar Z. Effect of nasal continuous positive airway pressure on cardiac output and oaxygen delivery in patients with congestive heart failure. Chest 1992;102(5):1397‐401.

Bavry 2008 {published data only}

Bavry AA. Effect of continuous positive airway pressure and noninvasive positive pressure ventilation in acute cardiogenic pulmonary oedema (3CPO). ACC Cardiosource Review Journal 2008;17(9):37.

Bellone 2002 {published data only}

Bellone A, Barbieri A, Ricci C, Iori E, Donateo M, Massobrio M, et al. Acute effects of non‐invasive ventilatory support on functional mitral regurgitation in patients with exacerbation of congestive heart failure. Intensive Care Medicine 2002;28(9):1348‐50.

Blomqvist 1991 {published data only}

Blomqvist H. Does PEEP facilitate the resolution of extravascular lung water after experimental hydrostatic pulmonary edema?. European Respiratory Journal 1991;4:1053‐9.

Bollaert 2002 {published data only}

Bollaert PE, Sauder PH, Girard F, Rusterholtz TH, Feissel M, Harlay ML, et al. Continuous positive airway pressure (CPAP) VS proportional assist ventilation (PAV) for noninvasive ventilation in cardiogenic pulmonary edema. American Journal of Respiratory and Critical Care Medicine. 2002; Vol. 165, issue Suppl 8:A387.

Bouquin 1998 {published data only}

Bouquin V, L'Her E, Moriconi M, Jobic Y, Matheu B, Guillo P, et al. Spontaneous ventilation in positive expiratory pressure in cardiogenic pulmonary edema. Archives des maladies du Coeur et des Vaisseaux 1998;91(10):1243‐8.

Bradley 2000 {published data only}

Bradley TD. continuous positive airway pressure for congestive heart failure. Canadian Medical Association Journal 2000;162(4):535‐6.

Brezins 1993 {published data only}

Brezins M, Benari B, Papo V, Cohen A, Bursztein S, Markiewicz W. Left ventricular function in patients with acute myocardial infarction, acute pulmonary edema, and mechanical ventilation: Relationship to prognosis. Critical Care Medicine 1993;21(3):380‐5.

Brijker 1999 {published data only}

Brijker F, van den Elshout FJ, de Rijk A, Folgering HT, Bosch FH. Use of noninvasive mechanical ventilation to avoid intubation during acute respiratory insufficiency. Nederlands Tijdschrift voor Geneeskunde 1999;143(36):1819‐23.

Brochard 1998 {published data only}

Brochard L. Use of non‐invasive positive pressure ventilation for cardiogenic pulmonary edema in emergency care unit. Presse Medicale 1998;27(22):1105‐7.

Chadda 2002 {published data only}

Chadda K, Annane D, Hart N, Gajdos P, Raphael JC, Lofaso F. Cardiac and respiratory effects of continuous positive airway pressure and noninvasive ventilation in acute cardiac pulmonary edema. Critical Care Medicine 2002;30(11):2457‐61.

Chen 2008 {published data only}

Chen Y, Chen P, Hanaoka M, Huang X, Droma Y, Kubo K. Mechanical ventilation in patients with hypoxemia due to refractory heart failure. Internal Medicine 2008;47(5):367‐73.

Crane 2002 {published data only}

Crane SD. Epidemiology, treatment and outcome of acidotic, acute, cardiogenic pulmonary oedema presenting to and Emergency department. European Journal of Emergency Medicine 2002;9:320‐4.

Craven 2000 {published data only}

Craven RA, Singletary N, Bosken L, Sewell E, Payne M, Lipsey R. Use of bilevel positive airway pressure in out‐of‐hospital patients. Academic Emergency Medicine 2000;7(9):1065‐8.

Cross 2000 {published data only}

Cross AM. Review of the role of non‐invasive ventilation in the emergency department. Journal of Accident & Emergency Medicine 2000;17(2):79‐85.

Cross 2003 {published data only}

Cross AM, Cameron P, Kierce M, Ragg M, Kelly AM. Non‐invasive ventilation in acute respiratory failure: a randomized comparison of continuous positive airway pressure and bi‐level positive airway pressure. Emergency Medicine Journal 2003;20(6):531‐4.

Cydulka 2005 {published data only}

Cydulka RK. Noninvasive ventilation in cardiogenic pulmonary edema: A multicenter randomized trial. Annals of Emergency Medicine 2005;45(2):227‐8.

Domenighetti 2002 {published data only}

Domenighetti G, Gayer R, Gentilini R. Noninvasive pressure support ventilation in non‐COPD patients with acute cardiogenic pulmonary edema and severe community‐acquired pneumonia: acute effects and outcome. Intensive Care Medicine 2002;28(9):1226‐32.

Du Cailar 1975 {published data only}

Du Cailar J, Huguenard P, Kielen J, Griffe D. Justification, methods and indications for positive‐pressure respiration in controlled and spontaneous ventilation in lesional pulmonary edeman. Annales de l'Anesthesiologie Francaise 1975;2:196‐206.

Eaton 2002 {published data only}

Eaton S. Martin G. Clinical developments for treating ARDS. Expert Opinion on Investigational Drugs 2002;11(1):37‐48.

Evans 2001 {published data only}

Evans TW, Albert RK, Angus DC, Bion JF, Chiche J, Epstein SK, et al. International Consensus conferences in intensive care medicine: noninvasive positive pressure ventilation in acute respiratory failure. American Journal of Respiratory and Critical Care Medicine 2001;163:283‐91.

Fromm 1995 {published data only}

Fromm Jr RE, Varon J, Gibbs LR. Congestive heart failure and pulmonary edema for emergency physician. Journal of Emergency Medicine 1995;13(1):71‐87.

Giacomini 2003 {published data only}

Giacomini M, Iapichino G, Cigada M, Minuto A, Facchini R, Noto A, et al. Short‐term noninvasive pressure support ventilation prevents ICU admittance in patients with acute cardiogenic pulmonary edema. Chest 2003;123(6):2057‐61.

Girou 2003 {published data only}

Girou E, Brun‐Buisson C, Taille S, Lemaire F, Brochard L. Secular trends in nosocomial infections and mortality associated with noninvasive ventilation in patients with exacerbation of COPD and pulmonary edema. JAMA 2003;290(22):2985‐91.

Gorbunova 2005 {published data only}

Gorbunova M, Babak S, Tatrskiy A. Effect of nasal continuous positive airway pressure on respiratory failure and left ventricular dysfunction complicating acute myocardial infarction [Abstract]. European Respiratory Journal 2005;26(Suppl 49):1.

Gray 2009 {published data only}

Gray AJ, Goodacre S, Newby DE, Masson MA, Sampson F, Dixon S. A multicentre randomised controlled trial of the use of continuous positive airway pressure and non‐invasive positive pressure ventilation in the early treatment of patients presenting to the emergency department with severe acute cardiogenic pulmonary oedema: the 3CPO trial. Health Technology Assessment 2009;13(33):1‐106.

Guerra 2005 {published data only}

Guerra JF. Noninvasive ventilation in acute cardiogenic pulmonary edema [Ventilación no invasiva en el edema pulmonar agudo cardiogénico: debe individualizarse?]. Medicina Clínica 2005;124(4):142‐3.

Guntupalli 1984 {published data only}

Guntupalli KK. Acute pulmomnary edema. Cardiology Clinics 1984;2(2):183‐200.

Gust 1998 {published data only}

Gust R, Bohrer H. Changes in crdiac output do not explain the higher rate of myocardial infarction associated with the use of bilevel compared with continuous positive airway pressure. Critical Care Medicine 1998;26(2):415‐6.

Hao 2002 {published data only}

Hao CX, Luo XR, Liu YM. Treatment of severe cardiogenic pulmonary edema with continuous positive airway pressure by nasal face mask. Acta Academiae Medicinae Jiangxi 2002;42(5):48‐50.

Hess 2004 {published data only}

Hess DR. The evidence for noninvasive positive‐pressure ventilation in the care of patients in acute respiratory failure: a systematic review of the literature. Respiratory Care 2004;49(7):810‐29.

Hilberg 1997 {published data only}

Hilberg RE, Johnson DC. Noninvasive ventilation. New England Journal of Medicine 1997;337(34):1746‐52.

Hipona 1996 {published data only}

Hipona RA, Jay GD, Woolard RH, Hill NS, Mehta S. Positive airway pressure suppor and myocardial ischemia. Academic Emergency Medicine 1996;3(7):729‐30.

Hoffman B 1999 {published data only}

Hoffmann B. Welte F. The use of noninvasive pressure support ventilation for severe respiratory insufficiency due to pulmonary oedema. Pneumologie 1999;53(6):316‐21.

Hoffmann 1999 {published data only}

Hoffmann B. Welte T. The use of noninvasive pressure support ventilation for severe respiratory insufficiency due to pulmonary oedema. Intensive Care Medicine 1999;25(1):15‐20.

Holt 1994 {published data only}

Holt AW, Bersten AD, Fuller S, Piper RK, Worthley LI, Vedig AE. Intensive care costing methodology: cost benefit analysis of mask continuous positive airway pressure for severe cardiogenic pulmonary oedema. Anaesthesia and Intensive Care 1994;22(2):170‐4.

Hotchkiss 1998 {published data only}

Hotchkiss JR, Marini JJ. Noninvasive ventilation: An emerging supportive technique for the emergency department. Annals of Emergency Medicine 1998;32(4):470‐9.

Hubble 2006 {published data only}

Hubble MW, Richards ME, Jarvis R, Millikan T, Young D. Effectiveness of prehospital continuous positive airway pressure in the management of acute pulmonary edema. Prehospital Emergency Care 2006;10(4):430‐9.

Hughes 1999 {published data only}

Hughes CM. Review: continuous positive airway pressure support reduces the need for intubation in patients with cardiogenic pulmonary edema. ACP Journal Club 1999;130(3):58.

Iapichino 2004 {published data only}

Iapichino G, Giacomini M, Bassi G, Borotto E, Minuto A. Non invasive mechanical ventilation in acute cardiogenic pulmonary edema: is it all done?. Minerva Anestesiologica 2004;70(4):151‐7.

Jackson 2000 {published data only}

Jackson P. Continuous positive airway pressure: the need for prehospital research and clinical trials. Australasian Journal of Emergency Care 2000;7(3):22‐5.

Jackson 2001 {published data only}

Jackson R, Carley S. CPAP in acute left ventricular failure. Emergency Medicine Journal 2001;18(1):63‐4.

Jackson R 2001 {published data only}

Jackson R, Jones S. NIPPV for acute cardiogenic pulmonary oedema. Emergency Medicine Journal 2001;18(6):464‐5.

Kallio 2003 {published data only}

Kallio T, Kuisma M, Alaspaa A, Rosenberg PH. The use of prehospital continuous positive airway pressure treatment in presumed acute severe pulmonary edema. Prehospital Emergency Care 2003;7(2):209‐13.

Keenan 2004 {published data only}

Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Critical Care Medicine 2004;32(12):2516‐23.

Kelly 2001 {published data only}

Kelly C, Newby DE, Boon NA, Douglas NJ. Support ventilation versus conventional oxygen. Lancet 2001;357:1126.

Kiely 1998 {published data only}

Kiely JL, Deegan P, Buckley A, Shiels P, Maurer B, McNicholas WT. Efficacy of nasal continuous positive airway pressure therapy in chronic heart failure: Importance of underlying cardiac rhythm. Thorax 1998;53(11):957‐62.

Kindgen‐Milles 2000 {published data only}

Kindgen‐Milles D, Buhl R, Gabriel A, Bohner H, Muller E. Nasal continuous positive airway pressure: A method to avoid endothracheal reintubation in postoperative high‐risk patients with severe nonhypercapnic oxygenation failure. Chest 2000;117(4):1106‐11.

Kosowsky 2000 {published data only}

Kosowsky JM, Storrow AB, Carleton SC. Continuous and bilevel positive airway pressure in the treatment of acute cardiogenic pulmonary edema. American Journal of Emergency Medicine 2000;18(1):91‐5.

Kosowsky 2001 {published data only}

Kosowsky JM, Stephanides SL, Branson RD, Sayre MR. Prehospital use of continuous positive airway pressure (CPAP) for presumed pulmonary edema: a preliminary case series. Prehospital Emergency Care 2001;5(2):190‐6.

Kramer 1995 {published data only}

Kramer N, Thomaas JM, Meharg J, Cece RD, Hill NS. Randomized, prospective trial of noninvasive positive pressure ventilation in acute respiratory failure. American Journal of Respiratory and Critical Care Medicine 1995;151:1799‐806.

L'Her 1998 {published data only}

L'Her E, Duquesne F, Paris A, Mouline J, Renault A, Garo B, Boles JM. Spontaneous positive end‐expiratory pressure ventilation in elderly patients with cardiogenic pulmonary edema. Presse Medicale 1998;27(22):1089‐94.

L'Her E 1998 {published data only}

L'Her E, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non‐invasive continuous positive airway pressure in acute hypoxaemic respiratory failure‐‐experience of an emergency department. European Journal of Emergency Medicine 1998;5(3):313‐8.

Lal 1969 {published data only}

Lal S, Savidge RS, Chhabra GP. Oxygen administration after myocardial infarction. Lancet 1969;1:381‐3.

Lapinsky 1994 {published data only}

Lapinsky SE, Mount DB, Mackey D, Grossman RF. Management of acute respiratory failure due to pulmonary edema with nasal positive pressure support. Chest 1994;105:229‐31.

Leman 2005 {published data only}

Leman P, Greene S, Whelan K, Legassick T. Simple lightweight disposable continuous positive airways pressure mask to effectively treat acute pulmonary oedema: randomized controlled trial. Emergency Medicine Australasia 2005;17(3):224‐30.

Lenique 1997 {published data only}

Lenique F, Habis M, Lofaso F, Dubois‐Randé J, Harf A, Brochard L. Ventilatory and hemodynamic effects of continuous positive airway pressure in left heart failure. American Journal of Respiratory and Critical Care Medicine 1997;155:500‐5.

Li 2004 {published data only}

Li XK, Zhao WH. The treatment of acute cardiogenic pulmonary edema with noninvasive positive pressure ventilation. Chongqing Medical Journal 2004;34(4):575‐6.

Liesching T 2003 {published data only}

Liesching T. Kwok H. Hill NS. Acute applications of noninvasive positive pressure ventilation. Chest 2003;124(2):699‐713.

Lo Coco 1997 {published data only}

Lo Coco A, Vitali G, Marchese S, Bozzo P, Pesco C, Arena A. Treatment of acute respiratory failure secondary to pulmonary oedema with bi‐level positive airway pressure by nasal mask. Monaldi Archives For Chest Disease 1997;52(5):444‐6.

Mackay CA 2000 {published data only}

Mackay CA, Mackay TW, Barr J, Newby D, McDonagh T, Douglas NJ. Randomized controlled trial of CPAP vs conventional therapy in acute pulmonary edema. American Journal Respiratory Critical Care Medicine 2000;161:A416.

Masip 2008 {published data only}

Masip J, Mebazaa A, Filippatos GS. Noninvasive ventilation in acute cardiogenic pulmonary edema. New England Journal of Medicine 2008;359(19):2068‐9.

Massaria 1976 {published data only}

Massaria E, De Liguori S, Castelli P, Cattani C, Merli M, Pratelli EM. Use of artificial respiration in complicated acute myocarial infarct. Critical evaluation. Minerva Anestesiologica 1976;42(5):391‐5.

Meduri 1991 {published data only}

Meduri GU. Nonivasive face mask mechanical ventilation in patients with acute hipercapnic respiratory failure. Chest 1991;100:445‐54.

Mehta 2000 {published data only}

Mehta S, Liu PP, Fitzgerald FS, Allidina YK, Douglas Bradley T. Effects of continuous positive airway pressure on cardiac volumes in patients with ischemic and dilated cardiomyopathy. American Journal of Respiratory and Critical Care Medicine 2000;161(1):128‐34.

Mehta 2004 {published data only}

Mehta S. Continuous versus bilevel positive airway pressure in acute cardiogenic pulmonary oedema? A good question!. Critical Care Medicine 2004;32(12):2546‐8.

Mehta 2005 {published data only}

Mehta S, Nava S. Mask ventilation and cardiogenic pulmonary edema: "another brick in the wall". Intensive Care Med 2005;31:757‐9.

Minuto 2003 {published data only}

Minuto A, Giacomini M, Giamundo B, Tartufari A, Denkewitz T, Marzorati S, et al. Non‐invasive mechanical ventilation in patients with acute cardiogenic pulmonary edema. Minerva Anestesiologica 2003;69(11):835‐40.

Mollica 2001 {published data only}

Mollica C, Brunetti G, Buscajoni M, Cecchini L, Maialetti E, Marazzi M, et al. Non‐invasive pressure support ventilation in acute hypoxemic (non hypercapnic) respiratory failure. Observations in Respiratory Intermediate Intensive Care Unit. Minerva Anestesiologica 2001;67(3):107‐15.

Moritz 2003 {published data only}

Moritz F, Benichou J, Vanhest M, Richard JC, Line S, Hellot MF, et al. Boussignac continuous positive airway pressure device in the emergency care of acute cardiogenic pulmonary oedema: a randomized pilot study. European Journal of Emergency Medicine 2003;10(3):204‐8.

Murray 2002 {published data only}

Murray S. Bi‐level positive airway pressure (BiPAP) and acute cardiogenic pulmonary oedema (ACPO) in the emergency department. Australian Critical Care 2002;15(2):51‐63.

Murray 2003 {published data only}

Murray S. Bi‐level positive airway pressure (BiPAP) and acute cardiogenic pulmonary oedema (ACPO) in emergency department. Australian Emergency Nursing Journal 2003;6(1):19‐35.

Nadar 2005 {published data only}

Nadar S, Prasad N, Taylor RS, Lip GYH. Positive pressure ventilation in the management of acute and chronic cardiac failure: A systematic review and meta‐analysis. International Journal of Cardiology 2005;99(2):171‐85.

Nava 2002 {published data only}

Nava S, Carlucci A. Non‐invasive pressure support ventilation in acute hypoxemic respiratory failure: Common strategy for differnet pathologies?. Intensive Care Medicine 2002;28(9):1205‐7.

Newberry 1995 {published data only}

Newberry DL. Noninvasive bilevel positive pressure ventilation in severe acute pulmonary edema. American Journal of Emergency Medicine 1995;13:479‐82.

Newby 2007 {published data only}

Newby D. 3CPO. ACC Cardiosource Review Journal 2007;16(10):38‐43.

Nikki 1982 {published data only}

Nikki P, Rasanen J, Tahvanainen J, Makelainen A. Ventilatory pattern in respiratory failure arising from acute myocardial infarction. I. Respiratory and hemodynamic effects of IMV4 vs IPPV12 and PEEP0 vs PEEP10. Critical Care Medicine 1982;10(2):75‐8.

Niranjan 1998 {published data only}

Niranjan V, Bach J, Agusti AGN, Barbe F, Tagores B, Hilberg RE, Johnson DC. Noninvasive ventilation. New England Journal of Medicine 1998;338(19):1388‐9.

Panacek 2002 {published data only}

Panacek EA, Kirk JD. Role of noninvasive ventilation in the managemnet of acutely descompensated heart failure. Reviews i Cardiovascular Medicine 2002;3(Suppl 4):S35‐40.

Pang 1998 {published data only}

Pang D, Keena SP, Cook DJ, Sibald WJ. The effect of positive pressure airway support on mortality and the need for intubation i cardiogenic pulmonary edema: A systematic review. Chest 1998;114(4):1185‐92.

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Park M. Noninvasive ventilation in threatment of the acute pulmonary oedema. Where are we really?. Jornal do médico ‐ Hospital Sírio Libanês 2005;38:10‐1.

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Lorenzi‐Filho, Geraldo DB. Noninvasive mechanical ventilation in the treatment of acute cardiogenic pulmonary edema. Clinics 2006;61(3):247‐252.

Perel 1983 {published data only}

Perel A, Willianson DC. Effectiveness of CPAP by mask for pulmonary edema associated with hypercarbia. Intensive Care Medicine 1983;9:17‐9.

Perkins 2006 {published data only}

Perkins GD, McAuley DF, Thickett DR, Gao F. From the authors. American Journal of Respiratory and Critical Care Medicine 2006;173(11):1291‐Transcatheter valve implantation versus aortic valve replacement for aortic stenosis in high‐risk patients2.

Philip‐joet 1999 {published data only}

Philip‐Joet FF, Paganelli FFF, Dutau HL. Hemodynamic effects of bilevel nasal positive airway pressure ventilation in patients with heart failure. Respiration 1999;66:136‐43.

Plaisance 2007 {published data only}

Plaisance P, Pirracchio R, Berton C, Vicaut E, Payen D. A randomized study of out‐of‐hospital continuous positive airway pressure for acute cardiogenic pulmonary oedema. European Heart Journal 2007;28(23):2895‐901.

Pollack 1996 {published data only}

Pollack CV, Torres MT, Alexander L. Feasibility study of the use of bilevel positive airway pressure for respiratory support in the emergency department. Annals of Emergency Medicine 1996;27(2):189‐92.

Poponick 1999 {published data only}

Poponick JM, Renston JP, Bennett RP, Emerman CL. Use of a ventilatory support system (BIPAP) for acute respiratory failure in the emergency department. Chest 1999;116(1):166‐71.

Popova 2010 {published data only}

Popova X, Avdeev S, Nekludova G, Chuchalin A. Effect of noninvasive ventilation (NIV) on exercise tolerance in patients with acute decompensated heart failure [Abstract]. Europe Respiratory Society Conference. 2010:E3918.

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Poulton PE. Left‐side heart failure with pulmonary edema: its treatment with the "pulmonary plus pressure machine". Lancet 1936;2:981‐3.

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Rizk 1982 {published data only}

Rizk NW, Murray JF. PEEP and pulmonary edema. American Journal of Medicine 1982;72:381‐3.

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Rusterholtz 1999 {published data only}

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Rutherholtz 2008 {published data only}

Rusterholtz T, Bollaert PE, Feissel M, Romano‐Girard F, Harlay ML, Zaehringer M. Continuous positive airway pressure vs. proportional assist ventilation for noninvasive ventilation in acute cardiogenic pulmonary edema. Intensive Care Medicine 2008;34(5):840‐6.

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Sachetti A. Effectiveness of BiPAP for congestive heart failure. Journal of the American College of Cardiology 2001;37(6):1754‐5.

Sachetti 1995 {published data only}

Sachetti AD, Harris RH, Paston C. Bi‐level positive airway pressure support system use in acut congestive failure:Preliminary case series. Academic Emergency Medicine 1995;2:714‐8.

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Salvucci A. CPAP for cardiogenic pulmonary edema. Emergency Medical Services 2001;30(7):84.

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Sarullo FM, D'Alfonso G, Brusca I, De Michele P, Taomina A, Di Pasquale P, et al. Efficacy and safety of non‐invasive positive pressure ventilation therapy in acute pulmonary edema. Monaldi Archives for Chest Disease 2004;62(1):7‐11.

Schettino 2008 {published data only}

Schettino G, Altobelli N, Kacmarek RM. Noninvasive positive‐pressure ventilation in acute respiratory failure outside clinical trials: experience at the Massachusetts General Hospital. Critical Care Medicine 2008;36(2):441‐7.

Severinghaus 2002 {published data only}

Severinghaus JW. Sightings. High Altitude Medicine & Biology 2002;3(1):9‐16.

Simonds 2000 {published data only}

Simonds AK. Nasal ventilation: Where are we?. Monaldi Archives for Chest Disease 2000;55(1):45‐9.

Sinuff 2000 {published data only}

Sinuff T, Cook DJ, Randall J, Allen C. Noninvasive positive‐pressure ventilation: A utilization review of use in a teaching hospital. Canadian Medical Association Journal 2000;163(8):969‐73.

Somauroo 2000 {published data only}

Somauroo J, Wilkinson M, White V, Rodrigues E, Connolly D, Calverley P, et al. Acute hemodynamic changes of nasal bilevel and continuous positive airway pressure ventilation in patients with congestive heart failure. American Journal of Respiratory and Critical Care Medicine 2000;161(3):A548.

Sutton 2002 {published data only}

Sutton AGC, Cooper N, Jacob B. Biphasic positive pressure ventilation in acute cardiogenic pulmonary oedema. British Journal of Cardiology 2002;9(3):141‐2.

Trevisan 2008 {published data only}

Trevisan CE, Vieira SR. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: A randomized clinical trial. Critical Care 2008;12:2.

Uy 2003 {published data only}

Uy CA, Limpin MEB, Guzman AV, De Guia TS. Continuous positive airway pressure (CPAP) among patients with cardiogenic pulmonary edema. European Respiratory Journal 2003;22(Suppl 45):P553.

Uy 2004 {published data only}

Uy CA, Limpin MB, Guzman AV, De Guia TS. Continuous positive airway pressure amoung patients with cadiogenic pulmonary edema [Abstract]. American Thoracic Society 100th International Conference 2004;1:C23.

Vaisanen 1987 {published data only}

Vaisanen IT, Rasane J. Continuous positive airway pressure and supplemental oxygen in the treatment of cardiogenic pulmonary edema. Chest 1987;92(3):481‐5.

Valipour 2004 {published data only}

Valipour A, Cozzarini W, Burghuber OC. Non‐invasive pressure support ventilation in patients with respiratory failure due to severe acute cardiogenic pulmonary edema. Respiration 2004;71(2):144‐51.

Werdan 1999 {published data only}

Werdan K. Emergency treatment of acute heart failure. Deutsche Medizinische Wochenschrift 1999;124(Suppl 2):S54‐63.

Widger 2001 {published data only}

Widger HN, Hoffman P, Mazzolini D, Stone A, Scholly S, Clark J. Pressure upport noninvasive positive pressure ventilation treatment of acute cardiogenic pulmonary edema. American Journal of Emergency Medicine 2001;19(3):179‐81.

Wood 1998 {published data only}

Wood KA, Lewis L, Harz BV, Kollef MH. The use of noninvasive positive pressure ventilation in the emergency department. Chest 1998;113:1339‐46.

Wright 2001 {published data only}

Wright J, Louis J, Younge P, Crane SD, Gray AJ, Elliott MW. The role of non‐invasive ventilation in the emergency department. Emergency Medicine Journal 2001;18(5):413‐4.

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Wysocki M, Tric L, Wolff MA, Millet H, Herman B. Noninvasive pressure support ventilation in patients with acute respiratory failure. A randomized comparison with conventional therapy. Chest 1995;107(3):761‐8.

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Wysocki M. Noninvasive ventilation in acute cardiogenic pulmonary edema: Better than CPAP?. Intensive Care Medicine 1999;25:1‐2.

Zhang 2008 {published data only}

Zhang H‐Y, Li C‐S. Changes of plasma B‐type natriuretic peptide level during non‐invasive ventilation in treating acute left heart failure. Academiae Medicinae Sinicae 2008;30(2):140‐3.

NCT00554580 {published and unpublished data}

Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema. Ongoing study November 6, 2007.

NCT00912158 {published data only}

Noninvasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema. Ongoing study April 8, 2009.

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Confalonieri M, Potena A, Carbone G, Della Porta R, Tolley E, Meduri GU. Acute respiratory failure inpatients with severe community acquired pneumonia. A prospective randomized evaluation of non‐invasive ventilation. American Journal of Respiratory and Critical Care Medicine 1999;160:1585‐91.

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Gay PC. Complications of Noninvasive Ventilation in Acute Care. Respiratory Care 2009;54(2):246–57.

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Gibelin P. Acute cardiogenic pulmonary edema and its treatment. La Revue du Praticien 2002;52(15):1655‐8.

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Guimarães JI. Latin‐American guideline for the evaluation and management of descompensed heart failure. 2004 [I Diretriz Latino‐Americana para Avaliação e Conduta na Insuficiência Cardíaca Descompensada]. Available online at http://publicacoes.cardiol.br/consenso/2004/I_Dir_Latino_Americ_Ins_Cardiaca.asp (accessed 13 February 2005).

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Kelly 1997

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Peter J, V, Moran JL, Phillips‐Hughes J, Graham P, Bersten AD. Effect of non‐invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta‐analysis. Lancet 2006;367:1155‐63.

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Potts JM. Noninvasive positive pressure ventilation: effect on mortality in acute cardiogenic pulmonary edema: a pragmatic meta‐analysis. Polskie Archiwum Medycyny Wewnętrznej 2009;119(6):349‐52.

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Remme WJ, Cleland JGF, Dargie H, Erdmann R, Ferrari J, Kjekshus M, et al. The treatment of heart failure. The task force of the Working Group on heart failure of the European Society of Cardiology. European Heart Journal 1997;18:736‐53.

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Väisänen IT, Räsänen J. Continuous positive airway pressure and supplemental oxygen in threatment of cardiogenic pulmonary edema. Chest 1987;92(3):481‐5.

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Weng CL, Zhao YT, Liu QH, Fu CJ, Sun F, Ma YL, et al. Meta‐analysis: Noninvasive ventilation in acute cardiogenic pulmonary edema. Annals of Internal Medicine 2010;152(9):590‐600.

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References to other published versions of this review

Jump to:

Vital 2008

Vital FMR, Saconato H, Ladeira MT, Sen A, Hawkes CA, Soares B, Burns KEA, Atallah ÁN. Non‐invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema. Cochrane Database of Systematic Reviews 2008, Issue 3. [DOI: 10.1002/14651858.CD005351.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Jump to:

Agmy 2008

Methods

Single centre randomised controlled trial, parallel design, unblinded, using ITT approach. No patients were lost to follow up. Setting: RICU or CCU.

Participants

129 participants. Causes: systolic, diastolic or valvular heart failure.

Interventions

CPAP group. N=44.
BILEVEL group. N=44.
Control group: standard medical care+O2 mask (High flow facemask ‐ 60%). N= 41.
Co‐intervention: morphine, diuretics, ACE and nitrates.

Outcomes

  1. Mortality

  2. Need for tracheal intubation

  3. Arterial blood gases (PaO2, PaCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Length of hospital stay

  6. Length of ICU stay

  7. Intrapulmonary shunt

  8. A‐aoxygengradient

  9. Cardiac output

  10. Intolerance

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Bautin 2005

Methods

Randomised controlled trial, parallel design, unblinded, using ITT approach. No patients were lost to follow up. Setting: ICU.

Participants

22 participants, with age 63.4±4.6 years in BILEVEL group and 64.3±5.6 in standard medical care group. All patients underwent cardiosurgery procedure (6 ‐ CABG, 16 ‐ valves replacement). Causes: HF, Mitral valve dysfunction and arrhythmias.

Interventions

BILEVEL group: EPAP=5.1±0.3 cm H2O; e IPAP= 9.8±1.1 cmH2O. N=11.
Control group: standard medical care + O2 mask. N= 11.
Co‐intervention: not related.

Outcomes

  1. Mortality

  2. Need tracheal intubation

  3. Arterial blood gases (PaO2, PaCO2) and pH

  4. Vital signs (BR, BP, HR)

  5. Length of hospital stay

  6. Length of ICU stay

  7. Incidence of acute myocardial infarction (follow‐up)

  8. Droupouts/ withdrawal

  9. Side effects

  10. Treatment failure

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Bellone 2004

Methods

Single centre randomised controlled trial (used a computer‐generated random number sequence in closed envelopes with identification numbers that were stored in emergency room), parallel design, unblinded, using ITT approach. No patients were lost to follow up. Written consent was obtained from the patients' relatives at the start of the protocol. Setting: emergency department.

Participants

46 participants (23 males and 23 females), with age 77.3±7.3 years in BILEVEL group and 76.8±7 in CPAP group. Diagnosis criteria: bilateral rales , and typical findings of congestion on chest radiograph, without a history suggesting pulmonary aspiration or pneumonia, SaO2<90% with O2 mask>5l/min via reservoir face mask, dyspnoea, BR>30b/min, use accessory muscles or paradoxical abdominal motion in association with tachycardia, HR>100b/min, cardiac gallops. History: heart failure, coronary artery disease, diabetes, hypertension, COPD, chronic atrial fibrillation and chronic kidney failure. Causes: respiratory infections, hypertension, tachyarrhythmia, other. Excluded patients: patients required endotracheal intubation immediately or already intubated, presenting a respiratory or cardiac arrest, cardiogenic shock (SBP<90mmHg), or at the time of admission had an acute coronary syndrome, patients unresponsive, with diagnosis of pneumonia, agitated, and unable to cooperate or if they had any condition that precluded application of a face mask.

Interventions

CPAP group: PEEP=10 cmH2O. N=22, TIME=103±45 minutes.
BILEVEL group: EPAP=5 cm H2O; e IPAP= 15 cm H2O initially, and then adjusted to obtain a tidal volume of more than 400ml, without leakage. N=24, time= 98±39 minutes.
Co‐intervention: morphine sulfate, furosemide, sodium nitroprusside, glyceryl trinitrate,digoxin, oxygen therapy to obtain SaO2>90%.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases (PaCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Droupouts/ withdrawal

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
Bellone 2005

Methods

Single centre randomised controlled trial (used a computer‐generated random number sequence in closed envelopes with identification numbers that were stored in emergency room), parallel design, unblinded, using ITT approach. No losses to follow up. Written consent was obtained from the patients' relatives at the start of the protocol. Setting: Niguarda Hospital Emergency Department ‐ Milan ‐ Italy.

Participants

36 participants (12 males and 24 females), with age 76.8±6.6 years in BILEVEL group and 76.8±6.9 in CPAP group. Diagnosis criteria: typical findings of congestion on chest radiograph and widespread rales without a history suggesting pulmonary aspiration or pneumonia, SaO2<90% with O2 mask >5l/min, dyspnoea, BR >30b/min, use accessory muscles or paradoxical abdominal motion in association with tachycardia, HR>100b/min, cardiac gallop. History: heart failure, acute myocardial infarction, diabetes, hypertension. Causes : respiratory infections, hypertension, tachyarrhythmia, myocardial infarction, others. Excluded patients: patients with PaCO2 <45mmHg, required endotracheal intubation or already intubated, presenting a respiratory or cardiac arrest, cardiogenic shock (SBP<90mmHg), severe renal failure, presenting clinical and history findings of chronic obstructive pulmonary disease or previously enrolled in other studies.

Interventions

CPAP group: PEEP=10 cmH2O. N=18, TIME=220±82 minutes.
BILEVEL group: EPAP=5 cm H2O; e IPAP= 15 cm H2O initially, and then adjusted to obtain a tidal volume of more than 400ml, without leakage. N=18, time= 205±68 minutes.
Co‐intervention: morphine, furosemide, sodium nitroprusside, glyceryl trinitrate,digoxin, oxygen therapy to obtain SaO2>90%.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases (PCO2, pH)

  4. Vital signs (BR)

  5. Droupouts/ withdrawals

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Bersten 1991

Methods

Single centre randomised controlled trial (random selection of a coloured cap), parallel design, unblinded, lack of intention‐to‐treat analysis confirmed on study assessment. Loss to follow up: no patients in standard medical care group and one patient in CPAP group. Patients or next‐of‐kin were aware through informed consent. Setting: emergency department or ward to the intensive care unit (ICU).

Participants

40 participants (13 males and 27 females), with age 75±6 years in standard medical care group and 76±6 in CPAP group. Diagnosis criteria: dyspnoea of sudden onset with typical finds on chest radiographs and widespread rales without a history suggesting pulmonary aspiration or infection, jugular venous pressure elevated and third heart sound. Causes: acute myocardial infarction, myocardial ischaemia, congestive heart failure. Excluded patients: acute myocardial infarction with shock, SBP<90mmHg, severe stenotic valvular disease, chronic airflow obstruction with known carbon dioxide retention.

Interventions

CPAP group: PEEP= 10 cmH2O. N=19, TIME=9.3±4.9 hours.
Control group: O2 mask + standard medical care. N= 20.
Co‐intervention: furosemide, morphine, diazepam, nitroglycerin.

Outcomes

  1. Mortality,

  2. Tracheal intubation rate

  3. Arterial blood gases ( PaO2, PaCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Treatment failure

  6. Side‐effects

  7. Droupouts/ withdrawals

  8. Length of hospital stay

  9. Length of ICU stay

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Allocation concealment (selection bias)

High risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

High risk
Crane 2004

Methods

Multicenter randomised controlled trial (2 university hospitals). Randomization procedure: random numbers produced by Microsoft Excel, assignments were concealed in an opaque envelope. Parallel design, unblinded, using ITT approach. No reported loss to follow up. Patients or next‐of‐kin were aware through informed consent, but in 17 cases, the patient gave verbal consent. Setting: emergency department.

Participants

60 participants (23 males and 37 females), with age 74.6±11.1 years in standard medical care group, 74.9±12.2 in CPAP group and 76±8.4 in BILEVEL group. Diagnosis criteria: BR >23 bpm, Rx consistent with pulmonary oedema, pH <7,35, widespread pulmonary crepitations and diaphoresis. History: heart failure, ischaemic heart disease, DM, Hypertension, COPD. Excluded patients: Hypotension (SBP<90mmHg), T>38oC, patients requiring thrombolysis for myocardial infarction or dialysis for renal impairment, patients with impaired consciousness or with dementia.

Interventions

CPAP group: PEEP=10 cm H2O. N=20.
BILEVEL group: EPAP=5 cm H2O; e IPAP= 15 cmH2O. N=20.
Control group: standard medical care+O2 mask (To maintain SaO2 >90%). N= 20.
Co‐intervention: furosemide, nitrates and diamorphine (without restriction)

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases ( PaO2, PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Compliance of patient

  7. Treatment failure

  8. Side‐effects

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
Delclaux 2000

Methods

Multicenter randomised controlled trial (6 centres). Randomization procedure: randomisation computer‐generated; sealed envelopes were used to randomly assign patients to their treatment group. Parallel design, using ITT approach. Blindness only of the investigators. No patient were lost to follow‐up. Informed consent was obtained of the all patients. Setting: intensive care unit (ICU).

Participants

123 participants, but only a subgroup with 42 participants had CPO. Diagnosis criteria: acute respiratory insufficiency (PaO2/FiO2<300 with O2 =10l/min, bilateral lung infiltrates on a posteroanterior chest radiograph, randomisation within 3 hours after the criteria were first fulfilled. Because a cardiogenic mechanism contributing to the pulmonary oedema might have had a substantial influence on the study results, the randomisation was stratified based on whether there was an underlying cardiac disease. Causes: ischaemia, arrhythmias, fluid overload, hypertension, valvular disease, pneumonia, aspiration, systemic inflammatory response syndrome (SIRS), shock, other. Excluded patients: younger than 18 years, intubation was refused or contraindicated, history of COPD, acute respiratory acidosis (defined as a pH<7,30 and PaCO2 > 50 mmHg, systolic blood pressure less than 90 mmHg under optimal therapy (fluid repletion), ventricular arrhythmias, coma or seizures, life‐threatening hypoxaemia, use of epinephrine or norepinephrine, and the inability to clear copious airway secretions.

Interventions

CPAP group: PEEP= 7,5 cmH2O with increase or decrease 2,5 cmH2O. N=22, TIME=6 hours or more.
Control group: standard medical care+O2 mask. N= 20.
Co‐intervention: diuretics, antibiotics.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Low risk

Adherence to the intention‐to‐treat principle

Low risk
Ferrari 2007

Methods

Single centre randomised controlled trial (according to a random sequence previously generated from a table of random numbers, the assignments were placed in closed boxes, with identification numbers, stored in the HDU), parallel design, unblinded, lack of intention‐to‐treat analysis. Two patients were lost (Two patients refused) to follow up. Written consent was obtained from the patients. Setting: High Dependency Unit (HDU) of the Emergency Department.

Participants

52 participants (23 males and 29 females), with age 74.2±9.7 years in BILEVEL group and 76.7±9.2 in CPAP group. Diagnosis criteria: rapid onset of symptoms,severe dyspnoea at rest, respiratory rate 30 breaths/min, use of accessory respiratory muscles, oxygen saturation by pulse oximetry (Spo2) 90% with a fraction of inspired oxygen (Fio2) of 60% via a Venturi mask, radiologic findings of ACPE. Causes : hypertensive crisis, tachyarrhythmia, chronic Ischaemic cardiomyopathy, dilated cardiomyopathy and valvular heart disease. Excluded patients: acute coronary syndrome on hospital admission,18 haemodynamic instability (systolic BP 90 mm Hg with dopamine or dobutamine infusion 5 g/kg/min) or life‐threatening arrhythmias, need for immediate endotracheal intubation (respiratory arrest, bradypnoea, or gasping for air), inability to protect the airways, impaired sensorium (unconsciousness or agitation), inability to clear secretions, respiratory tract infection, recent oesophageal/gastric surgery, GI bleeding, facial deformities, hematologic malignancy or cancer with an Eastern Cooperative Oncology Group performance status 2, chronic respiratory failure necessitating long‐term oxygen therapy, diagnosis of myocardial infarction, pulmonary embolism, pneumonia, exacerbation of COPD, pneumothorax in the previous 3 months, and denial or refusal of intubation.

Interventions

CPAP group: PEEP = 8.8±1.9 cmH2O. N = 27, TIME= 8.1±8.3 hours.
BILEVEL group: EPAP = 7±1.2 cm H2O e IPAP= 15±3.1 cmH2O . N=25, TIME= 6.0±4.7 hours.
Co‐intervention:

Outcomes

  1. Rate of acute myocardial infarction

  2. Mortality

  3. ETI

  4. Duration of ventilatory assistance

  5. HDU length of stay

  6. Hospital length of stay

  7. Arterial blood gases (PaCO2, pH, PaO2/FiO2, SaO2)

  8. Vital signs (BR, HR)

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

High risk
Ferrari 2010

Methods

Multicenter (3 ‐ Italy) randomised controlled trial (according to a random sequence previously generated from a table of random numbers, the assignments were placed in closed boxes, each with an identification number and were stored in the ED), parallel design, unblinded, using intention‐to‐treat analysis. Written consent was obtained from patients’ next of kin if patients were unable to give informed consent due to the severity of their disease. Setting: Emergency Department.

Participants

80 adults participants with age 76.55±9.48 years in BILEVEL group and 77.25±9,17 in CPAP group, with acute respiratory failure due to severe ACPE. Diagnosis criteria: severe dyspnoea at rest, respiratory rate > 30 breaths/min, use of accessory respiratory muscles, PaO2/FiO2 < 200 despite oxygen via Venturi mask with a FiO2 of 60%, radiologic findings of ACPE. Causes : hypertensive crisis, dysrhythmias, UA/NSTEMI, respiratory infections. Exclusion criteria: STEMI (patients with unstable angina/Non‐ST elevation MI were included in the study protocol),haemodynamic instability (systolic arterial pressure 90 mmHg), need for immediate ETI (respiratory arrest, bradypnoea), Inability to protect the airways, impaired sensorium (severe agitation or unconsciousness), COPD, exacerbation, pulmonary embolism, pneumonia, recent oesophageal‐gastric surgery, gastrointestinal bleeding, facial deformities, hematological malignancy or cancer with ECOG performance status > 2.

Interventions

CPAP group: PEEP = 8.88±1.77 cmH2O. N = 40, TIME = 8.46±7.14 hours.
BILEVEL group: EPAP = 6.75±1.44 cmH2O e IPAP= 14±3.11 cmH2O . N=40, TIME = 5.91±4.01 hours.
Co‐intervention: furosemide, glycerol trinitrate, sodium nitroprusside, morphine hydrochloride.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Duration of ventilatory assistance

  4. Hospital length of stay

  5. Arterial blood gases (PaCO2, PaO2/FiO2, SaO2) and pH

  6. Vital signs (BP, BR, HR)

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported if there were drop‐outs over the monitoring of patients.

Selective reporting (reporting bias)

High risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
Ferrer 2003

Methods

Multicenter (3 ‐ Spain), prospective, randomised (randomly allocated within 24‐hours, using a computer‐generated table for each centre), controlled trial, parallel‐group, using intention‐to‐treat analysis. No patient were lost to follow‐up. Informed consent was obtained in all cases. Setting: ICU.

Participants

Group of patients with acute hypoxaemic respiratory failure whose sub‐group contained 30 patients with pulmonary oedema cardiogenic (10 males and 20 females), with age 76±9 years in standard medical care group and 71±13 in BILEVEL group. Diagnosis criteria: dyspnoea of sudden onset with physical findings consistent with pulmonary oedema, such as widespread rales with or without third heart sound, and typical findings of congestion on a chest x‐ray. Exclusion criteria: hypercapnia (PaCO2 of more than 45 mm Hg) on admission; need for emergency intubation; recent oesophageal, facial, or cranial trauma or surgery; severely decreased consciousness (a Glasgow coma score of 11 or less); severe haemodynamic instability despite fluid repletion and use of vasoactive agents; a lack of cooperation; tracheotomy or other upper airway disorders; severe ventricular arrhythmia or myocardial ischaemia; active upper gastrointestinal bleeding; an inability to clear respiratory secretions; and more than one severe organ dysfunction in addition to respiratory failure.

Interventions

BILEVEL group. N=15.
Control group: standard medical care + O2 mask (To maintain SaO2 >92%). N= 15.

Outcomes

  1. Tracheal intubation rate

  2. Mortality

  3. ICU length of stay

  4. Hospital length of stay

  5. Droupouts/ withdrawals

  6. Side‐effects

  7. Treatment failure

  8. Arterial blood gases (PaCO2, pH, PaO2/FiO2, SaO2)

  9. Vital signs (BR, BP, HR)

Notes

Mask: face mask or nasal mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
Fontanella 2010

Methods

Randomised controlled trial. Losses to follow up not reported. Informed consent not described. Setting: Cardiac Care Unit (CCU).

Participants

40 participants with age 80±7 in CPAP group and 76±9 in BILEVEL group.Diagnosis criteria: patients with acute cardiogenic pulmonary oedema.

Interventions

CPAP group: PEEP = 8±2 cmH2O. N = 21.
BILEVEL group: EPAP = 10±2 cmH2O e IPAP= 18±3 cmH2O . N=19.
Co‐intervention: ?

Outcomes

  1. Tracheal intubation rate

  2. Mortality

  3. ICU length of stay

  4. Arterial blood gases (PaO2, pH, PaO2/FiO2, SaO2)

  5. Vital signs (BR, BP, HR)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported if there were drop‐outs over the monitoring of patients.

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Frontin 2010

Methods

Single centre (France) randomised controlled trial (by balanced blocks of random numbers was provided by telephone using sealed opaque envelopes), parallel design, unblinded, not using ITT approach by Cochrane ‐ All patients after randomisation. Two patients (in the CPAP group) refused the ongoing use of their data once their condition stabilised and were not analysed. Informed consent was obtained from patients or their surrogates. Setting: out‐of‐hospital medical emergencies is the responsibility of the "Service d'Aide Médicale Urgente" (SAMU) and continued on ICU.

Participants

124 participants randomised, 122 analysed (52 males and 70 females), with age 79.3±10.5 years in standard medical care group and 79.4±10.7 in CPAP group. Inclusion criteria: 18 years or older with clinical symptoms of ACPE such as orthopnoea, diffuse crackles without evidence of pulmonary aspiration or infection, pulse oximetry (SpO2) less than 90% and a respiratory rate greater than 25 breaths per minute. Excluded patients: cardiovascular collapse or an impaired level of consciousness, acute myocardial infarction, or if they had an immediate need for intubation. Patient with a history of gastric surgery (b8 days) and patients vomiting were also excluded

Interventions

CPAP group: PEEP= 10 cmH2O. N=60.
Control group: standard medical care+O2 mask. N= 62.
Co‐intervention: furosemide ‐ 1mg/Kg, morphine pre‐hospital, isosorbide dinitrate injections was 4 (range, 3‐5) in both groups.

Outcomes

  1. Mortality 30 days

  2. Tracheal intubation rate

  3. Arterial blood gases (PaO2, PaCO2)

  4. Vital signs (BR, BP, HR)

  5. Side‐effects

  6. Intensive care unit (ICU) length of stay

  7. Length of hospital stay

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Gray 2008

Methods

Multicenter, open, prospective, randomised, controlled trial, parallel‐group trial with three treatment groups:
standard oxygen therapy, CPAP, and bilevel NIPPV. Patients were randomly assigned to one of the three treatments at a 1:1:1 ratio with the use of a 24 hour telephone randomisation service. The randomisation sequence was stratified according to centre, with variable block length. Lack of intention‐to‐treat analysis. Eighty‐seven patients were excluded after randomisation because of ineligibility or previous recruitment into the trial. Informed written or witnessed oral consent from the patient or relative was obtained. Setting: emergency department.

Participants

1156 participants, 56.9% were women, with age 79±9 years in standard medical care group and 78±10 in CPAP group and 77±10 in BILEVEL group. Diagnosis criteria: age of more than 16 years, a clinical diagnosis of acute cardiogenic pulmonary oedema, pulmonary oedema shown by a chest radiograph, a respiratory rate of more than 20 breaths per minute, and an arterial hydrogen ion concentration of greater than 45 nmol per litre (pH <7.35). Excluded patients: patients requirement for a lifesaving or emergency intervention, such as primary percutaneous coronary intervention; inability to give consent; or previous recruitment into the trial.

Interventions

CPAP group: PEEP= 10±4 cmH2O. N=346. Time = 2.2±1.5hours.
Bilevel NPPV group: EPAP= 7±3 cm H2O e IPAP= 14±5 cmH2O. N=356. Time= 2.0±1.3 hours.
Control group: standard medical care + O2 mask with a reservoir. N= 367.
Co‐intervention: nitrates, diuretics and opioids.

Outcomes

  1. 7‐day mortality

  2. 7‐day tracheal intubation rate

  3. 30‐day mortality

  4. Admission to the critical care unit

  5. Arterial blood gases ( PaO2, PaCO2, pH)

  6. Vital signs (BR, BP, HR)

  7. Incidence of acute myocardial infarction

  8. Compliance of patients with NPPV

  9. Side‐effects and complications

  10. Length of hospital stay

  11. PEEP levels, PS levels and bilevel NPPV vs CPAP.

  12. Duration of therapy.

Notes

Although the study reports that held ITT, analyses submitted have not included all randomised patients (follow‐up bias), as well as, it was not described as the total distribution of randomisation by group. Results were presented in the format completely different from other studies included, making impossible their inclusion in meta‐analyses (variables dicotômicas acute myocardial infarction and Intolerance to the allocated treatment not possessed N total to perform ITT or were analysed in times different from those envisaged in this review ‐ mortality and intubation in 7 or 30 days). Continuous variables were presented just as mean value of the difference between 0 and 1 hour after the intervention and not as mean and standard deviation. However the author, although asked, did not send the data in the format required to include in Meta‐analysis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Low risk

Adherence to the intention‐to‐treat principle

High risk
Kelly 2002

Methods

Single centre randomised controlled trial (by balanced blocks using sealed envelopes), parallel design, unblinded, using ITT approach. No patients were lost to follow up. Informed consent was obtained of the patients. Setting: emergency department and continued in the high dependency unit.

Participants

58 participants (26 males and 32 females), with age 78±2 years in standard medical care group and 77±2 in CPAP group. Diagnosis criteria: acute onset of breathlessness, BR>20bpm, bilateral basal crackles or chest auscultation, Rx typical of pulmonary oedema. Causes: left ventricular systolic dysfunction and hypertensive crisis; the CPAP group had more severe disease with a slightly greater acidosis and hypercapnia. Excluded patients: patients with radiograph consistent with pneumonia or pneumothorax, or if they had received pre‐hospital treatment with intervention other than oxygen, diuretics or opiates.

Interventions

CPAP group: PEEP= 7.5 cmH2O. N=27, TIME= minimum of 6 hours.
Control group: standard medical care+O2 mask. N= 31. (FiO2=60%).
Co‐intervention: furosemide, morphine sulfate, nitrate.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases ( PaO2, PaCO2)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Treatment failure

  7. Side‐effects

  8. Droupouts/ withdrawals

  9. Length of hospital stay

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
L'Her 2004

Methods

Multicenter randomised controlled trial, in three teaching hospitals in France. The randomisation protocol was computer generated and equalised in groups of 10 patients, parallel design, unblinded, using ITT approach. No patients were lost to follow up. Patients or their next of kin gave written informed consent. Setting: emergency department.

Participants

89 participants (37 males and 51 females), with age 84±6 years in standard medical care group and 84±6 in CPAP group. Diagnosis criteria: Age similar or more than 75 year, acute hypoxaemic respiratory failure (PaO2/ FiO2<300 despite O2> 8l/min for 15 minutes), BR> 25bpm, contraction of accessory muscles, clinical examination: systolic and/or diastolic hypertension, widespread crackles or wheezing; medical record : previous cardiomyopathy, and/or acute dyspnoea with progressive orthopnoea; electrocardiographic tracing (Q waves and/or abnormalities in the T wave and ST segment; left ventricular hypertrophy, bundle branch block, atrial fibrillation); and chest radiography ( cardiac enlargement with a cardiothoracic ratio>50%, and/or pulmonary congestion with Kerley B lines, alveolar filing, pleural effusions) compatible with a diagnosis of cardiogenic pulmonary oedema. Causes: Tachyarrythymia, acute Ischaemic heart disease, hypertensive crises, respiratory tract infection, undiagnosed. Exclusion criteria: Glasgow Coma Scale less or similar 7, SpO2 similar or less 85% despite oxygen, haemodynamic instability, chronic respiratory insufficiency.

Interventions

CPAP group: PEEP= 7.5 cmH2O. N=43, TIME=8±6 hours.
Control group: standard medical care+O2 mask. N= 46.
Co‐intervention: furosemide, nitroglycerin, glyceryl‐trinitrate, morphine, isosorbide dinitrate.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases ( PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Treatment failure

  6. Side‐effects

  7. Droupouts/ withdrawals

  8. Length of hospital stay

  9. Compliance of patient

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

High risk

Detection bias

Unclear risk

Not reported

Adherence to the intention‐to‐treat principle

Low risk
Levitt 2001

Methods

Single centre randomised controlled trial (from a previously computer‐generated list), parallel design, unblinded, lack of intention‐to‐treat analysis confirmed on study assessment. Four patients were lost to follow up. Informed consent was obtained of the patients. Setting: emergency department.

Participants

42 patients were randomised, but 4 patients did not meet inclusion criteria following randomisation. Therefore, study entry 38 participants (13 males and 25 females), with age 68.5±15 years in standard medical care group and 67.4±15 in BILEVEL group. Diagnosis criteria: tachypnoea, BR>30bpm, diaphoresis or accessory muscle use, pulmonary rales, distended neck veins, peripheral oedema, history CHF (congestive heart failure) and radiograph findings of the pulmonary oedema. Causes: acute congestive heart failure. Excluded patients: patients with radiograph were found not to have CHF or required immediate intubation.

Interventions

BILEVEL group: EPAP= cm H2O e IPAP= cmH2O. N=21, time= 2 hours.
Control group: standard medical care+O2 mask. N= 17.
Co‐intervention: morphine,furosemide, nitroglycerin.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Treatment failure

  4. Incidence of acute myocardial infarction (follow‐up)

  5. Length of hospital stay

Notes

Mask:nasal or face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

High risk

Adherence to the intention‐to‐treat principle

High risk
Liesching 2003

Methods

Single centre randomised controlled trial, parallel design, unblinded, using ITT approach. Losses to follow up not reported. Informed consent not described.

Participants

27 participants. Diagnosis criteria: patients with acute cardiogenic pulmonary oedema. Patients with myocardial infarction at presentation were excluded.

Interventions

CPAP group: PEEP=10 cmH2O. N=14.
BILEVEL group: EPAP=4 cm H2O e IPAP= 12cmH2O. N=13.
Co‐intervention: medical treatment..

Outcomes

  1. Tracheal intubation rate

  2. Incidence of acute myocardial infarction (follow‐up)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported if there were drop‐outs over the monitoring of patients.

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Lin 1991

Methods

Single centre randomised controlled trial, parallel design, unblinded, lack of intention‐to‐treat analysis confirmed on study assessment. 15 patients in CPAP group and 10 patients in O2 group were lost to follow up. Infomed consent was obtained of the patients. Setting: intensive care unit. Wash out of 30 minutes.

Participants

80 patients were randomised, but 25 patients did not meet inclusion criteria following randomisation. Therefore, study entry 55 patients (50 males and 5 females), with age 74.1±8.8 years in standard medical care group and 73.4±8.2 in CPAP group. Diagnosis criteria: Radiologic evidence of acute interstitial or alveolar oedema of cardiac origin, tachypnoea, BR>22bpm, intercostal or suprasternal retractions, PaO2/FiO2 > 200, P(A‐a)O2>200. Causes: CHF, dilated cardiomyopathy, Ischaemic heart disease, hypertensive cardiovascular disease, acute myocardial infarction. Excluded patients: patients unresponsive to speech or unable to maintain a patent airway and who had cardiogenic shock, signs of lung infection, evidence pulmonary embolism, chronic lung disease with CO2 retention at rest.

Interventions

CPAP group: PEEP=3.75±1.76 cmH2O in first hour (pressure was applied by connecting a serial CPAP valve ‐2,5 cm, 5 cm, 7,5 cm, 10 cm, 12,5 cm ‐ to the face mask at each 30 min interval. N=25, TIME=6 hours.
Control group: standard medical care+O2 mask. N= 30.
Co‐intervention: medical treatment of pulmonary oedema was not restricted.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases ( PaO2, PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Droupouts/ withdrawals

  6. Treatment failure

Notes

Mask: face mask.
FiO2=100% full time.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Lin 1995

Methods

Single centre randomised controlled trial, parallel design, unblinded, using ITT approach. No losses to follow up were reported. Informed consent not reported. Setting: emergency department or the patient was recruited during hospitalisation. Wash out of 30 minutes.

Participants

100 participants (90 males and 10 females), with age 73±9 years in standard medical care group and 72±8 in CPAP group. Diagnosis criteria: dyspnoea and tachypnoea, BR>22bpm, use of accessory respiratory muscles, PaO2/FiO2 between 200 and 400, P(A‐a)O2< 250. Rx bilateral diffuse interstitial or alveolar oedema and most rales, and without history aspiration or infection. Causes: CHF, dilated cardiomyopathy, Ischaemic heart disease, hypertensive crisis, acute myocardial infarction. Excluded patients: patients unresponsive, unable to maintain a patent airway and who had cardiogenic shock, ventricular septal rupture, any severe stenotic valvular disease or chronic lung disease.

Interventions

CPAP group: PEEP=3.75±1.7 cmH2O in first hour (pressure was applied by connecting a serial CPAP valve ‐2,5 cm, 5 cm, 7,5 cm, 10 cm, 12,5 cm ‐ to the face mask at each 30 min interval. N=41, TIME=6 hours.
Control group: standard medical care+O2 mask. N= 33.
Co‐intervention: Isosorbide dinitrate, morphine, furosemide, nitroprusside, nitroglycerin, dopamine.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases (PaO2, PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Droupouts/ withdrawals

  6. Length of hospital stay

  7. Length of ICU stay

  8. Treatment failure

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Martin‐Bermudez 2002

Methods

Randomised controlled trial. Losses to follow up not reported. Informed consent not described.

Participants

84 consecutive patients with respiratory failure due to severe cardiogenic pulmonary oedema were randomly assigned to receive either pressure support ventilation plus positive end expiratory pressure or continuous positive airway pressure. Lack of intention‐to‐treat analysis confirmed on study assessment. 3 patients in CPAP group and 1 patients in BILEVEL group were lost after randomisation (a case of respiratory failure by aspiration pneumonia, a re‐acute CPE and two declined to continue participating in the study).

Interventions

CPAP group: time= 107±57 min. N=42.
BILEVEL group: time= 76±50 min . N=42.
Co‐intervention: ?

Outcomes

  1. Mortality

  2. Length of hospital stay

  3. Length of ICU stay

  4. Arterial blood gases (pH, PaCO2, PaO2/FiO2,)

  5. Vital signs (BR, BP, HR)

  6. Incidence of acute myocardial infarction (follow‐up)

  7. Dyspnea score

  8. Tidal volume

Notes

Mask: face mask

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Low risk

Adherence to the intention‐to‐treat principle

High risk
Masip 2000

Methods

Single centre randomised controlled trial (the randomisation sequence was generated by a table of random numbers, the assignments were placed in closed envelopes with identification numbers that were stored in the intensive‐care unit), parallel design, unblinded, lack of intention‐to‐treat analysis confirmed on study assessment. Two patients in standard medical care group and one patient in BILEVEL group were lost to follow up. Patients or next‐of‐kin were aware through informed consent. Setting: emergency department or ward to the intensive care unit (ICU).

Participants

40 participants went randomised, but 3 patients were excluded from the analysis. Therefore, study entry 37 patients (19 males and 18 females), with age 78.5±5 years in standard medical care group, 75.3±11 in BILEVEL group. Diagnosis criteria: dyspnoea of sudden onset with physical findings consistent with pulmonary oedema (widespread rales with or without third heart sound) and typical findings of congestion on a chest radiograph. History: heart failure, acute myocardial infarction, Hypertension, diabetes mellitus, chronic obstructive pulmonary disease. Causes: acute myocardial infarction, hypertensive crisis, hypervolaemia,unstable angina, tachyarrhythmia, respiratory‐tract infection, treatment non‐compliance. Excluded patients: cardiogenic shock (SBP < 90mmHg), severe acute or chronic airflow obstruction without evidence of cardiogenic pulmonary oedema, severe chronic renal failure, neurological impairment, acute myocardial infarction necessitating thrombolysis, evidence of pneumonia, immediate need for intubation, and absence of pulmonary oedema on a first chest radiograph.

Interventions

BILEVEL group: EPAP= 5 cm H2O e IPAP= 15.2±2.4 cmH2O. N=19, time= 254±90 min.
Control group: standard medical care+O2 mask (FiO2 > or = 50%). N= 26
Co‐intervention: morphine, furosemide, glyceryl trinitrate, digoxin.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases (pH)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Dropouts/ withdrawals

  7. Side‐effects

  8. Length of hospital

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not reported.

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Mehta 1997

Methods

Single centre randomised controlled trial (computer random number sequence), parallel design, double‐blind, lack of intention‐to‐treat analysis confirmed on study assessment. 4 patients in CPAP group and 5 patients in BILEVEL group were lost to follow up. Patients or next‐of‐kin were aware through informed consent. Single blind. Setting: emergency department and ICU.

Participants

36 participants (11 males and 25 females), with age 76±7 years in CPAP group and 77±12 in BILEVEL group. Diagnosis criteria: moderate‐to‐severe dyspnoea, BR>30bpm, use of accessory respiratory muscles or paradoxical abdominal motion in combination with tachycardia (heart rate of >100 bpm), cardiac gallops, bilateral rales, and typical findings of congestion on a chest radiograph, without a history suggesting pulmonary aspiration or infection. Causes: acute myocardial infarction, left bundle‐branch block, coronary artery disease. Excluded patients: already intubated, suffering a respiratory or cardiac arrest, had an unstable cardiac rhythm, or a systolic blood pressure (BP)<90mmHg, patients unresponsive, agitated, and unable to cooperate, or if they had any condition that precluded application of a face mask.

Interventions

CPAP group: PEEP=10 cmH2O. N=13, TIME= 6.4±5.8 hours.
BILEVEL group: EPAP=5 cm H2O and IPAP= 15cmH2O. N=14, TIME = 7.1±4.7 hours.
Co‐intervention: morphine, furosemide, isosorbide dinitrate.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Incidence of acute myocardial infarction (follow‐up)

  4. Dropouts/ withdrawals

  5. Side‐effects

  6. Length of hospital stay

  7. Length of ICU stay

Notes

Mask: nasal mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

High risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Moritz 2007

Methods

Multicenter randomised controlled trial (3 centres), randomisation procedure: allocation to treatment was stratified for centre and based on block randomisation of 10 consecutive study numbers. Parallel design, single blind. Lack of intention‐to‐treat analysis confirmed on study assessment, eleven patients were withdrawn because no informed consent was obtained (n7) or because they were lost to follow‐up. Patients or next‐of‐kin gave written informed consent. Setting: emergency department.

Participants

109 participants (57 males and 52 females), with age 77.6±9.4 years in CPAP group and 77.7±9.2 in BILEVEL group. Diagnosis criteria: association of sudden onset of dyspnoea; presence of bilateral rales on auscultation, with no medical history suggesting pulmonary aspiration or infection; or congestion found on chest radiograph. Furthermore, patients had to present 2 of the following severity criteria of respiratory failure: respiratory frequency greater than 30 breaths/min; pulse oxymetry saturation (SpO2) below 90%, with oxygen at greater than 5 L per minute through reservoir facemask; and use of accessory muscles (Patrick scale 3). Causes: acute myocardial infarction, treatment noncompliance, respiratory tract infection, myocardial ischaemia, hypertensive emergency, previous pulmonary oedema. Excluded patients: out‐of‐hospital use CPAP or BILEVEL, temperature above 39°C, altered mental state, severe acute or chronic airflow obstruction, with no evidence of pulmonary oedema, chronic renal failure, evidence of pneumonia, acute myocardial infarction necessitating thrombolysis or primary angioplasty, immediate indication for tracheal intubation, respiratory or cardiac arrest, SpO2 < 85% with 100% FiO2, decreased alertness or major agitation requiring sedation, clinical signs of exhaustion: active contraction of the respiratory accessory muscles, with paradoxic abdominal or thoracic motion.

Interventions

CPAP group: PEEP=7.7±2.1 cmH2O. N=59, TIME= 2.3 hours.
BILEVEL group: EPAP=4.9±0.9 cm H2O and IPAP= 12±3.2cmH2O. N=50, time= 2.8 hours.
Co‐intervention: morphine sulfate, furosemide, nitroprusside, sublingual or topical or intravenous nitroglycerin.

Outcomes

  1. Hospital mortality

  2. ETI

  3. Incidence of acute myocardial infarction

  4. Vital signs (pulse rate, systolic and diastolic blood pressure, BR)

  5. Arterial blood gases (PaO2, PCO2, pH)

  6. Acessory muscle use evaluated with Patrick Scale

  7. SpO2

  8. Duration of the ventilation period

  9. Length of hospital stay

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Low risk

Adherence to the intention‐to‐treat principle

High risk
Nava 2003

Methods

Multicenter randomised controlled trial (5 centres), randomisation procedure: the randomisation schedule had a block design for each centre and was generated by an independent statistician who used random numbers (because the level of PaCO2 might have a substantial influence on the study results, the randomisation was balanced according to whether the patients had an admission PaCO2< or >45mmHg), parallel design, unblinded, using ITT approach. No patients were lost to follow up. Patients or next‐of‐kin were aware through informed consent. Setting: emergency department.

Participants

130 participants (101 males and 29 females), with age 73.1±8.3 years in standard medical care group and 72.1±9.1 in BILEVEL group. Diagnosis criteria: dyspnoea of sudden onset with BR>30bpm, PaO2/FiO2<250, typical finds on chest radiographs (congestion) and physical signs of pulmonary oedema (widespread rales) without a history suggesting pulmonary aspiration or infection. Causes: acute acute myocardial infarction, hypertension, hyperthermia (but not showing any signs of pulmonary infection), arrhythmia, aortic stenosis, mitral regurgitation. Excluded patients: immediate need for endotracheal intubation, severe sensorial impairment, shock, ventricular arrhythmias, life threatening hypoxia (SaO2<80%), acute myocardial infarction necessitating thrombolysis, severe chronic renal failure and pneumothorax.

Interventions

BILEVEL group: EPAP=6.1±3.2 cm H2O e IPAP= 14.5±21,1cmH2O. N=65, time= 11.4±3.6 hours.
Control group: standard medical care+O2 mask (to maintain an SpO2>90%). N= 65
Co‐intervention: morphine sulfate, furosemide, glyceryl trinitrate.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases (PaO2, PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Compliance of patient

  7. Side‐effects

  8. Length of hospital stay

Notes

Mask: full face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Park 2001

Methods

Single centre randomised controlled trial (computer random number sequence in closed envelopes), parallel design, unblinded, not using ITT approach. Loss to follow up not reported. Patients or guardians were aware through informed consent. Setting: in hospital.

Participants

26 participants (10 males and 16 females), with mean age 69±7 years. Diagnosis criteria: dyspnoea of acute onset or worsening, respiration rate more or similar 25 bpm, Rx compatible with pulmonary congestion. Causes: acute myocardial infarction, hypertensive emergencies, acute ischaemic heart disease, infectious endocarditis or undetermined. Excluded patients: SBP less than 90mmHg, arrhythmias requiring electric cardioversion, decreased consciousness level, bradypnoea, lack of cooperation or agitation, repetitive vomiting, upper digestive haemorrhage, facial deformities or any other decompensated respiratory disease.

Interventions

CPAP group: PEEP= 7.5 cmH2O. N=9, TIME=170±90min.
BILEVEL group: EPAP=4 cm H2O e IPAP= 12cmH2O. N=7, time= 155±38min.
Control group: standard medical care+O2 mask (15l/min). N= 10.
Co‐intervention: Isosorbide dinitrate (5mg) + standard medication

Outcomes

  1. Mortality,

  2. Traqueal intubation rate,

  3. Arterial blood gases ( PaO2, PaCO2, pH),

  4. Vital signs (BR, BP, HR),

  5. Incidence of acute myocardial infarction (follow‐up),

  6. Compliance of patient,

  7. Dropouts/ withdrawals.

Notes

Outcome 6 was poorly reported as a brief comment: BILEVEL group more cooperated and related less dyspnoea.
Mask: CPAP: closed face mask, BILEVEL: nasal mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported.

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Park 2004

Methods

Single centre randomised controlled trial (the patients were randomised with sealed envelopes ‐ nine per envelope ‐ using a 3:3:3 assignment scheme), parallel design, lack of intention‐to‐treat analysis confirmed on study assessment. Two patients in BILEVEL group and one patients in O2 group were lost to follow up. Patients or guardians were aware through informed consent. Setting: in emergency department. Wash out of 6 minutes.

Participants

83 participants went randomised, but 3 patients did not meet inclusion criteria for study entry. Therefore, study entry 80 patients (34 males and 46 females), with age 65±15 years in standard medical care group, 61±17 in CPAP group and 66+/‐14 in BILEVEL group. Diagnosis criteria: More than 16 years, acute onset of severe respiratory distress (BR>25rpm), associated tachycardia and diaphoresis and findings of pulmonary congestion on physical examination and chest Rx 2 hours after randomisation. Causes: acute myocardial infarction, myocardial ischaemia, crisis hypertensive, progressive heart failure, hypervolaemia (20%with CPO severe). Excluded patients: SBP < 90mmHg, decrease consciousness level, intractable vomiting, acute myocardial infarction with persistent ST segment elevation, pulmonary embolism, COPD, pneumonia or pneumothorax .

Interventions

CPAP group: PEEP=11±2 cmH2O. N=27, TIME=102±41min.
BILEVEL group: EPAP=11±2 cm H2O e IPAP= 17±2cmH2O. N=7, time= 124±62min.
Control group: standard medical care+O2 mask (FiO2 > or = 50%). N=26
Co‐intervention: Isosorbide dinitrate, morphine, furosemide, nitroprusside, nitroglycerin

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Incidence of acute myocardial infarction (follow‐up)

  4. Compliance of patient

  5. Dropouts/ withdrawals

  6. Treatment failure

  7. Side‐effects

  8. Length of hospital stay

Notes

Mask: face mask. CPAP or BILEVEL with FiO2=50%.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk
Räsänen 1985

Methods

Single centre randomised controlled trial. The patients were randomly assigned to 1 of 2 group by opening 1 of 40 sealed envelopes. Parallel design, unblinded, using ITT approach. Loss to follow up not reported. Informed consent not described. Wash out of 10 minutes. Setting: intensive care unit (ICU).

Participants

40 participants (13 males and 17 females), with age 73±9 years in standard medical care group and 74±9 in CPAP group. Diagnosis criteria: respiratory failure and clinical and radiologic evidence of acute alveolar pulmonary oedema of cardiac origin, dyspnoea, signs increase respiratory work (intercostal and suprasternal retractions or use of accessory respiration muscles), respiratory rate of more than 25 bpm. PaO2/FiO2<200. Causes: severe heart failure primarily after acute myocardial infarction, acute exacerbation of chronic left ventricular dysfunction, ventricular arrhythmia or acute valve incompetence. Excluded patients: patients unresponsive to speech or unable to maintain patent airway, with lung infection, pulmonary embolism, chronic lung disease with CO2 retention at rest or after treatment PaO2<50mmHg, PaCO2>55mmHg, BR>35bpm.

Interventions

CPAP group: PEEP= 10 cmH2O. N=20, TIME=180min.
Control group: standard medical care+O2 mask (FiO2=28‐30%). N= 20.
Co‐intervention: furosemide, morphine, diazepam, chlorpromazine, nitroglycerin, nitroprusside, digitalis, dopamine and dobutamine.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Arterial blood gases ( PaO2, PCO2, pH)

  4. Vital signs (BR, BP, HR)

  5. Incidence of acute myocardial infarction (follow‐up)

  6. Treatment failure

  7. Side‐effects

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Sharon 2000

Methods

Single centre randomised controlled trial (according to their numerical order on list that had been predetermined by lot), parallel design, unblinded, using ITT approach. No losses to follow up. Informed consent was obtained. Setting: mobile intensive care unit teams in the patient's home or during delivery to the emergency department.

Participants

40 patients went randomised (19 males and 21 females), with age 73±7 years in standard medical care group and 72+/‐6 in BILEVEL group. Diagnosis criteria: symptoms and signs of pulmonary oedema accompanied by oxygen saturation of < 90% measured by pulse oximetry, prior to oxygen administration. Echocardiographics findings: moderate aortic stenosis, moderate mitral regurgitation, ejection fraction. Excluded patients: previous treatment with nitrates above 40 mg/d, or mononitrate or long‐acting trinitrates administered more than twice daily or short acting trinitrates administered more than three times a day; previous treatment with furosemide> 80 mg/d; hypotension (blood pressure <110/70 mmHg); previous adverse effect of nitrates; ST elevations consistent with acute myocardial infarction on baseline ECG; and absence of pulmonary oedema on chest radiograph obtained on arrival to the emergency department.

Interventions

BILEVEL group: EPAP= 4.2±3,.cm H2O, e IPAP=9.3±2.3 cmH2O + ISDN = 3.5±2.5mg. N=20, time=at least 50 minutes.
Control group: O2 mask + high dose IV ISDN =10.8±5.7mg . N= 20.
Co‐intervention: IV ISDN (Isorsobide‐dinitrate), furosemide and morphine

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Incidence of acute myocardial infarction (follow‐up)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Takeda 1997

Methods

Single centre randomised controlled trial, parallel design, unblinded, using ITT approach. Loss to follow up not reported. Patients or guardians were aware through informed consent. Setting: intensive care unit (ICU).

Participants

30 participants (22 males and 8 females), with age 64±9 years in standard medical care group and 69+/‐10 in CPAP group. Diagnosis criteria: dyspnoea of sudden onset, PaO2<80mmHg with FiO2>ou= 50%, typical finds on chest radiographs, and widespread rales without a history suggesting pulmonary aspiration or infection. Causes: acute myocardial infarction, prior myocardial infarction, cardiomyopathy, mitral valve regurgitation. Exclusion criteria: complicated with aspiration and/or pneumonia, immediate need for endotracheal intubation, shock, and life‐threatening hypoxia at study entry.

Interventions

CPAP group: PEEP= 7±3 cmH2O. N=15, TIME=11.9±8.4hours.
Control group: standard medical care+O2 mask. N=15.
Co‐intervention: furosemide, morphine, nitroglycerin, digitalis, dopamine, dobutamine, norepinephrine.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Length of ICU stay

Notes

Mask: nasal mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Unclear risk

The method used was not reported.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Takeda 1998

Methods

Single centre randomised controlled trial (by envelope method), parallel design, unblinded, using ITT approach. No patients were lost after randomisation. Patient's next of kin were aware through informed consent. Setting: coronary care unit (CCU).

Participants

22 participants (17 males and 5 females), with age 75±10 years in standard medical care group and 74±11 in CPAP group. Diagnosis criteria: dyspnoea of sudden onset, PaO2<80mmHg with FiO2= 50%, typical finds on chest radiographs and widespread rales without a history suggesting pulmonary aspiration or infection, typical chest pain 30 minutes creatine kinase twice a least the normal, ECG changes consistent with acute myocardial infarction. Causes: Acute myocardial infarction. Exclusion criteria: complicated with aspiration and/or pneumonia, immediate need for endotracheal intubation, shock, and life‐threatening hypoxia at study entry.

Interventions

CPAP group: PEEP= 7±3 cmH2O. N=11, TIME=48hours.
Control group: standard medical care+O2 mask. N= 11.
Co‐intervention: furosemide, morphine, nitroglycerin, dopamine, dobutamine, norepinephrine, epinephrine.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

Notes

Mask: nasal mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Thys 2002

Methods

Single centre randomised controlled trial (through opaque and sealed envelopes by batches of 20 envelopes), parallel design with placebo, single blind, using ITT approach. None patient went lost. Informed consent was obtained of the patients. Setting: emergency department and intensive care unit (ICU).

Participants

8 participants (5 males and 3 females), with age 77.5±8.38 years. Diagnosis criteria: orthopnoea, bibasilar crackles, bilateral perihilar infiltrates on chest radiograph with cardiomegaly and a compatible clinical history; age more than 18 years, acute onset of moderate‐to‐severe dyspnoea, BR>30 or < 10bpm, hypoxaemia (PaO2 <55mmHg) or need for O2 supplementation, pH<7,33. Excluded patients: immediate indication for endotracheal intubation, major unrest, haemodynamic instability, facial or thoracic trauma, lack of cooperation, difficult adaptation of a facial mask, pulmonary embolism, retrosternal pain suggestive of a acute myocardial infarction.

Interventions

BILEVEL group: EPAP= 6.1±1.5 cmH2O e IPAP= 16.5±1.5 cmH2O. N=3, time= 77.33±16.25 minutes.
Control group: standard medical care+O2 with similar mask (placebo). N= 5.
Co‐intervention: furosemide, isosorbide dinitrate.

Outcomes

  1. Mortality

  2. Tracheal intubation rate

  3. Incidence of acute myocardial infarction (follow‐up)

  4. Side‐effects

  5. Length of hospital stay

  6. Length of ICU stay

Notes

Mask: face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The method used was not reported.

Allocation concealment (selection bias)

Low risk

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Low risk

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

Low risk
Weitz 2007

Methods

Single centre randomised controlled trial, parallel design, unblinded, not using ITT approach. Three patients allocated to the standard group were not followed up because it was obvious on admission that these patients did not suffer from an acute cardiogenic pulmonary oedema. Informed consent was obtained. Setting: mobile intensive care unit teams in the patient's home or during delivery to the emergency department.

Participants

23 participants (12 males and 11 females), with age 72‐92 years in standard medical care group and 54‐86 in BILEVEL group. Diagnosis criteria: severe dyspnoea and consecutively showed additional clinical signs of ACPE (SaO2< 90% and basal rales). Excluded patients: severe uncontrolled agitation, angina, obvious ST elevation in the ECG, emesis and aspiration, cardiogenic shock, life threatening arrhythmias, coma or any obvious need for intubation.

Interventions

BILEVEL group: EPAP= 5 cm H2O e IPAP= 12.5±1.2 cmH2O. N=10.
Control group: standard medical care+O2 with similar mask (placebo). N= 5.
Co‐intervention: furosemide, isosorbide dinitrate.

Outcomes

  1. SaO2 at the time of the hospital admission

  2. Measure the brain natriuretic peptide (BNP)

  3. Mortality

  4. Length of hospital stay

  5. Length of ICU stay

  6. Vital signs (BR, BP, HR)

  7. Dyspnea scale

  8. Tracheal intubation rate

  9. Incidence of acute myocardial infarction (follow‐up)

  10. Side‐effects

Notes

Mask: Face mask.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Allocation concealment (selection bias)

High risk

Inadequate

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Selective reporting (reporting bias)

Unclear risk

Not submitted multiple planning outcomes reported on results.

Detection bias

Unclear risk

Not reported.

Adherence to the intention‐to‐treat principle

High risk

ITT ‐ intention to treat; SaO2 ‐ arterial saturation of oxygen; O2 ‐ oxygen; l/min ‐ litre per minute;
BR ‐ breath rate; b/min ‐ breaths per minute; HR ‐ heart rate; b/min ‐ beats per minute; Rx ‐ radiograph;
CHF ‐ congestive heart failure; CPO ‐ cardiogenic pulmonary oedema; ISDN ‐ isosorbide dinitrate; FiO2 ‐ fraction of inspired oxygen; P(A‐a)O2 ‐ alveolar‐arterial oxygen gradient; PaCO2 ‐ carbon dioxide tension of arterial blood; PaO2 ‐ partial pressure of oxygen in arterial blood; CO2 ‐ carbon dioxide; pH ‐ potential of hydrogen; BP ‐ blood pressure; ICU ‐ intensive care unit; SBP ‐ systolic blood pressure; N ‐ number; IPAP ‐ inspiratory positive airway pressure; EPAP ‐ expiratory positive airway pressure; BILEVEL ‐ bilevel positive airway pressure; PEEP ‐ positive expiratory end pressure; CPAP ‐ continuous positive airway pressure; SMC ‐ standard medical care; STEMI ‐ ST segment elevation myocardial infarction.

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Acosta 2000

The clinical situation is different.

Albert 2000

The clinical situation is different.

Alper 2007

It is not a RCT or QRCT.

Alper 2008

It is not a RCT or QRCT.

Andrade 1998

The clinical situation is different.

Antonelli 2001

It is not a RCT or QRCT.

Aronow 2007

It is not a RCT or QRCT.

Barach 1938

It is not a RCT or QRCT.

Baratz 1992

It is not a RCT or QRCT.

Bavry 2008

It is not a RCT or QRCT.

Bellone 2002

The outcomes did not meet the inclusion criteria.

Blomqvist 1991

Study with dogs.

Bollaert 2002

Study involve other kind of ventilatory support (PAV)

Bouquin 1998

It is not a RCT or QRCT.

Bradley 2000

The clinical situation is different.

Brezins 1993

Study involve other kind of ventilatory support (invasive mechanical ventilation).

Brijker 1999

It is not a RCT or QRCT.

Brochard 1998

It is a letter commenting the L'Her's article.

Chadda 2002

The outcomes did not meet the inclusion criteria.

Chen 2008

Compare NPPV vs. mechanical ventilation.

Crane 2002

It is not a RCT or QRCT.

Craven 2000

It is not a RCT or QRCT.

Cross 2000

It is not a RCT or QRCT.

Cross 2003

This is study is in patients with acute respiratory failure and include a subgroup with pulmonary edema (inclusion criteria not clear for cardiogenic pulmonary edema). However, although the author have been contected, he is not replay.

Cydulka 2005

It is a letter commenting the Nava's article.

Domenighetti 2002

It is not a RCT or QRCT.

Du Cailar 1975

It is not a RCT or QRCT.

Eaton 2002

The clinical situation is different.

Evans 2001

It is not a RCT or QRCT.

Fromm 1995

It is not a RCT or QRCT.

Giacomini 2003

It is not a RCT or QRCT.

Girou 2003

The clinical situation is different.

Gorbunova 2005

The end point doesn't similar commended in protocol.

Gray 2009

It is the same study published in New England in 2008 by Gray et al.

Guerra 2005

It is not a RCT or QRCT.

Guntupalli 1984

It is not a RCT or QRCT.

Gust 1998

It is a letter to the editor.

Hao 2002

It is not a RCT or QRCT.

Hess 2004

It is not a RCT or QRCT.

Hilberg 1997

It is not a RCT or QRCT.

Hipona 1996

It is a letter to the editor.

Hoffman B 1999

It is not a RCT or QRCT.

Hoffmann 1999

It is not a RCT or QRCT.

Holt 1994

It is not a RCT or QRCT.

Hotchkiss 1998

It is not a RCT or QRCT.

Hubble 2006

It is not a RCT or QRCT.

Hughes 1999

It is a letter to the editor.

Iapichino 2004

It is not a RCT or QRCT.

Jackson 2000

It is not a RCT or QRCT.

Jackson 2001

It is not a RCT or QRCT.

Jackson R 2001

It is not a RCT or QRCT.

Kallio 2003

It is not a RCT or QRCT.

Keenan 2004

It is not a RCT or QRCT.

Kelly 2001

It is a letter to the editor.

Kiely 1998

The outcomes did not meet the inclusion criteria.

Kindgen‐Milles 2000

It is not a RCT or QRCT.

Kosowsky 2000

It is not a RCT or QRCT.

Kosowsky 2001

It is not a RCT or QRCT.

Kramer 1995

This is study is in acute respiratory failure and include only two patients with cardiogenic pulmonary edema that received NPPV and nobody received CPAP or SMC.

L'Her 1998

It is not a RCT or QRCT.

L'Her E 1998

It is not a RCT or QRCT.

Lal 1969

The study test only different oxygen masks.

Lapinsky 1994

It is not a RCT or QRCT.

Leman 2005

It is a RCT, but only compared two different brands of CPAP equipment.

Lenique 1997

It is not a RCT or QRCT.

Li 2004

It is a RCT, it is Chinese paper  whose data was translated by Cochrane, but dichotomous variables advocated not were analyzed and the continuous variables analysis happened in different period of advocated ‐ 2hs and 24hs after the start of the intervention.

Liesching T 2003

It is not a RCT or QRCT.

Lo Coco 1997

It is not a RCT or QRCT.

Mackay CA 2000

It is a Poster of Congress. Did not assess relevant outcomes.

Masip 2008

It is not a RCT or QRCT.

Massaria 1976

It is not a RCT or QRCT.

Meduri 1991

The clinical situation is different. It was conducted in patients with COPD or asthma.

Mehta 2000

The outcomes did not meet the inclusion criteria.

Mehta 2004

It is not a RCT or QRCT.

Mehta 2005

It is not a RCT or QRCT.

Minuto 2003

It is not a RCT or QRCT.

Mollica 2001

It is not a RCT or QRCT.

Moritz 2003

The outcomes did not meet the inclusion criteria.

Murray 2002

It is not a RCT or QRCT.

Murray 2003

It is not a RCT or QRCT.

Nadar 2005

It is not a RCT or QRCT.

Nava 2002

It is not a RCT or QRCT.

Newberry 1995

It is not a RCT or QRCT.

Newby 2007

It is a brief presentation of RCT published in The New England in 2008 by Gray et al.

Nikki 1982

The study compares CPAP vs. mechanical ventilation.

Niranjan 1998

It is a letter to the editor with comment about noninvasive ventilation.

Panacek 2002

It is not a RCT or QRCT.

Pang 1998

It is not a RCT or QRCT.

Park 2005

It is not a RCT or QRCT.

Park 2006

It is an article of review.

Perel 1983

It is not a RCT or QRCT.

Perkins 2006

It is not a RCT or QRCT.

Philip‐joet 1999

The clinical situation is different.

Plaisance 2007

It is a RCT, but this study cross‐over, the groups were compared in different times were different from those described in this review.

Pollack 1996

It is not a RCT or QRCT.

Poponick 1999

It is not a RCT or QRCT.

Popova 2010

The outcomes did not meet the inclusion criteria.

Poulton 1936

It is not a RCT or QRCT.

Rabatin 1999

It is not a RCT or QRCT.

Rasanen J 1985

It is not a RCT or QRCT.

Rizk 1982

It is not a RCT or QRCT.

Roche 2003

The clinical situation is different.

Rusterholtz 1999

It is not a RCT or QRCT.

Rutherholtz 2008

It is a RCT, but compared CPAP vs.PAV.

Sacchetti 2001

It is a letter to the editor .

Sachetti 1995

It is not a RCT or QRCT.

Salvucci A 2001

It is not a RCT or QRCT.

Sarullo 2004

It is not a RCT or QRCT.

Schettino 2008

It is not a RCT or QRCT.

Severinghaus 2002

It is not a RCT or QRCT.

Simonds 2000

It is not a RCT or QRCT.

Sinuff 2000

It is not a RCT or QRCT.

Somauroo 2000

The clinical situation is different. It was conducted in patients with chronic congestive heart failure.

Sutton 2002

It is a letter to the editor.

Trevisan 2008

It is a RCT, but compared It is a RCT, but compared NPPV as a method of weaning.

Uy 2003

The study compares CPAP vs. mechanical ventilation.

Uy 2004

It is a RCT, but compared It is a RCT, but compared CPAP vs.invasive mechanical ventilation

Vaisanen 1987

The outcomes did not meet the inclusion criteria.

Valipour 2004

It is not a RCT or QRCT.

Werdan 1999

It is not a RCT or QRCT.

Widger 2001

It is not a RCT or QRCT.

Wood 1998

This is study is in acute respiratory failure and include a subgroup with cardiogenic pulmonary oedema. However, although the author have been contected, he is not replay.

Wright 2001

It is a letter to the editor.

Wysocki 1995

This is study is in acute respiratory failure and include a subgroup with cardiogenic pulmonary oedema. However, although the author have been contected, he is not replay.

Wysocki 1999

It is not a RCT or QRCT.

Zhang 2008

The end point doesn’t similar commended in protocol.

108 excluded.

Characteristics of ongoing studies [ordered by study ID]

Jump to:

NCT00554580

Trial name or title

Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

Methods

Allocation: Randomised
Endpoint classification: Efficacy Study
Intervention model: Parallel Assignment
Masking: Open label
Primary purpose: Treatment

Participants

Adults with acute cardiogenic pulmonary oedema

Interventions

  • A: Active comparator

    • usual care of pulmonary acute oedema

    • Intervention: usual care of acute pulmonary oedema

  • B: Experimental

    • CPAP + usual care of pulmonary acute oedema

    • Intervention: continuous positive airway pressure (CPAP)

Outcomes

Death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2. [ Time Frame: 48 hours ]

Brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol [ Time Frame: H0, H6, H24, H48 ]

Starting date

November 6, 2007

Contact information

Notes

http://clinicaltrials.gov/ct2/show/NCT00554580

NCT00912158

Trial name or title

Noninvasive Mechanical Ventilation in Acute Cardiogenic Pulmonary Edema

Methods

Allocation: Randomised
Endpoint classification: Safety/efficacy study
Intervention model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Participants

Adults with acute cardiogenic pulmonary oedema

Interventions

Other: standard therapy (ST)
Device: CPAP and BIPAP

Outcomes

Number of patients who were intubated, arterial blood gases, respiratory rate, blood pressure, cardiac output, intrapulmonary shunt, A‐a oxygen gradient, heart rate, and dyspnoea duration of hospital and ICU stay and mortality [ Time Frame: Hospital stay ]

Starting date

April 8, 2009

Contact information

[email protected]

Notes

http://clinicaltrials.gov/ct2/show/NCT00912158

Data and analyses

Open in table viewer
Comparison 1. Hospital mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) x SMC Show forest plot

20

1107

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.48, 0.89]
Analysis 1.1
Comparison 1 Hospital mortality, Outcome 1 NPPV (CPAP and BILEVEL) x SMC.

Comparison 1 Hospital mortality, Outcome 1 NPPV (CPAP and BILEVEL) x SMC.

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot

18

1023

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.46, 0.91]
Analysis 1.2
Comparison 1 Hospital mortality, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

Comparison 1 Hospital mortality, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

3 NPPV (CPAP and BILEVEL) X SMC‐ ED place Show forest plot

9

717

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.36, 0.86]
Analysis 1.3
Comparison 1 Hospital mortality, Outcome 3 NPPV (CPAP and BILEVEL) X SMC‐ ED place.

Comparison 1 Hospital mortality, Outcome 3 NPPV (CPAP and BILEVEL) X SMC‐ ED place.

4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place Show forest plot

7

365

Risk Ratio (M‐H, Random, 95% CI)

0.48 [0.28, 0.83]
Analysis 1.4
Comparison 1 Hospital mortality, Outcome 4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place.

Comparison 1 Hospital mortality, Outcome 4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place.

5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline Show forest plot

9

603

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.40, 0.88]
Analysis 1.5
Comparison 1 Hospital mortality, Outcome 5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline.

Comparison 1 Hospital mortality, Outcome 5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline.

6 CPAP x SMC Show forest plot

13

699

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.39, 0.94]
Analysis 1.6
Comparison 1 Hospital mortality, Outcome 6 CPAP x SMC.

Comparison 1 Hospital mortality, Outcome 6 CPAP x SMC.

7 CPAP X SMC ‐ sensitivity analysis Show forest plot

12

659

Risk Difference (M‐H, Random, 95% CI)

‐0.12 [‐0.19, ‐0.04]
Analysis 1.7
Comparison 1 Hospital mortality, Outcome 7 CPAP X SMC ‐ sensitivity analysis.

Comparison 1 Hospital mortality, Outcome 7 CPAP X SMC ‐ sensitivity analysis.

8 BILEVEL X SMC Show forest plot

11

506

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.39, 1.09]
Analysis 1.8
Comparison 1 Hospital mortality, Outcome 8 BILEVEL X SMC.

Comparison 1 Hospital mortality, Outcome 8 BILEVEL X SMC.

9 BILEVEL X SMC ‐ sensitivity analysis Show forest plot

9

458

Risk Ratio (M‐H, Random, 95% CI)

0.63 [0.37, 1.09]
Analysis 1.9
Comparison 1 Hospital mortality, Outcome 9 BILEVEL X SMC ‐ sensitivity analysis.

Comparison 1 Hospital mortality, Outcome 9 BILEVEL X SMC ‐ sensitivity analysis.

10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline Show forest plot

7

401

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.34, 1.02]
Analysis 1.10
Comparison 1 Hospital mortality, Outcome 10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline.

Comparison 1 Hospital mortality, Outcome 10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline.

11 BILEVEL X SMC ‐ in patients hypercanics Show forest plot

2

104

Risk Ratio (M‐H, Random, 95% CI)

0.20 [0.04, 0.86]
Analysis 1.11
Comparison 1 Hospital mortality, Outcome 11 BILEVEL X SMC ‐ in patients hypercanics.

Comparison 1 Hospital mortality, Outcome 11 BILEVEL X SMC ‐ in patients hypercanics.

12 CPAP X BILEVEL Show forest plot

12

694

Risk Ratio (M‐H, Random, 95% CI)

1.10 [0.61, 1.97]
Analysis 1.12
Comparison 1 Hospital mortality, Outcome 12 CPAP X BILEVEL.

Comparison 1 Hospital mortality, Outcome 12 CPAP X BILEVEL.

13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline Show forest plot

9

518

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.45, 2.14]
Analysis 1.13
Comparison 1 Hospital mortality, Outcome 13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline.

Comparison 1 Hospital mortality, Outcome 13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline.

14 CPAP X BILEVEL ‐ in patients hypercanics Show forest plot

2

98

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.33, 3.37]
Analysis 1.14
Comparison 1 Hospital mortality, Outcome 14 CPAP X BILEVEL ‐ in patients hypercanics.

Comparison 1 Hospital mortality, Outcome 14 CPAP X BILEVEL ‐ in patients hypercanics.
Open in table viewer
Comparison 2. EETI rate

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

22

1261

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.36, 0.75]
Analysis 2.1
Comparison 2 EETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 2 EETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot

20

1195

Risk Ratio (M‐H, Random, 95% CI)

0.53 [0.37, 0.78]
Analysis 2.2
Comparison 2 EETI rate, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

Comparison 2 EETI rate, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot

9

621

Risk Ratio (M‐H, Random, 95% CI)

0.44 [0.25, 0.77]
Analysis 2.3
Comparison 2 EETI rate, Outcome 3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline.

Comparison 2 EETI rate, Outcome 3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline.

4 CPAP X SMC Show forest plot

14

825

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.33, 0.67]
Analysis 2.4
Comparison 2 EETI rate, Outcome 4 CPAP X SMC.

Comparison 2 EETI rate, Outcome 4 CPAP X SMC.

5 CPAP X SMC ‐ sensitivity analysis Show forest plot

13

785

Risk Ratio (M‐H, Random, 95% CI)

0.48 [0.34, 0.67]
Analysis 2.5
Comparison 2 EETI rate, Outcome 5 CPAP X SMC ‐ sensitivity analysis.

Comparison 2 EETI rate, Outcome 5 CPAP X SMC ‐ sensitivity analysis.

6 BILEVEL X SMC Show forest plot

12

536

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.26, 1.17]
Analysis 2.6
Comparison 2 EETI rate, Outcome 6 BILEVEL X SMC.

Comparison 2 EETI rate, Outcome 6 BILEVEL X SMC.

7 BILEVEL X SMC ‐ sensitivity analysis Show forest plot

10

470

Risk Ratio (M‐H, Random, 95% CI)

0.45 [0.26, 0.80]
Analysis 2.7
Comparison 2 EETI rate, Outcome 7 BILEVEL X SMC ‐ sensitivity analysis.

Comparison 2 EETI rate, Outcome 7 BILEVEL X SMC ‐ sensitivity analysis.

8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot

7

401

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.22, 0.97]
Analysis 2.8
Comparison 2 EETI rate, Outcome 8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline.

Comparison 2 EETI rate, Outcome 8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline.

9 BILEVEL X SMC ‐ in patients hypercapnics Show forest plot

3

120

Risk Ratio (M‐H, Random, 95% CI)

0.28 [0.12, 0.69]
Analysis 2.9
Comparison 2 EETI rate, Outcome 9 BILEVEL X SMC ‐ in patients hypercapnics.

Comparison 2 EETI rate, Outcome 9 BILEVEL X SMC ‐ in patients hypercapnics.

10 CPAP X BILEVEL Show forest plot

13

721

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.55, 1.97]
Analysis 2.10
Comparison 2 EETI rate, Outcome 10 CPAP X BILEVEL.

Comparison 2 EETI rate, Outcome 10 CPAP X BILEVEL.

11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline Show forest plot

9

518

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.58, 2.33]
Analysis 2.11
Comparison 2 EETI rate, Outcome 11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline.

Comparison 2 EETI rate, Outcome 11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline.

12 CPAP X BILEVEL ‐ in patients hypercapnics Show forest plot

2

98

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.26, 3.21]
Analysis 2.12
Comparison 2 EETI rate, Outcome 12 CPAP X BILEVEL ‐ in patients hypercapnics.

Comparison 2 EETI rate, Outcome 12 CPAP X BILEVEL ‐ in patients hypercapnics.
Open in table viewer
Comparison 3. Incidence of acute myocardial infarction (during intervention)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

8

461

Risk Ratio (M‐H, Random, 95% CI)

1.24 [0.79, 1.95]
Analysis 3.1
Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

3

152

Risk Ratio (M‐H, Random, 95% CI)

0.91 [0.37, 2.24]
Analysis 3.2
Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 2 CPAP X SMC.

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

7

356

Risk Ratio (M‐H, Random, 95% CI)

1.40 [0.78, 2.49]
Analysis 3.3
Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 3 BILEVEL X SMC.

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

7

409

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.39, 1.10]
Analysis 3.4
Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 4 CPAP X BILEVEL.

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 4 CPAP X BILEVEL.

5 BILEVEL X SMC ‐ heterogeneity analysis Show forest plot

6

316

Risk Ratio (M‐H, Random, 95% CI)

1.14 [0.69, 1.88]
Analysis 3.5
Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 5 BILEVEL X SMC ‐ heterogeneity analysis.

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 5 BILEVEL X SMC ‐ heterogeneity analysis.

Open in table viewer
Comparison 4. Incidence of acute myocardial infarction (after intervention)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

4

154

Risk Ratio (M‐H, Random, 95% CI)

0.70 [0.11, 4.26]
Analysis 4.1
Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

2

99

Risk Ratio (M‐H, Random, 95% CI)

1.08 [0.11, 10.23]
Analysis 4.2
Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 2 CPAP X SMC.

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

3

65

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.02, 11.54]
Analysis 4.3
Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 3 BILEVEL X SMC.

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

2

68

Risk Ratio (M‐H, Random, 95% CI)

1.57 [0.57, 4.32]
Analysis 4.4
Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 4 CPAP X BILEVEL.

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 4 CPAP X BILEVEL.

Open in table viewer
Comparison 5. Intolerance to allocated treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

13

1848

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.29, 0.77]
Analysis 5.1
Comparison 5 Intolerance to allocated treatment, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 5 Intolerance to allocated treatment, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

12

692

Risk Ratio (M‐H, Random, 95% CI)

0.42 [0.30, 0.58]
Analysis 5.2
Comparison 5 Intolerance to allocated treatment, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

Comparison 5 Intolerance to allocated treatment, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

3 CPAP X SMC Show forest plot

9

1304

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.36, 0.85]
Analysis 5.3
Comparison 5 Intolerance to allocated treatment, Outcome 3 CPAP X SMC.

Comparison 5 Intolerance to allocated treatment, Outcome 3 CPAP X SMC.

4 BILEVEL X SMC Show forest plot

7

995

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.24, 1.42]
Analysis 5.4
Comparison 5 Intolerance to allocated treatment, Outcome 4 BILEVEL X SMC.

Comparison 5 Intolerance to allocated treatment, Outcome 4 BILEVEL X SMC.

5 CPAP X BILEVEL Show forest plot

3

894

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.35, 2.53]
Analysis 5.5
Comparison 5 Intolerance to allocated treatment, Outcome 5 CPAP X BILEVEL.

Comparison 5 Intolerance to allocated treatment, Outcome 5 CPAP X BILEVEL.
Open in table viewer
Comparison 6. Hospital length of stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

10

542

Mean Difference (IV, Random, 95% CI)

‐0.80 [‐2.10, 0.51]
Analysis 6.1
Comparison 6 Hospital length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 6 Hospital length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

9

519

Mean Difference (IV, Random, 95% CI)

‐0.38 [‐1.35, 0.58]
Analysis 6.2
Comparison 6 Hospital length of stay, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

Comparison 6 Hospital length of stay, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

3 CPAP X SMC Show forest plot

5

337

Mean Difference (IV, Random, 95% CI)

‐0.51 [‐1.69, 0.67]
Analysis 6.3
Comparison 6 Hospital length of stay, Outcome 3 CPAP X SMC.

Comparison 6 Hospital length of stay, Outcome 3 CPAP X SMC.

4 BILEVEL X SMC Show forest plot

7

311

Mean Difference (IV, Random, 95% CI)

‐1.38 [‐3.38, 0.62]
Analysis 6.4
Comparison 6 Hospital length of stay, Outcome 4 BILEVEL X SMC.

Comparison 6 Hospital length of stay, Outcome 4 BILEVEL X SMC.

5 CPAP X BILEVEL Show forest plot

6

402

Mean Difference (IV, Random, 95% CI)

‐0.46 [‐1.99, 1.07]
Analysis 6.5
Comparison 6 Hospital length of stay, Outcome 5 CPAP X BILEVEL.

Comparison 6 Hospital length of stay, Outcome 5 CPAP X BILEVEL.
Open in table viewer
Comparison 7. ICU length of stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

6

222

Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.33, ‐0.45]
Analysis 7.1
Comparison 7 ICU length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 7 ICU length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

3

169

Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.63, ‐0.56]
Analysis 7.2
Comparison 7 ICU length of stay, Outcome 2 CPAP X SMC.

Comparison 7 ICU length of stay, Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

3

53

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐1.37, 0.06]
Analysis 7.3
Comparison 7 ICU length of stay, Outcome 3 BILEVEL X SMC.

Comparison 7 ICU length of stay, Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

3

159

Mean Difference (IV, Random, 95% CI)

0.31 [‐0.78, 1.40]
Analysis 7.4
Comparison 7 ICU length of stay, Outcome 4 CPAP X BILEVEL.

Comparison 7 ICU length of stay, Outcome 4 CPAP X BILEVEL.
Open in table viewer
Comparison 8. Breath rate after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

9

438

Mean Difference (IV, Random, 95% CI)

‐2.86 [‐3.85, ‐1.87]
Analysis 8.1
Comparison 8 Breath rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 8 Breath rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

7

300

Mean Difference (IV, Random, 95% CI)

‐2.39 [‐3.70, ‐1.07]
Analysis 8.2
Comparison 8 Breath rate after one hour, Outcome 2 CPAP X SMC.

Comparison 8 Breath rate after one hour, Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

6

254

Mean Difference (IV, Random, 95% CI)

‐3.52 [‐4.80, ‐2.23]
Analysis 8.3
Comparison 8 Breath rate after one hour, Outcome 3 BILEVEL X SMC.

Comparison 8 Breath rate after one hour, Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

5

218

Mean Difference (IV, Random, 95% CI)

0.57 [1.00, 2.13]
Analysis 8.4
Comparison 8 Breath rate after one hour, Outcome 4 CPAP X BILEVEL.

Comparison 8 Breath rate after one hour, Outcome 4 CPAP X BILEVEL.
Open in table viewer
Comparison 9. Heart rate after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

9

438

Mean Difference (IV, Random, 95% CI)

‐4.01 [‐8.16, 0.15]
Analysis 9.1
Comparison 9 Heart rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 9 Heart rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

7

329

Mean Difference (IV, Random, 95% CI)

‐3.79 [‐6.88, ‐0.70]
Analysis 9.2
Comparison 9 Heart rate after one hour, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

Comparison 9 Heart rate after one hour, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

3 CPAP X SMC Show forest plot

7

300

Mean Difference (IV, Random, 95% CI)

‐4.45 [‐10.81, 1.92]
Analysis 9.3
Comparison 9 Heart rate after one hour, Outcome 3 CPAP X SMC.

Comparison 9 Heart rate after one hour, Outcome 3 CPAP X SMC.

4 CPAP X SMC ‐ heterogeneity analysis Show forest plot

5

191

Mean Difference (IV, Random, 95% CI)

‐4.10 [‐8.93, 0.72]
Analysis 9.4
Comparison 9 Heart rate after one hour, Outcome 4 CPAP X SMC ‐ heterogeneity analysis.

Comparison 9 Heart rate after one hour, Outcome 4 CPAP X SMC ‐ heterogeneity analysis.

5 BILEVEL X SMC Show forest plot

6

254

Mean Difference (IV, Random, 95% CI)

‐4.21 [‐7.77, ‐0.65]
Analysis 9.5
Comparison 9 Heart rate after one hour, Outcome 5 BILEVEL X SMC.

Comparison 9 Heart rate after one hour, Outcome 5 BILEVEL X SMC.

6 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐0.56 [‐5.22, 4.11]
Analysis 9.6
Comparison 9 Heart rate after one hour, Outcome 6 CPAP X BILEVEL.

Comparison 9 Heart rate after one hour, Outcome 6 CPAP X BILEVEL.
Open in table viewer
Comparison 10. Sistolic blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

6

182

Mean Difference (IV, Random, 95% CI)

‐1.64 [‐7.83, 4.56]
Analysis 10.1
Comparison 10 Sistolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 10 Sistolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

6

211

Mean Difference (IV, Random, 95% CI)

0.12 [‐6.56, 6.81]
Analysis 10.2
Comparison 10 Sistolic blood pressure after one hour, Outcome 2 CPAP X SMC.

Comparison 10 Sistolic blood pressure after one hour, Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

4

87

Mean Difference (IV, Random, 95% CI)

1.93 [‐7.94, 11.80]
Analysis 10.3
Comparison 10 Sistolic blood pressure after one hour, Outcome 3 BILEVEL X SMC.

Comparison 10 Sistolic blood pressure after one hour, Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐1.17 [‐10.79, 8.44]
Analysis 10.4
Comparison 10 Sistolic blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

Comparison 10 Sistolic blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

5 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot

3

136

Mean Difference (IV, Random, 95% CI)

2.57 [‐4.30, 9.44]
Analysis 10.5
Comparison 10 Sistolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL ‐ heterogeneity analysis.

Comparison 10 Sistolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL ‐ heterogeneity analysis.

Open in table viewer
Comparison 11. Diastolic blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

5

138

Mean Difference (IV, Random, 95% CI)

‐1.49 [‐6.43, 3.45]
Analysis 11.1
Comparison 11 Diastolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 11 Diastolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

5

167

Mean Difference (IV, Random, 95% CI)

‐0.92 [‐9.10, 7.27]
Analysis 11.2
Comparison 11 Diastolic blood pressure after one hour, Outcome 2 CPAP X SMC.

Comparison 11 Diastolic blood pressure after one hour, Outcome 2 CPAP X SMC.

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot

3

107

Mean Difference (IV, Random, 95% CI)

‐7.32 [‐12.79, ‐1.86]
Analysis 11.3
Comparison 11 Diastolic blood pressure after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

Comparison 11 Diastolic blood pressure after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

4 BILEVEL X SMC Show forest plot

4

87

Mean Difference (IV, Random, 95% CI)

‐0.96 [‐6.09, 4.16]
Analysis 11.4
Comparison 11 Diastolic blood pressure after one hour, Outcome 4 BILEVEL X SMC.

Comparison 11 Diastolic blood pressure after one hour, Outcome 4 BILEVEL X SMC.

5 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐2.60 [‐9.58, 4.37]
Analysis 11.5
Comparison 11 Diastolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL.

Comparison 11 Diastolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL.

6 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot

2

62

Mean Difference (IV, Random, 95% CI)

‐7.86 [‐13.03, ‐2.70]
Analysis 11.6
Comparison 11 Diastolic blood pressure after one hour, Outcome 6 CPAP X BILEVEL ‐ heterogeneity analysis.

Comparison 11 Diastolic blood pressure after one hour, Outcome 6 CPAP X BILEVEL ‐ heterogeneity analysis.

Open in table viewer
Comparison 12. Mean blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

3

256

Mean Difference (IV, Random, 95% CI)

‐2.41 [‐8.27, 3.45]
Analysis 12.1
Comparison 12 Mean blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 12 Mean blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

1

89

Mean Difference (IV, Random, 95% CI)

3.00 [‐5.31, 11.31]
Analysis 12.2
Comparison 12 Mean blood pressure after one hour, Outcome 2 CPAP X SMC.

Comparison 12 Mean blood pressure after one hour, Outcome 2 CPAP X SMC.

3 BILEVEL X SMC Show forest plot

2

167

Mean Difference (IV, Random, 95% CI)

‐5.42 [‐11.60, 0.76]
Analysis 12.3
Comparison 12 Mean blood pressure after one hour, Outcome 3 BILEVEL X SMC.

Comparison 12 Mean blood pressure after one hour, Outcome 3 BILEVEL X SMC.

4 CPAP X BILEVEL Show forest plot

1

80

Mean Difference (IV, Random, 95% CI)

‐4.40 [‐13.25, 4.45]
Analysis 12.4
Comparison 12 Mean blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

Comparison 12 Mean blood pressure after one hour, Outcome 4 CPAP X BILEVEL.
Open in table viewer
Comparison 13. PaO2 (mmHg) after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

4

140

Mean Difference (IV, Random, 95% CI)

10.04 [1.09, 19.00]
Analysis 13.1
Comparison 13 PaO2 (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 13 PaO2 (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

2 CPAP X SMC Show forest plot

5

177

Mean Difference (IV, Random, 95% CI)

‐2.64 [‐25.87, 20.59]
Analysis 13.2
Comparison 13 PaO2 (mmHg) after one hour, Outcome 2 CPAP X SMC.

Comparison 13 PaO2 (mmHg) after one hour, Outcome 2 CPAP X SMC.

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot

3

117

Mean Difference (IV, Random, 95% CI)

‐22.09 [‐34.35, ‐9.83]
Analysis 13.3
Comparison 13 PaO2 (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

Comparison 13 PaO2 (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

4 BILEVEL X SMC Show forest plot

3

79

Mean Difference (IV, Random, 95% CI)

4.79 [‐11.11, 20.69]
Analysis 13.4
Comparison 13 PaO2 (mmHg) after one hour, Outcome 4 BILEVEL X SMC.

Comparison 13 PaO2 (mmHg) after one hour, Outcome 4 BILEVEL X SMC.

5 CPAP X BILEVEL Show forest plot

3

136

Mean Difference (IV, Random, 95% CI)

‐27.00 [‐44.75, ‐9.25]
Analysis 13.5
Comparison 13 PaO2 (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.

Comparison 13 PaO2 (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.

Open in table viewer
Comparison 14. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

15

11329

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.63, 1.16]
Analysis 14.1
Comparison 14 Adverse events, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 14 Adverse events, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

1.1 Skin damage

11

594

Risk Ratio (M‐H, Random, 95% CI)

6.62 [1.20, 36.55]

1.2 Pneumonia

3

232

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

1.3 Pulmonary aspiration

5

1255

Risk Ratio (M‐H, Random, 95% CI)

1.58 [0.06, 38.61]

1.4 Gastrointestinal Bleeding

3

192

Risk Ratio (M‐H, Random, 95% CI)

1.37 [0.27, 6.89]

1.5 Gastric distention

8

484

Risk Ratio (M‐H, Random, 95% CI)

13.26 [0.82, 215.12]

1.6 Vomiting

5

1229

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.46, 2.47]

1.7 Asphyxia

2

170

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

1.8 Pneumothorax

6

1474

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.08, 6.89]

1.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Sinusitis

2

219

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

1.11 Disconfort with mask

7

512

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

1.12 Hypotension

1

1030

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.58, 1.16]

1.13 Arrhythmia

1

1027

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.50, 1.38]

1.14 Progressive respiratory distress

2

1122

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.37, 0.89]

1.15 Cardiorespiratory arrest

3

1252

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.29, 1.26]

1.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

1.17 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.18 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.19 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000 Show forest plot

11

10703

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.63, 1.19]
Analysis 14.2
Comparison 14 Adverse events, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000.

Comparison 14 Adverse events, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000.

2.1 Skin damage

8

492

Risk Ratio (M‐H, Random, 95% CI)

6.62 [1.20, 36.55]

2.2 Pneumonia

2

152

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

2.3 Pulmonary aspiration

2

1095

Risk Ratio (M‐H, Random, 95% CI)

1.58 [0.06, 38.61]

2.4 Gastrointestinal Bleeding

2

170

Risk Ratio (M‐H, Random, 95% CI)

2.32 [0.35, 15.42]

2.5 Gastric distention

4

302

Risk Ratio (M‐H, Random, 95% CI)

13.26 [0.82, 215.12]

2.6 Vomiting

5

1229

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.46, 2.47]

2.7 Asphyxia

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

2.8 Pneumothorax

5

1434

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.08, 6.89]

2.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Sinusitis

2

219

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

2.11 Disconfort with mask

7

512

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

2.12 Hypotension

1

1030

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.58, 1.16]

2.13 Arrhythmia

1

1027

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.50, 1.38]

2.14 Progressive respiratory distress

2

1122

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.37, 0.89]

2.15 Cardiorespiratory arrest

3

1252

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.29, 1.26]

2.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

2.17 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.18 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.19 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

3 CPAP X SMC Show forest plot

10

7133

Risk Ratio (M‐H, Random, 95% CI)

0.63 [0.45, 0.87]
Analysis 14.3
Comparison 14 Adverse events, Outcome 3 CPAP X SMC.

Comparison 14 Adverse events, Outcome 3 CPAP X SMC.

3.1 Skin damage

7

343

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.13, 69.52]

3.2 Pneumonia

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Pulmonary aspiration

5

908

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Gastrointestinal Bleeding

1

22

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.02, 7.39]

3.5 Gastric distention

7

447

Risk Ratio (M‐H, Random, 95% CI)

11.00 [0.64, 189.65]

3.6 Vomiting

3

785

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.34, 2.54]

3.7 Asphyxia

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Pneumothorax

5

998

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Sinusitis

1

89

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Disconfort with mask

3

265

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Hypotension

1

684

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.55, 1.25]

3.13 Arrhythmia

1

682

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.28, 1.09]

3.14 Progressive respiratory distress

2

776

Risk Ratio (M‐H, Random, 95% CI)

0.53 [0.31, 0.92]

3.15 Cardiorespiratory arrest

2

777

Risk Ratio (M‐H, Random, 95% CI)

0.41 [0.18, 0.91]

3.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

4 BILEVEL X SMC Show forest plot

8

6823

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.76, 1.46]
Analysis 14.4
Comparison 14 Adverse events, Outcome 4 BILEVEL X SMC.

Comparison 14 Adverse events, Outcome 4 BILEVEL X SMC.

4.1 Skin damage

6

296

Risk Ratio (M‐H, Random, 95% CI)

7.16 [1.27, 40.50]

4.2 Nosocomial pneumonia

2

152

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

4.3 Disconfort with mask

5

274

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

4.4 Gastrointestinal bleeding

2

170

Risk Ratio (M‐H, Random, 95% CI)

2.32 [0.35, 15.42]

4.5 Gastric dilatation

2

64

Risk Ratio (M‐H, Random, 95% CI)

15.87 [0.96, 262.30]

4.6 Vomiting

5

848

Risk Ratio (M‐H, Random, 95% CI)

1.21 [0.47, 3.11]

4.7 Claustrophobia

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

4.8 Pneumothorax

2

832

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.11, 9.63]

4.9 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Sinusitis

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

4.11 Cardiac arrest

2

830

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.25, 3.61]

4.12 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4.13 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

4.14 Gastric aspiration

1

704

Risk Ratio (M‐H, Random, 95% CI)

3.09 [0.13, 75.50]

4.15 Hypotension

1

698

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.54, 1.23]

4.16 Arrhythmia

1

695

Risk Ratio (M‐H, Random, 95% CI)

1.10 [0.64, 1.90]

4.17 Progressive respiratory distress

1

700

Risk Ratio (M‐H, Random, 95% CI)

0.61 [0.36, 1.03]

5 CPAP X BILEVEL Show forest plot

5

7593

Risk Ratio (M‐H, Random, 95% CI)

1.18 [0.94, 1.48]
Analysis 14.5
Comparison 14 Adverse events, Outcome 5 CPAP X BILEVEL.

Comparison 14 Adverse events, Outcome 5 CPAP X BILEVEL.

5.1 Skin damage

5

790

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.19, 2.16]

5.2 Pneumothorax

2

715

Risk Ratio (M‐H, Random, 95% CI)

2.89 [0.12, 70.63]

5.3 Pulmonary aspiration

3

796

Risk Ratio (M‐H, Random, 95% CI)

2.88 [0.12, 70.43]

5.4 Gastric distension

3

172

Risk Ratio (M‐H, Random, 95% CI)

1.49 [0.56, 4.00]

5.5 Vomiting

4

857

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.43, 2.19]

5.6 Disconfort with mask

4

735

Risk Ratio (M‐H, Random, 95% CI)

1.03 [0.53, 2.00]

5.7 Increased breathing discomfort

1

576

Risk Ratio (M‐H, Random, 95% CI)

1.42 [0.67, 3.02]

5.8 Hypotension

2

758

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.65, 1.48]

5.9 Arrhythmia

1

677

Risk Ratio (M‐H, Random, 95% CI)

2.00 [1.02, 3.92]

5.10 Progressive respiratory distress

1

679

Risk Ratio (M‐H, Random, 95% CI)

1.19 [0.64, 2.21]

5.11 Cardiorespiratory arrest

1

678

Risk Ratio (M‐H, Random, 95% CI)

1.61 [0.59, 4.38]

5.12 Pharyngeal damage

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.06, 14.69]

5.13 Cough

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.32 [0.01, 7.57]
Open in table viewer
Comparison 15. Hospital or 7‐day mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

21

2263

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.55, 0.94]
Analysis 15.1
Comparison 15 Hospital or 7‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 15 Hospital or 7‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
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Comparison 16. Hospital or 30‐day mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

22

2387

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.60, 0.95]
Analysis 16.1
Comparison 16 Hospital or 30‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 16 Hospital or 30‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
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Comparison 17. General or 7‐day ETI rate

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

23

2417

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.38, 0.78]
Analysis 17.1
Comparison 17 General or 7‐day ETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

Comparison 17 General or 7‐day ETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

QUOROM statement flow diagram of 2005
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Figure 1

QUOROM statement flow diagram of 2005

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Figure 4. PRISMA statement flow diagram of 2011
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Figure 2

Figure 4. PRISMA statement flow diagram of 2011

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Funnel plot of comparison: 1 Hospital Mortality, outcome: 1.1 NPPV (CPAP and BILEVEL) x SMC.
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Figure 5

Funnel plot of comparison: 1 Hospital Mortality, outcome: 1.1 NPPV (CPAP and BILEVEL) x SMC.

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Cumulative meta‐analysis
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Figure 6

Cumulative meta‐analysis

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Comparison 1 Hospital mortality, Outcome 1 NPPV (CPAP and BILEVEL) x SMC.
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Analysis 1.1

Comparison 1 Hospital mortality, Outcome 1 NPPV (CPAP and BILEVEL) x SMC.

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Comparison 1 Hospital mortality, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.
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Analysis 1.2

Comparison 1 Hospital mortality, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

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Comparison 1 Hospital mortality, Outcome 3 NPPV (CPAP and BILEVEL) X SMC‐ ED place.
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Analysis 1.3

Comparison 1 Hospital mortality, Outcome 3 NPPV (CPAP and BILEVEL) X SMC‐ ED place.

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Comparison 1 Hospital mortality, Outcome 4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place.
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Analysis 1.4

Comparison 1 Hospital mortality, Outcome 4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place.

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Comparison 1 Hospital mortality, Outcome 5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline.
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Analysis 1.5

Comparison 1 Hospital mortality, Outcome 5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline.

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Comparison 1 Hospital mortality, Outcome 6 CPAP x SMC.
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Analysis 1.6

Comparison 1 Hospital mortality, Outcome 6 CPAP x SMC.

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Comparison 1 Hospital mortality, Outcome 7 CPAP X SMC ‐ sensitivity analysis.
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Analysis 1.7

Comparison 1 Hospital mortality, Outcome 7 CPAP X SMC ‐ sensitivity analysis.

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Comparison 1 Hospital mortality, Outcome 8 BILEVEL X SMC.
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Analysis 1.8

Comparison 1 Hospital mortality, Outcome 8 BILEVEL X SMC.

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Comparison 1 Hospital mortality, Outcome 9 BILEVEL X SMC ‐ sensitivity analysis.
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Analysis 1.9

Comparison 1 Hospital mortality, Outcome 9 BILEVEL X SMC ‐ sensitivity analysis.

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Comparison 1 Hospital mortality, Outcome 10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline.
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Analysis 1.10

Comparison 1 Hospital mortality, Outcome 10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline.

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Comparison 1 Hospital mortality, Outcome 11 BILEVEL X SMC ‐ in patients hypercanics.
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Analysis 1.11

Comparison 1 Hospital mortality, Outcome 11 BILEVEL X SMC ‐ in patients hypercanics.

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Comparison 1 Hospital mortality, Outcome 12 CPAP X BILEVEL.
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Analysis 1.12

Comparison 1 Hospital mortality, Outcome 12 CPAP X BILEVEL.

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Comparison 1 Hospital mortality, Outcome 13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline.
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Analysis 1.13

Comparison 1 Hospital mortality, Outcome 13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline.

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Comparison 1 Hospital mortality, Outcome 14 CPAP X BILEVEL ‐ in patients hypercanics.
Figures and Tables -
Analysis 1.14

Comparison 1 Hospital mortality, Outcome 14 CPAP X BILEVEL ‐ in patients hypercanics.

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Comparison 2 EETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 2.1

Comparison 2 EETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 2 EETI rate, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.
Figures and Tables -
Analysis 2.2

Comparison 2 EETI rate, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis.

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Comparison 2 EETI rate, Outcome 3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline.
Figures and Tables -
Analysis 2.3

Comparison 2 EETI rate, Outcome 3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline.

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Comparison 2 EETI rate, Outcome 4 CPAP X SMC.
Figures and Tables -
Analysis 2.4

Comparison 2 EETI rate, Outcome 4 CPAP X SMC.

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Comparison 2 EETI rate, Outcome 5 CPAP X SMC ‐ sensitivity analysis.
Figures and Tables -
Analysis 2.5

Comparison 2 EETI rate, Outcome 5 CPAP X SMC ‐ sensitivity analysis.

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Comparison 2 EETI rate, Outcome 6 BILEVEL X SMC.
Figures and Tables -
Analysis 2.6

Comparison 2 EETI rate, Outcome 6 BILEVEL X SMC.

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Comparison 2 EETI rate, Outcome 7 BILEVEL X SMC ‐ sensitivity analysis.
Figures and Tables -
Analysis 2.7

Comparison 2 EETI rate, Outcome 7 BILEVEL X SMC ‐ sensitivity analysis.

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Comparison 2 EETI rate, Outcome 8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline.
Figures and Tables -
Analysis 2.8

Comparison 2 EETI rate, Outcome 8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline.

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Comparison 2 EETI rate, Outcome 9 BILEVEL X SMC ‐ in patients hypercapnics.
Figures and Tables -
Analysis 2.9

Comparison 2 EETI rate, Outcome 9 BILEVEL X SMC ‐ in patients hypercapnics.

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Comparison 2 EETI rate, Outcome 10 CPAP X BILEVEL.
Figures and Tables -
Analysis 2.10

Comparison 2 EETI rate, Outcome 10 CPAP X BILEVEL.

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Comparison 2 EETI rate, Outcome 11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline.
Figures and Tables -
Analysis 2.11

Comparison 2 EETI rate, Outcome 11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline.

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Comparison 2 EETI rate, Outcome 12 CPAP X BILEVEL ‐ in patients hypercapnics.
Figures and Tables -
Analysis 2.12

Comparison 2 EETI rate, Outcome 12 CPAP X BILEVEL ‐ in patients hypercapnics.

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Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 3.1

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 3.2

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 2 CPAP X SMC.

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Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 3.3

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 3 BILEVEL X SMC.

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Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 3.4

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 4 CPAP X BILEVEL.

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Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 5 BILEVEL X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 3.5

Comparison 3 Incidence of acute myocardial infarction (during intervention), Outcome 5 BILEVEL X SMC ‐ heterogeneity analysis.

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Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 4.1

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 4.2

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 2 CPAP X SMC.

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Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 4.3

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 3 BILEVEL X SMC.

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Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 4.4

Comparison 4 Incidence of acute myocardial infarction (after intervention), Outcome 4 CPAP X BILEVEL.

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Comparison 5 Intolerance to allocated treatment, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 5.1

Comparison 5 Intolerance to allocated treatment, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 5 Intolerance to allocated treatment, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 5.2

Comparison 5 Intolerance to allocated treatment, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Comparison 5 Intolerance to allocated treatment, Outcome 3 CPAP X SMC.
Figures and Tables -
Analysis 5.3

Comparison 5 Intolerance to allocated treatment, Outcome 3 CPAP X SMC.

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Comparison 5 Intolerance to allocated treatment, Outcome 4 BILEVEL X SMC.
Figures and Tables -
Analysis 5.4

Comparison 5 Intolerance to allocated treatment, Outcome 4 BILEVEL X SMC.

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Comparison 5 Intolerance to allocated treatment, Outcome 5 CPAP X BILEVEL.
Figures and Tables -
Analysis 5.5

Comparison 5 Intolerance to allocated treatment, Outcome 5 CPAP X BILEVEL.

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Comparison 6 Hospital length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 6.1

Comparison 6 Hospital length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 6 Hospital length of stay, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 6.2

Comparison 6 Hospital length of stay, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Comparison 6 Hospital length of stay, Outcome 3 CPAP X SMC.
Figures and Tables -
Analysis 6.3

Comparison 6 Hospital length of stay, Outcome 3 CPAP X SMC.

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Comparison 6 Hospital length of stay, Outcome 4 BILEVEL X SMC.
Figures and Tables -
Analysis 6.4

Comparison 6 Hospital length of stay, Outcome 4 BILEVEL X SMC.

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Comparison 6 Hospital length of stay, Outcome 5 CPAP X BILEVEL.
Figures and Tables -
Analysis 6.5

Comparison 6 Hospital length of stay, Outcome 5 CPAP X BILEVEL.

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Comparison 7 ICU length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 7.1

Comparison 7 ICU length of stay, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 7 ICU length of stay, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 7.2

Comparison 7 ICU length of stay, Outcome 2 CPAP X SMC.

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Comparison 7 ICU length of stay, Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 7.3

Comparison 7 ICU length of stay, Outcome 3 BILEVEL X SMC.

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Comparison 7 ICU length of stay, Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 7.4

Comparison 7 ICU length of stay, Outcome 4 CPAP X BILEVEL.

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Comparison 8 Breath rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 8.1

Comparison 8 Breath rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 8 Breath rate after one hour, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 8.2

Comparison 8 Breath rate after one hour, Outcome 2 CPAP X SMC.

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Comparison 8 Breath rate after one hour, Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 8.3

Comparison 8 Breath rate after one hour, Outcome 3 BILEVEL X SMC.

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Comparison 8 Breath rate after one hour, Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 8.4

Comparison 8 Breath rate after one hour, Outcome 4 CPAP X BILEVEL.

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Comparison 9 Heart rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 9.1

Comparison 9 Heart rate after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 9 Heart rate after one hour, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 9.2

Comparison 9 Heart rate after one hour, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis.

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Comparison 9 Heart rate after one hour, Outcome 3 CPAP X SMC.
Figures and Tables -
Analysis 9.3

Comparison 9 Heart rate after one hour, Outcome 3 CPAP X SMC.

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Comparison 9 Heart rate after one hour, Outcome 4 CPAP X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 9.4

Comparison 9 Heart rate after one hour, Outcome 4 CPAP X SMC ‐ heterogeneity analysis.

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Comparison 9 Heart rate after one hour, Outcome 5 BILEVEL X SMC.
Figures and Tables -
Analysis 9.5

Comparison 9 Heart rate after one hour, Outcome 5 BILEVEL X SMC.

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Comparison 9 Heart rate after one hour, Outcome 6 CPAP X BILEVEL.
Figures and Tables -
Analysis 9.6

Comparison 9 Heart rate after one hour, Outcome 6 CPAP X BILEVEL.

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Comparison 10 Sistolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 10.1

Comparison 10 Sistolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 10 Sistolic blood pressure after one hour, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 10.2

Comparison 10 Sistolic blood pressure after one hour, Outcome 2 CPAP X SMC.

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Comparison 10 Sistolic blood pressure after one hour, Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 10.3

Comparison 10 Sistolic blood pressure after one hour, Outcome 3 BILEVEL X SMC.

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Comparison 10 Sistolic blood pressure after one hour, Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 10.4

Comparison 10 Sistolic blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

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Comparison 10 Sistolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL ‐ heterogeneity analysis.
Figures and Tables -
Analysis 10.5

Comparison 10 Sistolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL ‐ heterogeneity analysis.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 11.1

Comparison 11 Diastolic blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 11.2

Comparison 11 Diastolic blood pressure after one hour, Outcome 2 CPAP X SMC.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 11.3

Comparison 11 Diastolic blood pressure after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 4 BILEVEL X SMC.
Figures and Tables -
Analysis 11.4

Comparison 11 Diastolic blood pressure after one hour, Outcome 4 BILEVEL X SMC.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL.
Figures and Tables -
Analysis 11.5

Comparison 11 Diastolic blood pressure after one hour, Outcome 5 CPAP X BILEVEL.

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Comparison 11 Diastolic blood pressure after one hour, Outcome 6 CPAP X BILEVEL ‐ heterogeneity analysis.
Figures and Tables -
Analysis 11.6

Comparison 11 Diastolic blood pressure after one hour, Outcome 6 CPAP X BILEVEL ‐ heterogeneity analysis.

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Comparison 12 Mean blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 12.1

Comparison 12 Mean blood pressure after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 12 Mean blood pressure after one hour, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 12.2

Comparison 12 Mean blood pressure after one hour, Outcome 2 CPAP X SMC.

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Comparison 12 Mean blood pressure after one hour, Outcome 3 BILEVEL X SMC.
Figures and Tables -
Analysis 12.3

Comparison 12 Mean blood pressure after one hour, Outcome 3 BILEVEL X SMC.

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Comparison 12 Mean blood pressure after one hour, Outcome 4 CPAP X BILEVEL.
Figures and Tables -
Analysis 12.4

Comparison 12 Mean blood pressure after one hour, Outcome 4 CPAP X BILEVEL.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 13.1

Comparison 13 PaO2 (mmHg) after one hour, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 2 CPAP X SMC.
Figures and Tables -
Analysis 13.2

Comparison 13 PaO2 (mmHg) after one hour, Outcome 2 CPAP X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.
Figures and Tables -
Analysis 13.3

Comparison 13 PaO2 (mmHg) after one hour, Outcome 3 CPAP X SMC ‐ heterogeneity analysis.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 4 BILEVEL X SMC.
Figures and Tables -
Analysis 13.4

Comparison 13 PaO2 (mmHg) after one hour, Outcome 4 BILEVEL X SMC.

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Comparison 13 PaO2 (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.
Figures and Tables -
Analysis 13.5

Comparison 13 PaO2 (mmHg) after one hour, Outcome 5 CPAP X BILEVEL.

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Comparison 14 Adverse events, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
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Analysis 14.1

Comparison 14 Adverse events, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 14 Adverse events, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000.
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Analysis 14.2

Comparison 14 Adverse events, Outcome 2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000.

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Comparison 14 Adverse events, Outcome 3 CPAP X SMC.
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Analysis 14.3

Comparison 14 Adverse events, Outcome 3 CPAP X SMC.

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Comparison 14 Adverse events, Outcome 4 BILEVEL X SMC.
Figures and Tables -
Analysis 14.4

Comparison 14 Adverse events, Outcome 4 BILEVEL X SMC.

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Comparison 14 Adverse events, Outcome 5 CPAP X BILEVEL.
Figures and Tables -
Analysis 14.5

Comparison 14 Adverse events, Outcome 5 CPAP X BILEVEL.

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Comparison 15 Hospital or 7‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 15.1

Comparison 15 Hospital or 7‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 16 Hospital or 30‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
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Analysis 16.1

Comparison 16 Hospital or 30‐day mortality, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Comparison 17 General or 7‐day ETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.
Figures and Tables -
Analysis 17.1

Comparison 17 General or 7‐day ETI rate, Outcome 1 NPPV (CPAP and BILEVEL) X SMC.

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Summary of findings for the main comparison. Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary edema

Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary oedema

Patient or population: patients with cardiogenic pulmonary oedema
Settings: Emergency Department or Intensive Care Unit
Intervention: Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV)

Hospital mortalityY

Study population1

RR 0.66
(0.48 to 0.89)

1107
(20 studies)

⊕⊕⊕⊕
high2,3

204 per 1000

135 per 1000
(98 to 182)

Moderate1

200 per 1000

132 per 1000
(96 to 178)

Endotracheal intubation rate

Study population

RR 0.52
(0.36 to 0.75)

1261
(22 studies)

⊕⊕⊝⊝
low4,5

249 per 1000

130 per 1000
(90 to 187)

Moderate

300 per 1000

156 per 1000
(108 to 225)

Incidence of acute myocardial infarction (During intervention)

Study population

RR 1.24
(0.79 to 1.95)

461
(8 studies)

⊕⊕⊕⊝
moderate5,6

153 per 1000

190 per 1000
(121 to 299)

Moderate

169 per 1000

210 per 1000
(134 to 330)

Incidence of acute myocardial infarction (After intervention)

Study population

RR 0.7
(0.11 to 4.26)

154
(4 studies)

⊕⊝⊝⊝
very low5,7

26 per 1000

18 per 1000
(3 to 111)

Moderate

13 per 1000

9 per 1000
(1 to 55)

Intolerance to allocated treatment

Study population

RR 0.47
(0.29 to 0.77)

1848
(13 studies)

⊕⊕⊕⊝
moderate8,9,10

234 per 1000

110 per 1000
(68 to 180)

Moderate

350 per 1000

165 per 1000
(101 to 269)

Hospital length of stay

The mean hospital length of stay in the intervention groups was
0.8 lower
(2.1 lower to 0.51 higher)

542
(10 studies)

⊕⊝⊝⊝
very low11,12

Intensive care unit length of stay (Copy)

The mean intensive care unit length of stay (copy) in the intervention groups was
0.89 lower
(1.33 to 0.45 lower)

222
(6 studies)

⊕⊕⊝⊝
low5,13

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 The most studies have mixed populations (with different levels of severity and co‐morbidities).
2 Was included only two quasi‐randomised trials, but sensitivity analysis with quasi‐randomised studies exclusion (Bersten 1991; Weitz 2007), showed the results to remain statistically significant. L'Her 2004 was interrupted early due to a greater number in deaths and complications in the control group.
3 Although there is less 300 events in meta‐analysis, when add Gray's study that analysed the mortality in 30 days, our meta‐analysis of hospital mortality show that these study reinforce the favourable use of NPPV in ACPE with more 300 events.
4 Was included only two quasi‐randomised trials, but sensitivity analysis with quasi‐randomised studies exclusion (Bersten 1991; Weitz 2007), showed the results to remain statistically significant. Park 2004 was interrupted early due to a difference in the frequency of intubations. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention.
5 There is less 300 events in meta‐analysis.
6 Although two studies (Sharon 2000; Thys 2002) were interrupted early due to the incidence of acute myocardial infarction and the second due to a batch of failures of treatment and clinical decline.
7 Was included one quasi‐randomised trial (Weitz 2007). Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention.
8 Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). L'Her 2004 was interrupted early due to a greater number in deaths and complications in the control group and not present the results in relation to autonomy for the activities of daily living, patient comfort and some planned adverse effects to be observed. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention. Thys 2002 was interrupted early due to a batch of failures of treatment and clinical decline.
9 The grouping of the studies demonstrated relevant heterogeneity which was eliminated with the exclusion of Gray 2008 study, but we have not found plausible justification for this result
10 RR < 0.5
11 Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). L'Her 2004 and Thys 2002 were interrupted early, the first due to a greater number in deaths and in the control group and the second due to a batch of failures of treatment and clinical decline. L'Her 2004 did not present the results in relation to autonomy for the activities of daily living, patient comfort and some planned adverse effects to be observed. Lin 1991 lost 35 of the 80 (44%) randomised patients for having fulfilled the criteria of exclusion or having presented failures on the received intervention.
12 The grouping of the studies demonstrated relevant heterogeneity.
13 Was included two quasi‐randomised trials (Bersten 1991; Weitz 2007). Thys 2002 was interrupted early due to a batch of failures of treatment and clinical decline.

Figures and Tables -
Summary of findings for the main comparison. Non‐invasive positive pressure ventilation (CPAP and bilevel NPPV) for cardiogenic pulmonary edema
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Table 1. IPAP Level and EPAP Level and time of intervention

Study

IPAP level

(cmH2O)

EPAP in bievel NPPV

(cmH2O)

PEEP in CPAP (cmH2O)

Time of bilevel NPPV

(hours)

Time of CPAP

(hours)

Bautin 2005

5.1 (SD 0.3)

9.8 (SD 1.1)

Bellone 2004

5

10

1.6 (SD 0.6)

1.7 (SD 0.7)

Bellone 2005

5

10

3.41 (SD 1.1)

3.6 (SD 1.3)

Bersten 1991

10

9.3 (SD 4.9)

Crane 2004

15

5

10

Ferrari 2007

15 (SD 3.1)

7 (SD 1.2)

8.8 (SD 1.9)

6.0 (SD 4.7)

8.1 (SD 8.3)

Ferrari 2009

14 (SD 3.1)

6.7 (SD 1.4)

8.8 (SD 1.7)

5.9 (SD 4.0)

8.4 (SD 7.1)

Fontanella 2010

18 (SD 3)

10 (SD 2)

8 (SD 2)

Frontin 2010

10

Gray 2009

14 (SD 5)

7 (SD 3)

10 (SD 4)

2.0 (SD 1.3)

2.2 (SD 1.5)

Kelly 2002

7.5

L'Her 2004

7.5

8 (SD 6)

Liesching 2003

12

4

10

Martin‐Bermudez 2002

1.3 (SD 0.8)

1.8 (SD 1)

Masip 2000

15.2 (SD 2.4)

5

4.2 (SD 1.5)

Mehta 1997

14.35 (SD 1.73)

5

10.08 (SD 1.24)

7.1 (SD 4.7)

6.4 (SD 5.8)

Moritz 2007

12 (SD 3.2)

4.9 (SD 0.9)

7.7 (SD 2.1)

2.8

2.3

Nava 2003

14.5 (SD 21.1)

6.1 (SD 3.2)

11.4 (SD 3.6)

Park 2001

12

4

7.5

2.5 (SD 0.6)

2.8 (SD 1.5)

Park 2004

17 (SD 2)

11 (SD 2)

11 (SD 2)

2.0 (SD 1.0)

1.7 (SD 0.6)

Rasanen 1985

10

Sharon 2000

9.3 (SD 2.3)

4.2 (SD 3.1)

Takeda 1997

11.9 (SD 8.4)

Thys 2002

16.5 (SD 3.3)

6.1 (SD 1.5)

1.2 (SD 0.2)

Weitz 2007

12.5 (SD 1.2)

5

CPAP ‐ continuous positive airway pressure; EPAP ‐ expiratory positive airway pressure; IPAP ‐ inspiratory positive airway pressure; PEEP ‐ positive expiratory end pressure; SD ‐ standard deviation; * statistically significant.

Figures and Tables -
Table 1. IPAP Level and EPAP Level and time of intervention
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Table 2. Summary of adverse events

Adverse events

Number of events (CPAP)

Total number CPAP

Number of event (bilevel NPPV)

Total number (bilevel NPPV)

RR (95% CI)

Skin damage

2

472

17

458

0.06 (0.01, 0.43)*

Pneumonia

0

40

1

76

0.63 (0.03, 15.03)

Pulmonary aspiration

0

476

1

383

0.27 (0.01, 6.57)

Gastric distention

5

178

8

51

0.18 (0.06, 0.52)*

GI bleeding

0

11

3

85

1.02 (0.06, 18.63)

Vomitting

7

381

9

419

0.86 (0.32, 2.27)

Pneumothorax

0

440

1

430

0.33 (0.01, 7.97)

Asphyxia/claustrophobia

0

20

1

65

1.05 (0.04, 24.76)

Mask discomfort

15

364

22

440

0.82 (0.43, 1.57)

Sinusitis

0

43

1

65

0.50 (0.02, 12.00)

Conjunctivitis

0

70

Eye irritation

0

20

Cardiac arrest

6

333

13

410

0.57 (0.22, 1.48)

Stroke

0

65

Seizure

0

65

Hypotension

36

332

37

346

1.01 (0.66, 1.56)

Arrhythmia requiring treatment

12

332

25

345

0.50 (0.25, 0.98)*

Progressive respiratory distress

17

333

21

346

0.84 (0.45, 1.57)

Increase breathing discomfort

16

287

19

291

0.85 (0.45, 1.63)

CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; RR ‐ relative risk; SD ‐ standard deviation; * statistically significant..

Figures and Tables -
Table 2. Summary of adverse events
Navigate to table in Review
Table 3. Adverse events by NPPV versus SMC

Adverse events

Studies

NPPV group

SMC group

RR (95% CI)

Skin damage

11 studies (Rasanen 1985, Bersten 1991, Takeda 1998, Masip 2000, Kelly 2002, Thys 2002, Nava 2003, Crane 2004, L'Her 2004, Park 2004, Bautin 2005)

17/318

0/276

6.62 (1.20, 36.55)*

Pneumonia

3 study (Lin 1991, Nava 2003, Bautin 2005)

1/116

4/116

0.35 (0.05, 2.20)

Pulmonary aspiration

5 studies (Rasanen 1985, Bersten 1991, Lin 1991, Kelly 2002, Gray 2008)

1/787

0/468

1.58 (0.06, 38,61)

Gastrointestinal
bleeding

3 study (Takeda 1998, Masip 2000, Nava 2003)

3/96

2/96

1,37 (0.27, 6.89)

Gastric distension

8 studies (Rasanen 1985, Bersten 1991, Lin 1991, Takeda 1998, Thys 2002, Park 2004, L'Her 2004, Frotin 2010)

13/253

0/231

13.26 ( 0.82, 215.12)

Vomiting

5 studies (Masip 2000, Thys 2002, Crane 2004, Park 2004, Gray 2008)

16/800

8/429

1.06 (0.46, 2.47)

Asphyxia

2 study (Bersten 1991, Nava 2003)

1/85

0/85

3.00 (0.12, 72.31)

Pneumothorax

6 studies (Bersten 1991, Kelly 2002, Nava 2003, L'Her 2004, Gray 2008, Frotin 2010)

1/894

1/580

0.72 (0.08, 6.89)

Conjunctivitis

2 studies (Kelly 2002, L'Her 2004)

0/70

0/77

inestimable

Sinusitis

2 study (Nava 2003, L'Her 2004)

1/108

0/111

3.00 (0.12, 72.31)

Mask discomfort

7 study (Masip 2000, Nava 2003, L'Her 2004, Park 2004, Bautin 2005, Weitz 2007, Frotin 2010)

7/265

0/247

5.39 (0.97, 30.09)

Hypotension

1 study (Gray 2008)

73/678

46/352

0.82 (0.58, 1.16)

Arrhythmia

1 study (Gray 2008)

37/677

23/350

0.83 (0.50, 1.38)

Progressive respiratory distress

2 studies (L'Her 2004, Gray 2008)

39/722

36/400

0.58 (0.37, 0.89)*

Neurological failure (coma)

1 study (L'Her 2004)

1/44

11/46

0,10 (0.01, 0,71)*

Cardiorespiratory arrest

3 studies (Nava 2003, L'Her 2004, Gray 2008)

21/786

22/466

0.60 (0.29, 1.26)

Eye irritation

1 study (Masip 2000)

0/20

0/20

inestimable

Stroke

1 study (Nava 2003)

0/65

0/65

inestimable

Seizure

1 study (Nava 2003)

0/65

1/65

0.33 (0.01, 8.03)

CI ‐ confidence interval; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Figures and Tables -
Table 3. Adverse events by NPPV versus SMC
Navigate to table in Review
Table 4. Adverse events by CPAP versus SMC

Adverse Events

Studies

CPAP group

SMC group

RR (95% CI)

Skin damage

7 studies (Rasanen 1985, Bersten 1991, Takeda 1998,

Kelly 2002, Crane 2004, L'Her 2004, and Park 2004)

1/168

0/175

3.00 (0.13, 69.52)

Pneumonia

1 study (Lin 1991)

0/40

0/40

inestimable

Pulmonary aspiration

5 studies (Rasanen 1985, Bersten 1991, Lin 1991,

Kelly 2002, Gray 2008)

0/440

0/468

inestimable

Gastrointestinal
bleeding

1 study (Takeda 1998)

0/11

1/11

0.33 (0.02,7.39)

Gastric distension

7 studies (Rasanen 1985, Bersten 1991, Lin 1991,

Takeda 1998, Park 2004, L'Her 2004, Frotin 2010)

5/221

0/226

11.00 ( 0.64, 189.65)

Vomiting

3 studies (Crane 2004, Park 2004, Gray 2008)

7/381

8/404

0.93 (0.34, 2.54)

Asphyxia

1 study (Bersten 1991)

0/20

0/20

inestimable

Pneumothorax

5 studies (Bersten 1991, Kelly 2002, L'Her 2004,

Gray 2008, Frotin 2010)

0/483

0/515

inestimable

Conjunctivitis

2 studies (Kelly 2002, L'Her 2004)

0/70

0/77

inestimable

Sinusitis

1 study (L'Her 2004)

0/43

0/46

inestimable

Mask discomfort

3 studies (L'Her 2004, Park 2004, Frotin 2010)

0/130

0/135

inestimable

Hypotension

1 study (Gray 2008)

36/332

46/352

0.83 (0.55, 1.25)

Arrhythmia

1 study (Gray 2008)

12/332

23/350

0.55 (0.28, 1.09)

Progressive respiratory distress

2 studies (L'Her 2004, Gray 2008)

18/376

36/400

0.53 (0.31, 0.92)*

Neurological failure (coma)

1 study (L'Her 2004)

1/44

11/46

0,10 (0.01, 0,71)*

Cardiorespiratory arrest

2 studies (L'Her 2004, Gray 2008)

8/376

21/401

0.41 (0.18, 0.91)*

CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Figures and Tables -
Table 4. Adverse events by CPAP versus SMC
Navigate to table in Review
Table 5. Adverse events by bilevel NPPV versus SMC

Adverse Events

Studies

Bilevel NPPV Group

SMC Group

RR (95% CI)

Skin damage

6 studies (Masip 2000, Thys 2002, Nava 2003, Crane 2004, Park 2004, Bautin 2005)

16/148

0/148

7.16 (1.27, 40.50)*

Pneumonia

2 study (Nava 2003, Bautin 2005)

1/76

4/76

0.35 (0.05, 2.20)

Gastrointestinal
bleeding

2 studies (Nava 2003, Masip 2000)

3/85

1/85

2.32 (0.35, 15.42)

Gastric distension

2 studies (Thys 2002, Park 2004)

8/32

0/32

15.87 (0.96, 262.30)

Vomiting

5 studies (Masip 2000, Thys 2002, Crane 2004, Park 2004, Gray 2008)

9/419

8/429

1.21 (0.47, 3.11)

Pneumothorax

2 study (Nava 2003, Gray 2008)

1/411

1/421

1.01 (0.11, 9.63)

Eye irritation

1 study (Masip 2000)

0/20

0/20

inestimable

Sinusitis

1 study (Nava 2003)

1/65

0/65

3.00 (0.12, 72.31)

Mask discomfort

5 studies (Masip 2000, Nava 2003, Park 2004, Bautin 2005, Weitz 2007)

7/135

0/139

5.39 (0.97, 30.09)

Claustrophobia

1 study (Nava 2003)

1/65

0/65

3.00 (0.12, 72.31)

Cardiac arrest

2 study (Nava 2003, Gray 2008)

13/410

17/420

0.96 (0.25, 3.61)

Stroke

1 study (Nava 2003)

0/65

0/65

inestimable

Seizure

1 study (Nava 2003)

0/65

1/65

0.33 (0.01, 8.03)

Pulmonary aspiration

1 studies (Gray 2008)

1/347

0/357

3.09 (0.13, 75.50)

Hypotension

1 study (Gray 2008)

37/346

46/352

0.82 (0.54, 1.23)

Arrhythmia

1 study (Gray 2008)

25/345

23/350

1.10 (0.64, 1.90)

Progressive respiratory distress

1 study (Gray 2008)

21/346

35/354

0.61 (0.36, 1.03)

CI ‐ confidence interval; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Figures and Tables -
Table 5. Adverse events by bilevel NPPV versus SMC
Navigate to table in Review
Table 6. Adverse events by bilevel NPPV versus CPAP

Adverse events

Sstudies

Bilevel NPPV group

CPAP group

RR (95% CI)

Skin damage

5 studies (Mehta 1997, Martin‐Bermudez 2002, Crane 2004, Park 2004, Gray 2008)

4/400

6/390

0.64 (0.19, 2.16)

Pulmonary aspiration

3 studies (Mehta 1997, Martin‐Bermudez 2002, Gray 2008)

1/407

0/389

2.88 (0.12, 70.43)

Gastric distension

3 studies (Mehta 1997, Martin‐Bermudez 2002, Park 2004)

8/89

5/83

1.49 (0.56, 4.00)

Vomiting

4 studies (Martin‐Bermudez 2002, Crane 2004, Park 2004, Gray 2008)

11/437

11/420

0.97 (0.43, 2.19)

Pneumothorax

2 studies (Mehta 1997, Gray 2008)

1/365

0/350

2.89 (0.12, 70.63)

Mask discomfort

4 studies (Mehta 1997, Martin‐Bermudez 2002, Park 2004, Gray 2008)

17/375

16/360

1.03 (0.53, 2.00)

Increased breathing discomfort

1 study (Gray 2008)

16/291

11/285

1.42 (0.67, 3.02)

Hypotension

2 studies (Martin‐Bermudez 2002, Gray 2008)

41/387

40/371

0.98 (0.65, 1.48)

Arrhythmia

1 study (Gray 2008)

25/345

12/332

2.00 (1.02, 3.92)*

Progressive respiratory distress

1 study (Gray 2008)

21/346

17/333

1.19 (0.64, 2.21)

Cardiorespiratory arrest

1 study (Gray 2008)

10/345

6/333

1.61 (0.59, 4.38)

Pharyngeal damage

1 study (Martin‐Bermudez 2002)

1/41

1/39

0.95 (0.06, 14.69)

Cough

1 study (Martin‐Bermudez 2002)

1/41

1/39

0.32 (0.01, 7.57)

CI ‐ confidence interval; CPAP ‐ continuous positive airway pressure; NPPV ‐ noninvasive positive pressure ventilation; RR ‐ relative risk; SMC ‐ standard medical care; * statistically significant.

Figures and Tables -
Table 6. Adverse events by bilevel NPPV versus CPAP
Navigate to table in Review
Comparison 1. Hospital mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) x SMC Show forest plot

20

1107

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.48, 0.89]

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot

18

1023

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.46, 0.91]

3 NPPV (CPAP and BILEVEL) X SMC‐ ED place Show forest plot

9

717

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.36, 0.86]

4 NPPV (CPAP and BILEVEL) X SMC ‐ ICU place Show forest plot

7

365

Risk Ratio (M‐H, Random, 95% CI)

0.48 [0.28, 0.83]

5 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercanics ‐ baseline Show forest plot

9

603

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.40, 0.88]

6 CPAP x SMC Show forest plot

13

699

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.39, 0.94]

7 CPAP X SMC ‐ sensitivity analysis Show forest plot

12

659

Risk Difference (M‐H, Random, 95% CI)

‐0.12 [‐0.19, ‐0.04]

8 BILEVEL X SMC Show forest plot

11

506

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.39, 1.09]

9 BILEVEL X SMC ‐ sensitivity analysis Show forest plot

9

458

Risk Ratio (M‐H, Random, 95% CI)

0.63 [0.37, 1.09]

10 BILEVEL X SMC ‐ in patients hypercanics ‐ baseline Show forest plot

7

401

Risk Ratio (M‐H, Random, 95% CI)

0.59 [0.34, 1.02]

11 BILEVEL X SMC ‐ in patients hypercanics Show forest plot

2

104

Risk Ratio (M‐H, Random, 95% CI)

0.20 [0.04, 0.86]

12 CPAP X BILEVEL Show forest plot

12

694

Risk Ratio (M‐H, Random, 95% CI)

1.10 [0.61, 1.97]

13 CPAP X BILEVEL ‐ in patients hypercanics ‐ baseline Show forest plot

9

518

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.45, 2.14]

14 CPAP X BILEVEL ‐ in patients hypercanics Show forest plot

2

98

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.33, 3.37]
Figures and Tables -
Comparison 1. Hospital mortality
Navigate to table in Review
Comparison 2. EETI rate

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

22

1261

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.36, 0.75]

2 NPPV (CPAP and BILEVEL) X SMC ‐ sensitivity analysis Show forest plot

20

1195

Risk Ratio (M‐H, Random, 95% CI)

0.53 [0.37, 0.78]

3 NPPV (CPAP and BILEVEL) X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot

9

621

Risk Ratio (M‐H, Random, 95% CI)

0.44 [0.25, 0.77]

4 CPAP X SMC Show forest plot

14

825

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.33, 0.67]

5 CPAP X SMC ‐ sensitivity analysis Show forest plot

13

785

Risk Ratio (M‐H, Random, 95% CI)

0.48 [0.34, 0.67]

6 BILEVEL X SMC Show forest plot

12

536

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.26, 1.17]

7 BILEVEL X SMC ‐ sensitivity analysis Show forest plot

10

470

Risk Ratio (M‐H, Random, 95% CI)

0.45 [0.26, 0.80]

8 BILEVEL X SMC ‐ in patients hypercapnics ‐ baseline Show forest plot

7

401

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.22, 0.97]

9 BILEVEL X SMC ‐ in patients hypercapnics Show forest plot

3

120

Risk Ratio (M‐H, Random, 95% CI)

0.28 [0.12, 0.69]

10 CPAP X BILEVEL Show forest plot

13

721

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.55, 1.97]

11 CPAP X BILEVEL ‐ in patients hypercapnics ‐ baseline Show forest plot

9

518

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.58, 2.33]

12 CPAP X BILEVEL ‐ in patients hypercapnics Show forest plot

2

98

Risk Ratio (M‐H, Random, 95% CI)

0.92 [0.26, 3.21]
Figures and Tables -
Comparison 2. EETI rate
Navigate to table in Review
Comparison 3. Incidence of acute myocardial infarction (during intervention)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

8

461

Risk Ratio (M‐H, Random, 95% CI)

1.24 [0.79, 1.95]

2 CPAP X SMC Show forest plot

3

152

Risk Ratio (M‐H, Random, 95% CI)

0.91 [0.37, 2.24]

3 BILEVEL X SMC Show forest plot

7

356

Risk Ratio (M‐H, Random, 95% CI)

1.40 [0.78, 2.49]

4 CPAP X BILEVEL Show forest plot

7

409

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.39, 1.10]

5 BILEVEL X SMC ‐ heterogeneity analysis Show forest plot

6

316

Risk Ratio (M‐H, Random, 95% CI)

1.14 [0.69, 1.88]
Figures and Tables -
Comparison 3. Incidence of acute myocardial infarction (during intervention)
Navigate to table in Review
Comparison 4. Incidence of acute myocardial infarction (after intervention)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

4

154

Risk Ratio (M‐H, Random, 95% CI)

0.70 [0.11, 4.26]

2 CPAP X SMC Show forest plot

2

99

Risk Ratio (M‐H, Random, 95% CI)

1.08 [0.11, 10.23]

3 BILEVEL X SMC Show forest plot

3

65

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.02, 11.54]

4 CPAP X BILEVEL Show forest plot

2

68

Risk Ratio (M‐H, Random, 95% CI)

1.57 [0.57, 4.32]
Figures and Tables -
Comparison 4. Incidence of acute myocardial infarction (after intervention)
Navigate to table in Review
Comparison 5. Intolerance to allocated treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

13

1848

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.29, 0.77]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

12

692

Risk Ratio (M‐H, Random, 95% CI)

0.42 [0.30, 0.58]

3 CPAP X SMC Show forest plot

9

1304

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.36, 0.85]

4 BILEVEL X SMC Show forest plot

7

995

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.24, 1.42]

5 CPAP X BILEVEL Show forest plot

3

894

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.35, 2.53]
Figures and Tables -
Comparison 5. Intolerance to allocated treatment
Navigate to table in Review
Comparison 6. Hospital length of stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

10

542

Mean Difference (IV, Random, 95% CI)

‐0.80 [‐2.10, 0.51]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

9

519

Mean Difference (IV, Random, 95% CI)

‐0.38 [‐1.35, 0.58]

3 CPAP X SMC Show forest plot

5

337

Mean Difference (IV, Random, 95% CI)

‐0.51 [‐1.69, 0.67]

4 BILEVEL X SMC Show forest plot

7

311

Mean Difference (IV, Random, 95% CI)

‐1.38 [‐3.38, 0.62]

5 CPAP X BILEVEL Show forest plot

6

402

Mean Difference (IV, Random, 95% CI)

‐0.46 [‐1.99, 1.07]
Figures and Tables -
Comparison 6. Hospital length of stay
Navigate to table in Review
Comparison 7. ICU length of stay

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

6

222

Mean Difference (IV, Random, 95% CI)

‐0.89 [‐1.33, ‐0.45]

2 CPAP X SMC Show forest plot

3

169

Mean Difference (IV, Random, 95% CI)

‐1.09 [‐1.63, ‐0.56]

3 BILEVEL X SMC Show forest plot

3

53

Std. Mean Difference (IV, Random, 95% CI)

‐0.65 [‐1.37, 0.06]

4 CPAP X BILEVEL Show forest plot

3

159

Mean Difference (IV, Random, 95% CI)

0.31 [‐0.78, 1.40]
Figures and Tables -
Comparison 7. ICU length of stay
Navigate to table in Review
Comparison 8. Breath rate after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

9

438

Mean Difference (IV, Random, 95% CI)

‐2.86 [‐3.85, ‐1.87]

2 CPAP X SMC Show forest plot

7

300

Mean Difference (IV, Random, 95% CI)

‐2.39 [‐3.70, ‐1.07]

3 BILEVEL X SMC Show forest plot

6

254

Mean Difference (IV, Random, 95% CI)

‐3.52 [‐4.80, ‐2.23]

4 CPAP X BILEVEL Show forest plot

5

218

Mean Difference (IV, Random, 95% CI)

0.57 [1.00, 2.13]
Figures and Tables -
Comparison 8. Breath rate after one hour
Navigate to table in Review
Comparison 9. Heart rate after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

9

438

Mean Difference (IV, Random, 95% CI)

‐4.01 [‐8.16, 0.15]

2 NPPV (CPAP and BILEVEL) X SMC ‐ heterogeneity analysis Show forest plot

7

329

Mean Difference (IV, Random, 95% CI)

‐3.79 [‐6.88, ‐0.70]

3 CPAP X SMC Show forest plot

7

300

Mean Difference (IV, Random, 95% CI)

‐4.45 [‐10.81, 1.92]

4 CPAP X SMC ‐ heterogeneity analysis Show forest plot

5

191

Mean Difference (IV, Random, 95% CI)

‐4.10 [‐8.93, 0.72]

5 BILEVEL X SMC Show forest plot

6

254

Mean Difference (IV, Random, 95% CI)

‐4.21 [‐7.77, ‐0.65]

6 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐0.56 [‐5.22, 4.11]
Figures and Tables -
Comparison 9. Heart rate after one hour
Navigate to table in Review
Comparison 10. Sistolic blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

6

182

Mean Difference (IV, Random, 95% CI)

‐1.64 [‐7.83, 4.56]

2 CPAP X SMC Show forest plot

6

211

Mean Difference (IV, Random, 95% CI)

0.12 [‐6.56, 6.81]

3 BILEVEL X SMC Show forest plot

4

87

Mean Difference (IV, Random, 95% CI)

1.93 [‐7.94, 11.80]

4 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐1.17 [‐10.79, 8.44]

5 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot

3

136

Mean Difference (IV, Random, 95% CI)

2.57 [‐4.30, 9.44]
Figures and Tables -
Comparison 10. Sistolic blood pressure after one hour
Navigate to table in Review
Comparison 11. Diastolic blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

5

138

Mean Difference (IV, Random, 95% CI)

‐1.49 [‐6.43, 3.45]

2 CPAP X SMC Show forest plot

5

167

Mean Difference (IV, Random, 95% CI)

‐0.92 [‐9.10, 7.27]

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot

3

107

Mean Difference (IV, Random, 95% CI)

‐7.32 [‐12.79, ‐1.86]

4 BILEVEL X SMC Show forest plot

4

87

Mean Difference (IV, Random, 95% CI)

‐0.96 [‐6.09, 4.16]

5 CPAP X BILEVEL Show forest plot

4

182

Mean Difference (IV, Random, 95% CI)

‐2.60 [‐9.58, 4.37]

6 CPAP X BILEVEL ‐ heterogeneity analysis Show forest plot

2

62

Mean Difference (IV, Random, 95% CI)

‐7.86 [‐13.03, ‐2.70]
Figures and Tables -
Comparison 11. Diastolic blood pressure after one hour
Navigate to table in Review
Comparison 12. Mean blood pressure after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

3

256

Mean Difference (IV, Random, 95% CI)

‐2.41 [‐8.27, 3.45]

2 CPAP X SMC Show forest plot

1

89

Mean Difference (IV, Random, 95% CI)

3.00 [‐5.31, 11.31]

3 BILEVEL X SMC Show forest plot

2

167

Mean Difference (IV, Random, 95% CI)

‐5.42 [‐11.60, 0.76]

4 CPAP X BILEVEL Show forest plot

1

80

Mean Difference (IV, Random, 95% CI)

‐4.40 [‐13.25, 4.45]
Figures and Tables -
Comparison 12. Mean blood pressure after one hour
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Comparison 13. PaO2 (mmHg) after one hour

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

4

140

Mean Difference (IV, Random, 95% CI)

10.04 [1.09, 19.00]

2 CPAP X SMC Show forest plot

5

177

Mean Difference (IV, Random, 95% CI)

‐2.64 [‐25.87, 20.59]

3 CPAP X SMC ‐ heterogeneity analysis Show forest plot

3

117

Mean Difference (IV, Random, 95% CI)

‐22.09 [‐34.35, ‐9.83]

4 BILEVEL X SMC Show forest plot

3

79

Mean Difference (IV, Random, 95% CI)

4.79 [‐11.11, 20.69]

5 CPAP X BILEVEL Show forest plot

3

136

Mean Difference (IV, Random, 95% CI)

‐27.00 [‐44.75, ‐9.25]
Figures and Tables -
Comparison 13. PaO2 (mmHg) after one hour
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Comparison 14. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

15

11329

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.63, 1.16]

1.1 Skin damage

11

594

Risk Ratio (M‐H, Random, 95% CI)

6.62 [1.20, 36.55]

1.2 Pneumonia

3

232

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

1.3 Pulmonary aspiration

5

1255

Risk Ratio (M‐H, Random, 95% CI)

1.58 [0.06, 38.61]

1.4 Gastrointestinal Bleeding

3

192

Risk Ratio (M‐H, Random, 95% CI)

1.37 [0.27, 6.89]

1.5 Gastric distention

8

484

Risk Ratio (M‐H, Random, 95% CI)

13.26 [0.82, 215.12]

1.6 Vomiting

5

1229

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.46, 2.47]

1.7 Asphyxia

2

170

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

1.8 Pneumothorax

6

1474

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.08, 6.89]

1.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.10 Sinusitis

2

219

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

1.11 Disconfort with mask

7

512

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

1.12 Hypotension

1

1030

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.58, 1.16]

1.13 Arrhythmia

1

1027

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.50, 1.38]

1.14 Progressive respiratory distress

2

1122

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.37, 0.89]

1.15 Cardiorespiratory arrest

3

1252

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.29, 1.26]

1.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

1.17 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.18 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.19 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

2 NPPV (CPAP and BILEVEL) X SMC ‐ AFTER 2000 Show forest plot

11

10703

Risk Ratio (M‐H, Random, 95% CI)

0.87 [0.63, 1.19]

2.1 Skin damage

8

492

Risk Ratio (M‐H, Random, 95% CI)

6.62 [1.20, 36.55]

2.2 Pneumonia

2

152

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

2.3 Pulmonary aspiration

2

1095

Risk Ratio (M‐H, Random, 95% CI)

1.58 [0.06, 38.61]

2.4 Gastrointestinal Bleeding

2

170

Risk Ratio (M‐H, Random, 95% CI)

2.32 [0.35, 15.42]

2.5 Gastric distention

4

302

Risk Ratio (M‐H, Random, 95% CI)

13.26 [0.82, 215.12]

2.6 Vomiting

5

1229

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.46, 2.47]

2.7 Asphyxia

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

2.8 Pneumothorax

5

1434

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.08, 6.89]

2.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.10 Sinusitis

2

219

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

2.11 Disconfort with mask

7

512

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

2.12 Hypotension

1

1030

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.58, 1.16]

2.13 Arrhythmia

1

1027

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.50, 1.38]

2.14 Progressive respiratory distress

2

1122

Risk Ratio (M‐H, Random, 95% CI)

0.58 [0.37, 0.89]

2.15 Cardiorespiratory arrest

3

1252

Risk Ratio (M‐H, Random, 95% CI)

0.60 [0.29, 1.26]

2.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

2.17 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.18 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2.19 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

3 CPAP X SMC Show forest plot

10

7133

Risk Ratio (M‐H, Random, 95% CI)

0.63 [0.45, 0.87]

3.1 Skin damage

7

343

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.13, 69.52]

3.2 Pneumonia

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 Pulmonary aspiration

5

908

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.4 Gastrointestinal Bleeding

1

22

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.02, 7.39]

3.5 Gastric distention

7

447

Risk Ratio (M‐H, Random, 95% CI)

11.00 [0.64, 189.65]

3.6 Vomiting

3

785

Risk Ratio (M‐H, Random, 95% CI)

0.93 [0.34, 2.54]

3.7 Asphyxia

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.8 Pneumothorax

5

998

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.9 Conjunctivitis

2

147

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.10 Sinusitis

1

89

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.11 Disconfort with mask

3

265

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

3.12 Hypotension

1

684

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.55, 1.25]

3.13 Arrhythmia

1

682

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.28, 1.09]

3.14 Progressive respiratory distress

2

776

Risk Ratio (M‐H, Random, 95% CI)

0.53 [0.31, 0.92]

3.15 Cardiorespiratory arrest

2

777

Risk Ratio (M‐H, Random, 95% CI)

0.41 [0.18, 0.91]

3.16 Neurological failure (coma)

1

90

Risk Ratio (M‐H, Random, 95% CI)

0.10 [0.01, 0.71]

4 BILEVEL X SMC Show forest plot

8

6823

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.76, 1.46]

4.1 Skin damage

6

296

Risk Ratio (M‐H, Random, 95% CI)

7.16 [1.27, 40.50]

4.2 Nosocomial pneumonia

2

152

Risk Ratio (M‐H, Random, 95% CI)

0.35 [0.05, 2.20]

4.3 Disconfort with mask

5

274

Risk Ratio (M‐H, Random, 95% CI)

5.39 [0.97, 30.09]

4.4 Gastrointestinal bleeding

2

170

Risk Ratio (M‐H, Random, 95% CI)

2.32 [0.35, 15.42]

4.5 Gastric dilatation

2

64

Risk Ratio (M‐H, Random, 95% CI)

15.87 [0.96, 262.30]

4.6 Vomiting

5

848

Risk Ratio (M‐H, Random, 95% CI)

1.21 [0.47, 3.11]

4.7 Claustrophobia

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

4.8 Pneumothorax

2

832

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.11, 9.63]

4.9 Eye irritation

1

40

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4.10 Sinusitis

1

130

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.12, 72.31]

4.11 Cardiac arrest

2

830

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.25, 3.61]

4.12 Stroke

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

4.13 Seizures

1

130

Risk Ratio (M‐H, Random, 95% CI)

0.33 [0.01, 8.03]

4.14 Gastric aspiration

1

704

Risk Ratio (M‐H, Random, 95% CI)

3.09 [0.13, 75.50]

4.15 Hypotension

1

698

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.54, 1.23]

4.16 Arrhythmia

1

695

Risk Ratio (M‐H, Random, 95% CI)

1.10 [0.64, 1.90]

4.17 Progressive respiratory distress

1

700

Risk Ratio (M‐H, Random, 95% CI)

0.61 [0.36, 1.03]

5 CPAP X BILEVEL Show forest plot

5

7593

Risk Ratio (M‐H, Random, 95% CI)

1.18 [0.94, 1.48]

5.1 Skin damage

5

790

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.19, 2.16]

5.2 Pneumothorax

2

715

Risk Ratio (M‐H, Random, 95% CI)

2.89 [0.12, 70.63]

5.3 Pulmonary aspiration

3

796

Risk Ratio (M‐H, Random, 95% CI)

2.88 [0.12, 70.43]

5.4 Gastric distension

3

172

Risk Ratio (M‐H, Random, 95% CI)

1.49 [0.56, 4.00]

5.5 Vomiting

4

857

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.43, 2.19]

5.6 Disconfort with mask

4

735

Risk Ratio (M‐H, Random, 95% CI)

1.03 [0.53, 2.00]

5.7 Increased breathing discomfort

1

576

Risk Ratio (M‐H, Random, 95% CI)

1.42 [0.67, 3.02]

5.8 Hypotension

2

758

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.65, 1.48]

5.9 Arrhythmia

1

677

Risk Ratio (M‐H, Random, 95% CI)

2.00 [1.02, 3.92]

5.10 Progressive respiratory distress

1

679

Risk Ratio (M‐H, Random, 95% CI)

1.19 [0.64, 2.21]

5.11 Cardiorespiratory arrest

1

678

Risk Ratio (M‐H, Random, 95% CI)

1.61 [0.59, 4.38]

5.12 Pharyngeal damage

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.06, 14.69]

5.13 Cough

1

80

Risk Ratio (M‐H, Random, 95% CI)

0.32 [0.01, 7.57]
Figures and Tables -
Comparison 14. Adverse events
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Comparison 15. Hospital or 7‐day mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

21

2263

Risk Ratio (M‐H, Random, 95% CI)

0.72 [0.55, 0.94]
Figures and Tables -
Comparison 15. Hospital or 7‐day mortality
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Comparison 16. Hospital or 30‐day mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

22

2387

Risk Ratio (M‐H, Random, 95% CI)

0.75 [0.60, 0.95]
Figures and Tables -
Comparison 16. Hospital or 30‐day mortality
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Comparison 17. General or 7‐day ETI rate

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 NPPV (CPAP and BILEVEL) X SMC Show forest plot

23

2417

Risk Ratio (M‐H, Random, 95% CI)

0.55 [0.38, 0.78]
Figures and Tables -
Comparison 17. General or 7‐day ETI rate
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