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Ventilación con presión positiva no invasiva como estrategia de desconexión para adultos intubados con insuficiencia respiratoria

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Referencias

References to studies included in this review

Chen 2001 {published data only}

Chen J, Qiu D, Tao D. Time for extubation and sequential noninvasive mechanical ventilation in COPD patients with acute exacerbated respiratory failure who received invasive ventilation. Zhongua Jie He He Hu Xi Za Zhi 2001;24:99‐100. [MEDLINE: 21662201]CENTRAL

Ferrer 2003 {published data only}

Ferrer M, Esquinas A, Arancibia F, Bauer TT, Gonzalez G, Carrillo A, et al. Noninvasive ventilation during persistent weaning failure. American Journal of Respiratory and Critical Care Medicine 2003;168:70‐6. [MEDLINE: 22710254]CENTRAL

Girault 1999 {published data only}

Girault C, Daudenthun I, Chevron V, Tamion F, Leroy J, Bonmarchand G. Noninvasive ventilation as a systematic extubation and weaning technique in acute‐on‐chronic respiratory failure: a prospective, randomized controlled study. American Journal of Respiratory and Critical Care Medicine 1999;160:86‐92. [MEDLINE: 99322255]CENTRAL

Girault 2011 {published and unpublished data}

Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, et al. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure. American Journal of Respiratory and Critical Care Medicine 2011;184:672‐9. [www.clinicaltrials.gov (NCT 00213499)]CENTRAL

Hill 2000 {published data only}

Hill NS, Lin D, Levy M, O'Brien A, Klinger J, Houtchens J, et al. Noninvasive positive pressure ventilation (NPPV) to facilitate extubation after acute respiratory failure: a feasibility study. American Journal of Respiratory and Critical Care Medicine 2000;161:B18. CENTRAL

Nava 1998a {published data only}

Nava S, Ambrosino N, Clini E, Prato M, Orlando G, Vitacca M, et al. Noninvasive mechanical ventilation in the weaning of patients with respiratory failure due to chronic obstructive pulmonary disease: a randomized, controlled trial. Annals of Internal Medicine 1998;128:721‐8. [MEDLINE: 98213266]CENTRAL

Prasad 2009 {published and unpublished data}

Prasad S, Chaudhry D, Khanna R. Role of NIV in weaning from mechanical ventilation in patients of chronic obstructive pulmonary disease—An Indian experience. Indian Journal of Critical Care Medicine 2009;13(4):207‐12. [DOI: 10.4103/0972‐5229.60173]CENTRAL

Rabie 2004 {published data only}

Rabie GM, Mohamed AZ, Mohamed RN. Noninvasive ventilation in the weaning of patients with acute‐on‐chronic respiratory failure due to COPD. Chest2004; Vol. 126(Suppl 4):755. CENTRAL

Rabie Agmy 2012 {published data only}

Rabie Agmy GM, Metwally MM. Noninvasive ventilation in the weaning of patients with acute‐on‐chronic respiratory failure due to COPD. Egyptian Journal of Chest Diseases and Tuberculosis 2012;61(1):84‐91. CENTRAL

Tawfeek 2012 {published data only}

Tawfeek MM, Ali‐Elnabtity AM. Noninvasive proportional assist ventilation may be useful in weaning patients who failed a spontaneous breathing trial. Egyptian Journal of Anaesthesia 2012;28:89‐94. CENTRAL

Trevisan 2008 {published data only}

Trevisan CE, Viera SR, and the Research Group in Mechanical Ventilation Weaning. Noninvasive mechanical ventilation may be useful in treating patients who fail weaning from invasive mechanical ventilation: a randomized clinical trial. Critical Care 2008;12:136. [MEDLINE: 18416851]CENTRAL

Vaschetto 2012 {published data only}

Vaschetto R, Turucz E, Dellapiazza F, Guido S, Colombo D, Cammarota G, et al. Noninvasive ventilation after early extubation in patients recovering from hypoxemic acute respiratory failure: a single‐centre feasibility study. Intensive Care Medicine 2012;38(10):1599‐606. [PUBMED: 22825283 ]CENTRAL

Wang 2004 {published data only}

Wang X, Du X, Zhang W. Observation of the results and discussion on the timing of transition form invasive mechanical ventilation to noninvasive ventilation in COPD patients with concomitant acute respiratory failure. Shandong Medicine 2004;44(7):4‐6. CENTRAL

Wang 2005 {published data only}

Wang C, Zhang Q, Cao Z, Wei L, Cheng Z, Liu S, et al. Collaborating Research Group for Noninvasive Mechanical Ventilation of the Chinese Respiratory Society. Pulmonary infection control window in the treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi‐centre study. Chinese Medical Journal 2005;118(19):1589‐94. CENTRAL

Zheng 2005 {published data only}

Zheng R, Liu L, Yang Y. Prospective randomized controlled clinical study of sequential non‐invasive following invasive mechanical ventilation in patients with acute respiratory failure induced COPD. Chinese Journal of Emergency Medicine 2005;14(1):21‐5. CENTRAL

Zou 2006 {published data only}

Zou S, Zhou R, Chen P, Luo H, Xiang X, Lu Y, Zhu L. Application of sequential noninvasive following invasive mechanical ventilation in COPD patients with severe respiratory failure by investigating the appearance of pulmonary‐infection‐control‐window. Journal of Central Southern University 2006;31(1):120‐5. CENTRAL

References to studies excluded from this review

Celebi 2008 {published data only}

Celebi S, Koner O, Menda F, Omay O, Gunay I, Suzer K, Cakar N. Pulmonary effects of noninvasive ventilation combined with the recruitment maneuver after cardiac surgery. International Anesthesia Research Society 2008;107(2):614‐9. CENTRAL

Du 2009 {published data only}

Du LL, Han H, Zhang XJ, Wei L. Randomized control study of sequential non‐invasive following short‐term invasive ventilation in the treatment of acute respiratory distress syndrome as a result of existing pulmonary disease in elderly patients. Chinese Critical Care Medicine 2009;21(7):394‐6. [PUBMED: 19615128 ]CENTRAL

Duan 2012 {published data only}

Duan J, Guo S, Han X, Tang X, Xu L, Xu X, et al. Dual‐mode weaning strategy for difficult‐weaningtracheotomy patients: a feasibility study. Anesthesia and Analagesia 2012;115(3):597‐604. [PUBMED: 22696608]CENTRAL

Gao Smith 2006 {unpublished data only}

Gao Smith F, Sutton P. Comparison of noninvasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial vs conventional weaning. www.controlled‐trials.com (accessed 28 October 2013). [DOI: 10.1186/ISRCTN32810409; ISRCTN32810409 ]CENTRAL

Ishikawa 1997 {published data only}

Ishikawa S, Ohtaki A, Takahashi T, Koyano T, Hasegawa Y, Ohki S, et al. Noninvasive nasal mask BiPAP management for prolonged respiratory failure following cardiovascular surgery. Journal of Cardiac Surgery 1997;12:176‐9. [MEDLINE: 98057721]CENTRAL

Jiang 1999 {published data only}

Jiang JS, Kao SJ, Wang SN. Effect of early application of biphasic positive airway pressure on the outcome of extubation in ventilator weaning. Respirology 1999;4:161‐5. [MEDLINE: 99311244]CENTRAL

Kilic 2008 {published data only}

Kilic A, Yapici N, Bicer Y, Coruh T, Aykac Z. Early extubation and weaning with bilevel positive airway pressure ventilation after cardiac surgery (weaning with BIPAP ventilation after cardiac surgery). Southern African Journal of Anesthesia and Analgesia 2008;14(5):25‐31. CENTRAL

Kruger 1998 {published data only}

Kruger M, Walther T, Falk V, Rauch T, Schmitt DV, Autschbach R, et al. Prospective randomization of pressure‐controlled (BiPAP) and volume‐controlled (SIMV) ventilation after cardiac surgery. Intensive Care Medicine 1998;24(Suppl):5. CENTRAL

Luo 2001 {published data only}

Luo H, Cheng P, Zhou R. Sequential BiPAP following invasive mechanical ventilation in COPD patients with hypercapneic respiratory failure. Bulletin of Hunan Medical University 2001;26:563‐5. [MEDLINE: 12536544]CENTRAL

Matic 2007 {published data only}

Matic I, Sakic‐Zdravcevic K, Jurjevic M. Comparison of invasive and noninvasive mechanical ventilation for patients with chronic obstructive pulmonary disease: randomized prospective study. Periodicum Biologorum 2007;109(2):137‐45. CENTRAL

Nava 2011 {published data only}

Nava S, Grassi M, Fanfulla F, Domenighetti G, Carlucci A, Perren A, et al. Non‐invasive ventilation in elderly patients with acute hypercapnic respiratory failure: a randomized controlled trial. Age and Ageing 2011;40:444‐50. CENTRAL

Radojevic 1997 {published data only}

Radojevic D, Vuk LJ, Radomir B, Jovic M, Bojic M. PIPAP and PSV in the weaning of cardiosurgical patients from mechanical ventilation. British Journal of Anaesthesia 1997;78(Suppl 1):A161. CENTRAL

Rong 2012 {published data only (unpublished sought but not used)}

Rong F. Application of treating chronic obstructive pulmonary disease patients with respiratory failure with the sequential noninvasive and invasive ventilation. Journal of Bengbu Medical College 2012;37(4):442‐4. CENTRAL

Rosinha 2002 {published data only}

Rosinha SRPOR, Lobo SMA, Sanches HS, Deraldini M, Vidal AMA, Tofoli LT, et al. The use of noninvasive ventilation after weaning of acute respiratory failure prevents reintubation and decreases hospital mortality. American Journal of Respiratory and Critical Care Medicine 2002;165(8):A686. CENTRAL

Vargas 2012 {published data only}

Vargas F, Clavel M, Sanchez P, Garnier S, Boyer A, Bui NH, et al. Sequential and early use of noninvasive ventilation after extubation in patients with chronic respiratory disorders. Americal Journal of Respiratory and Critical Care Medicine 2012;185:A6487. CENTRAL

Venkatram 2010 {published data only}

Venkatram S, Rachmale S, Kanna B, Soni, A. Non‐invasive positive pressure ventilation compared to invasive mechanical ventilation among patients with COPD exacerbations in an inner city MICU‐ Predictors of NPPV use. The Internet Journal of Pulmonary Medicine 2010;12(1). [DOI: 10.5580/284f; ISSN: 1531‐2984]CENTRAL

Wang 2000 {published data only}

Wang C, Shang M, Huang K, et al. Sequential non‐invasive following short‐term invasive mechanical ventilation in COPD induced hypercapneic respiratory failure. Chinese Journal of Tuberculosis and Respiratory Diseases 2000;23(4):212‐6. CENTRAL

Wang 2003 {published data only}

Wang C, Shang M, Huang K, Tong Z, Kong W, Jiang C, et al. Sequential non‐invasive mechanical ventilation following short‐term invasive mechanical ventilation in COPD induced hypercapneic respiratory failure. Chinese Medical Journal 2003;116(1):39‐43. CENTRAL

Yang 2009 {published data only}

Yang SY, Shen JL, Feng EZ. Study on the indication and time of the use of non‐invasive positive pressure ventilation in the patients with acute exacerbation of chronic cor pulmonale combined with type II respiratory failure at high altitude area. Chinese Critical Care Medicine 2009;21(7):440‐1. [ISSN: CN‐00742932]CENTRAL

Zheng 2011 {published data only}

Zheng D, Wang C, Liu R, Gao F, Deng S, Zhou P, et al. The application of improved Glasgow coma scale score of 15 as switching point for invasive‐noninvasive mechanical ventilation in treatment of severe respiratory failure in chronic obstructive pulmonary disease. Chinese Critical Care Medicine 2011;23:224‐7. CENTRAL

Perkins 2013 {unpublished data only}

Protocolized trial of invasive and noninvasive weaning off ventilation: the BREATHE trial. Ongoing study 1 January 2013.

Smith 2013 {unpublished data only}

NEXT: Comparison of noninvasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial versus conventional weaning. Ongoing study 13 March 2006.

Antonelli 1998

Antonelli M, Conti G, Rocco M, Bufi M, DeBlasi RA, Vivino G, Gasparetto A, et al. A comparison of noninvasive positive‐pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. New England Journal of Medicine 1998;339:429‐35. [MEDLINE: 98355343]

Appendini 1994

Appendini L, Patessio A, Zanaboni S, Carone M, Gukov B, Donner CF, et al. Physiological effects of positive end expiratory pressure and mask pressure support during exacerbations of chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine 1994;149:1069‐76. [MEDLINE: 94228042]

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Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, et al. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. American Journal of Respiratory and Critical Care Medicine 1994;150:896‐903. [MEDLINE: 95005672]

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Butler 1999

Butler R, Keenan SP, Inman KJ, Sibbald WJ, Block G. Is there a preferred technique for weaning the difficult‐to‐wean patient? A systematic review of the literature. Critical Care Medicine 1999;27:2331‐6. [MEDLINE: 20043845]

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Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, et al. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. New England Journal of Medicine 1996;335:1864‐9. [MEDLINE: 97096836]

Ely 2001

Ely EW, Meade MO, Haponik EF, Kollef MH, Cook DJ, Guyatt GH, et al. Mechanical ventilator weaning protocols driven by nonphysician health‐care professionals. Evidence‐based clinical practice guidelines. Chest 2001;120 Suppl:454‐63. [MEDLINE: 21607759]

Epstein 1997

Epstein SK, Ciabotaru RL, Wong JB. Effect of failed extubation on the outcome of mechanical ventilation. Chest 1997;112(1):186‐92. [MEDLINE: 9228375]

Esen 1992

Esen F, Denkel T, Telci L, Kesecioglu J, Tutunca AS, Akpir K, et al. Comparison of PSV and IMV during weaning in patients with acute respiratory failure. Advances in Experimental Medicine and Biology 1992;317:371‐6. [MEDLINE: 93167012]

Esteban 1995

Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Vallverdu I, et al. A comparison of four methods of weaning patients from mechanical ventilation. New England Journal of Medicine 1995;332:345‐50. [MEDLINE: 95124404]

Esteban 1997

Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, et al. Extubation outcome after spontaneous breathing trials with T‐tube or pressure support ventilation. American Journal of Respiratory and Critical Care Medicine 1997;156:459‐65. [MEDLINE: 97425174]

Esteban 1999

Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, et al. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. American Journal of Respiratory and Critical Care Medicine 1999;159:512‐8. [MEDLINE: 99126673]

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Goodenberger 1992

Goodenberger DM, Couser JI, May JJ. Successful discontinuation of ventilation via tracheostomy by substitution of nasal positive pressure ventilation. Chest 1992;102:1277‐9. [MEDLINE: 93009934]

Gregoretti 1998

Gregoretti C, Beltrame F, Lucangelo U, Burbi L, Conti G, Turello M, et al. Physiologic evaluation of noninvasive pressure support ventilation in trauma patients with acute respiratory failure. Intensive Care Medicine 1998;24:785‐90. [MEDLINE: 98428888]

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Heyland DK, Cook DJ, Griffith L, Keenan SP, Brun‐Buisson C. The attributable morbidity and mortality of ventilator associated pneumonia in the critically ill patient. The Canadian Critical Care Trials Group. American Journal of Respiratory and Critical Care Medicine 1999;159:1249‐56. [MEDLINE: 99210370]

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Jounieaux 1994

Jounieaux V, Duran A, Levi‐Valensi P. Synchronized intermittent mandatory ventilation with and without pressure support ventilation in weaning patients with COPD from mechanical ventilation. Chest 1994;105:1204‐10. [MEDLINE: 94215367]

Keenan 2003

Keenan SP, Sinuff T, Cook DJ, Hill NS. Which patients with acute exacerbations of COPD benefit from noninvasive positive‐pressure ventilation? A systematic review. Annals of Internal Medicine 2003;138:861‐70. [MEDLINE: 22664221]

Keenan 2004

Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxaemic respiratory failure? A systematic review. Critical Care Medicine 2004;Dec;32(12):2516‐23. [MEDLINE: 15599160]

Keenan 2011

Keenan SP, Sinuff T, Burns KEA, Muscedere J, Kutsogiannis J, Mehta S, et al. as the Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group. Clinical practice guidelines for the use of noninvasive positive‐pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. Canadian Medical Association Journal 2011;183(3):E195‐214. [PUBMED: 21324867]

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Kilger E, Briegel J, Haller M, Frey L, Schelling G, Stoll C, et al. Effects of noninvasive positive pressure ventilatory support in non‐COPD patients with acute respiratory insufficiency after early extubation. Intensive Care Medicine 1999;25:1374‐80. [MEDLINE: 20126681]

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MacIntyre NR, Cook DJ, Ely EW, Epstein SK, Fink JB, Heffner JE, et al. Evidence‐based guidelines for weaning and discontinuing ventilatory support. A collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. Chest 2001;6 Suppl:375‐95. [MEDLINE: 21607753]

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References to other published versions of this review

Burns 2003

Burns KEA, Adhikari NKJ, Meade MO. Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure. Cochrane Database of Systematic Reviews 2003, Issue 4. [DOI: 10.1002/14651858.CD004127]

Burns 2009

Burns KEA, Adhikari NKJ, Keenan SP, Meade MO. Use of non‐invasive ventilation to wean critically ill adults off invasive ventilation: meta‐analysis and systematic review. BMJ 2009;338:b1574. [DOI: 10.1136/bmj.b1574.; MEDLINE: 19560803]

Burns 2010

Burns KEA, Adhikari NKJ, Keenan SP, Meade MO. Noninvasive positive pressure ventilation as a weaning strategy for intubated adults with respiratory failure. Cochrane Database of Systematic Reviews 2010, Issue 8. [DOI: 10.1002/14651858.CD004127.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Chen 2001

Methods

Pseudo‐randomized
(n = 24)

Participants

Participants were admitted with an acute exacerbation of COPD. Participants were invasively ventilated through a nasotracheal tube for 48 to 60 hours
Inclusion criteria:
pH less than 7.35
PaO2 less than 45 mm Hg and RR greater than 30 breaths/min

Interventions

Participants were randomly assigned by alternating day of the month to receive noninvasive ventilation in PS mode or continued weaning with invasive PS. PS and PEEP were gradually decreased to facilitate liberation from mechanical support. Ventilation was discontinued after a three‐hour SBT was completed and discontinuation criteria were met

Outcomes

1. Mortality
2. VAP
3. Duration of MV related to weaning
4. Hospital LOS

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Participants randomly assigned to group A or B on the basis of order of hospital admission

Allocation concealment (selection bias)

High risk

Used order of hospital admission

Incomplete outcome data (attrition bias)
All outcomes

Low risk

None missing

Selective reporting (reporting bias)

Unclear risk

Primary and secondary outcomes not specified. Clinically important outcomes reported

Ferrer 2003

Methods

RCT
(n = 43)

Two centres

Computer‐generated list held by investigator not involved in participant care

Participants

Participants with ARF and persistent weaning failure requiring MV for at least 72 hours and failing a two‐hour T‐piece trial on three consecutive days. Participants were identified by daily screening prerandomization

Interventions

Participants were randomly assigned to bilevel positive airway pressure in ST mode or invasive weaning with AC or PS. Daily T‐piece trials were conducted until extubation in the IPPV group. Periods of SB of increasing duration were used to wean NPPV. IPPV was discontinued after successful completion of a two‐hour SBT

Outcomes

1. ICU mortality
2. 90‐day mortality
3. VAP
4. Duration of MV related to weaning
5. Duration of ETMV
6. Total duration of MV
7. ICU LOS
8. Tracheostomy
9. Reintubation
10. Adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Participants randomly assigned with the use of a computer‐generated table for each centre

Allocation concealment (selection bias)

Low risk

Computer‐generated table held by an investigator not involved in the study

Incomplete outcome data (attrition bias)
All outcomes

Low risk

None missing

Selective reporting (reporting bias)

High risk

Proportions of weaning successes and failures not reported in publication of full trial. This outcome was previously reported in a smaller number of participants in an earlier abstract publication (2000). Study authors did not continue to collect data on this outcome

Girault 1999

Methods

RCT
(n = 33)

Opaque envelopes

Participants

Participants with acute‐on‐chronic respiratory failure (COPD, restrictive, mixed) failing a two‐hour T‐piece trial after invasive mechanical ventilation for at least 48 hours. Participants were identified through daily screening

Interventions

Participants were randomly assigned to receive invasive pressure support or NPPV delivered in flow or pressure mode. NPPV was delivered intermittently following extubation, separated by periods of SB of increasing duration. Invasive PS was titrated by 3 to 5 cm H2O according to tolerance. Discontinuation of support followed successful completion of two periods of observation during SB (NPPV) or during PS weaning with optional SBTs (IPPV). Extubation was performed when PS was less than 8 cm H2O in the IPPV group

Outcomes

1. 90‐day mortality
2. Hospital mortality
3. Successful weaning
4. VAP
5. Duration of MV related to weaning
6. Duration of ETMV
7. Mean daily period of support
8. ICU LOS
9. Hospital LOS
10. Adverse events
11. Reintubation
12. Tracheostomy

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not specified. Randomization and introduction of the weaning procedure IPSV or NPPV were done during the 24 hours after the two‐hour SBT

Allocation concealment (selection bias)

Unclear risk

Opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes

Low risk

None missing

Selective reporting (reporting bias)

Low risk

Protocol not available. Published manuscript reports on prespecified outcomes

Girault 2011

Methods

RCT

(n = 208) three arms, of which two arms (n = 138) were included in the pooled results

13 ICUs/centres

Computer‐generated randomization table using variable blocks of four

Sealed, opaque envelopes

Participants

Participants with chronic hypercapneic respiratory failure based on history, chest radiograph, arterial blood gases in steady state and/or bicarbonate level and pulmonary function tests (if available) who were intubated for at least 48 hours, regardless of cause of the disorder. Participants were clinically stable for at least 24 hours and underwent an SBT after meeting weaning criteria as determined by a daily screening evaluation. Participants who failed an SBT were assigned to one of the three treatment groups. Two groups (invasive weaning and NPPV weaning) were included in the pooled analysis

Interventions

Participants were randomly assigned to conventional invasive weaning (n = 69), oxygen‐therapy (n = 70) or noninvasive ventilation (n = 69). Conventional invasive weaning was performed using one or more daily SBTs with the use of a T‐piece or PSV (with or without PEEP) in 20% of participants. In the oxygen‐therapy and NPPV groups, respectively, SBTs were followed by a re‐ventilation period of at least 30 minutes duration and extubation (same day as randomization) or standard oxygen therapy to maintain SaO2> 90% or immediate NPPV with a face mask. NPPV was performed for > six hours and was administered continuously initially and intermittently subsequently with spontaneous breathing periods using supplemental oxygen

Outcomes

1. Mortality (before eighth day after randomization)

2. Mortality (before 29th day after randomization)

3. ICU mortality (before 29th day after randomization)

4. Hospital mortality (before 29th day after randomization)

5. Total duration of ventilation

6. Duraion of ventilation related to weaning

7. Ventilator‐free days

8. Complications (auto extubation, postextubation stridor, tube obstruction, respiratory encephalopathy, bronchial hypersecretion, nosocomial pneumonia, sinusitis, atelectasis, cardiac arrhythmia, haemodynamic collapse, ACPE, paralytic ileus, gastric distension, mask intolerance)

9. Respiratory support at discharge

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated randomization table using variable blocks of four

Allocation concealment (selection bias)

Low risk

Sealed, opaque envelopes according to centre stratification

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All specific outcomes reported

Hill 2000

Methods

RCT
(n = 21)

(abstract)

Sealed, opaque envelopes

Participants

Participants with acute respiratory failure admitted to a medical intensive care unit and failing a 30‐minute T‐piece trial were eligible. Participants were identified through daily screening

Interventions

Participants were randomly assigned to receive VPAP using PS, delivered in ST mode, or invasive PS. In both arms, mechanical support was titrated to RR and tidal volume. Whereas two‐hour T‐piece trials were permitted to discontinue IPPV support in the IPPV group, NPPV was discontinued by gradually increasing periods between NPPV trials until participants were able to breathe spontaneously between NPPV sessions for two hours without increasing RR or dyspnoea

Outcomes

1. Mortality
2. Successful weaning
3. Duration of ETMV
4. Reintubation

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Clarified to be randomized. Uncertain sequence generation

Allocation concealment (selection bias)

Low risk

Sealed, opaque envelopes (unclear whether sequentially numbered)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

None missing

Selective reporting (reporting bias)

Low risk

Abstract publication only. Published abstract reports the duration of invasive ventilation

Nava 1998a

Methods

RCT
(n = 50)

Three centres
Opaque, sealed envelopes

Participants

Participants admitted with an acute exacerbation of COPD requiring intubation and MV for at least 36 to 48 hours. Relapse was defined as pH less than 7.33, PaO2 less than 45 mm Hg, severe dyspnoea in the absence of pneumonia or one of 11 nonoperative diagnoses. Participants who met permissive criteria and failed a one‐hour T‐piece trial were eligible for inclusion

Interventions

Participants were intubated, sedated and paralysed for the first six to eight hours. Those failing a one‐hour T‐piece trial were randomly assigned to weaning with NPPV or IPPV. NPPV was delivered continuously with at least two periods of SB per day of increasing duration. PS was decreased by 2 to 4 cm H2O per day in the NPPV group. In the IPPV group, PS was titrated to an RR of less than 25 breaths/min, and twice‐daily SBTs were permitted. Discontinuation occurred after successful completion of a three‐hour period of SB (NPPV) or SBT (IPPV) and when discontinuation criteria were met

Outcomes

1. 60‐day mortality

2. VAP

3. Successful weaning at 60 days

4. Total duration of MV

5. ICU LOS

6. Adverse events

7. Tracheostomy

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Participants "were randomly assigned"

Allocation concealment (selection bias)

Low risk

Using sealed, opaque, numbered envelopes

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

Authors report on important outcomes, including weaning outcomes (success or failure), mortality, VAP, total duration of ventilation and ICU length of stay

Prasad 2009

Methods

Participants

Interventions

Participants were initially ventilated in AC mode and were treated with muscle relaxants and sedation to achieve standard ventilator settings. After at least 24 hours of MV and meeting permissive criteria, a T‐piece trial was conducted. Participants failing the T‐piece trial were randomly assigned to NPPV or IPPV weaning

NPPV and IPPV were initiated in pressure mode (with a full face mask) and with the use of invasive PS, respectively. NPPV was applied continuously (except for meals, expectoration). IPAP and EPAP levels were adjusted to achieve satisfactory blood gases and RR less than 25 breaths/min. Thereafter, noninvasive or invasive PS was decreased by 2 cm H2O every four hours, titrated to good tolerance (monitoring for changes in saturations and RRs). Both noninvasive and invasive PS (above PEEP) were titrated to participant tolerance, blood gases and RR. Once NPPV was decreased to IPAP and EPAP of 8 and 4 cm H2O, respectively, and invasive PS and PEEP were titrated to 10 and 5 cm H2O, respectively, with pH greater than or equal to 7.35, SaO2 greater than or equal to 90%, RR < 30 breaths/min and FiO2 less than or equal to 40%, participants were allowed to breathe spontaneously on a Venturi mask or were extubated to a Venturi mask

Outcomes

1. 30‐day mortality
2. ICU mortality
3. Duration of MV related to weaning
4. ICU LOS
5. VAP
6. Duration of ETMV
7. Deaths due to VAP
8. Adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Reported using a Kendall and Babington table

Allocation concealment (selection bias)

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All specified outcomes reported

Rabie 2004

Methods

RCT
(n = 37)

One centre
(abstract)

Allocation concealment not described

Participants

Intubated participants with an acute‐on‐chronic exacerbation of COPD, who failed a two‐hour SBT despite meeting simple weaning criteria

Interventions

After intubation, participants were ventilated in controlled mode, received sedation and paralysis for the first six to eight hours and were treated with PS for an additional 60 hours. A T‐piece trial was carried out once participants achieved a satisfactory neurological status and normal temperature and were haemodynamically stable. Participants failing the T‐piece trial were randomly assigned to NPPV (initiated by face mask or nasal mask using BiPAP in PAV/T mode) or continued invasive PS. IPPV was titrated by 2 to 4 cm H2O per day. NPPV was delivered until well tolerated (20 to 22 hours per day), spaced by periods of spontaneous inhalation of oxygen only during meals and for expectoration. The level of PS was decreased by 2 to 4 cm H2O per day in participants with good tolerance. At least two trials of spontaneous breathing of gradually increasing duration were attempted each day. Criteria for weaning from invasive PS or NPPV were SaO2 of 90% or greater with an FiO2 of 40% or less, pH of 7.35 or more, RR less than 35 breaths/min, haemodynamic stability, absence of severe dyspnoea and depressed neurological status. The absence of any of these criteria was considered failure to wean. Participants were screened daily for weaning criteria

Outcomes

1. Weaning failure
2. Weaning duration
3. ICU LOS
4. Hospital LOS
5. Reintubation

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Treatment assignment "was randomized". Author confirms that he used a central computer and that group allocation was communicated by a computer

Allocation concealment (selection bias)

Low risk

The author reported that investigators did not know in advance to which arm the participant would be allocated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Personal communication: "Follow‐up was complete"

Selective reporting (reporting bias)

Low risk

The authors reported clinically important outcomes. Note is made that they did not report the duration of ventilation related to weaning, although this was not a prespecified outcome in this study

Rabie Agmy 2012

Methods

RCT
(n = 264)

(abstract)

Allocation concealment not described

Participants

Intubated participants with acute‐on‐chronic respiratory failure due to COPD who failed a two‐hour SBT, although they met simple criteria for weaning

Interventions

Conventional invasive PSV (n = 130) was compared with NPPV immediately followed by extubation (n = 134)

Outcomes

1. Gas exchange

2. Duration of ETMV

3. Weaning failure

4. Nosocomial pneumonia

5. ICU LOS

6. Hospital LOS

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomization sequence was determined using a central computer, and group allocation was communicated by the computer

Allocation concealment (selection bias)

Low risk

The author reported that investigators did not know in advance to which arm the participant would be allocated

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All randomly assigned participants appear to be accounted for in the analysis

Selective reporting (reporting bias)

Low risk

The authors reported on gas exchange, duration of ETMV, weaning failure rates, nosocomial pneumonia rates and ICU and hospital LOS in their full publication

Tawfeek 2012

Methods

RCT

(n = 42)

One centre

Opaque, sealed, numbered envelopes

Participants

Participants invasively ventilated for longer than 48 hours who failed a two‐hour SBT, despite meeting simple weaning criteria

Interventions

Participants who failed an SBT were randomly allocated to SIMV or noninvasive PAV ventilation

In the control SIMV group, ventilatory parameters were adjusted until previous PaCO2 and pH values were reached within the first 60 minutes, and the respiratory rate was < 30 breaths/min. In the PAV group, flow and volume assist PAV were adjusted separately

Outcomes

1. Gas exchange

2. Duration of ventilatory support

3. Survival at 30 days

4. Complications: septic shock, pneumothorax and VAP

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not specified

Allocation concealment (selection bias)

Low risk

Random assignment was performed using opaque, sealed and numbered envelopes

Incomplete outcome data (attrition bias)
All outcomes

Low risk

The authors randomly assigned 42 participants (21 per group), and the denominators for reported outcomes reflect 21 participants per group

Selective reporting (reporting bias)

Low risk

All specified outcomes were reported

Trevisan 2008

Methods

RCT

(n = 65)

One centre

Sealed envelopes

Participants

Participants receiving mechanical ventilation for longer than 48 hours who failed a 30‐minute spontaneous breathing trial. Participants considered apt to undergo the weaning procedure were submitted to an SBT. Participants had already been randomly assigned to one of the ventilator modes (NPPV or IPPV) that would be used in the event that they failed an SBT

Interventions

After failing a T‐piece trial, participants were randomly divided into two groups: Participants were extubated and placed on NPPV or were returned to invasive mechanical ventilation. For participants randomly assigned to NPPV, IPAP was delivered according to participant tolerance (varied from 10 to 30 cm H2O), and EPAP was set to maintain gas exchange and FiO2 was set to maintain SpO2 greater than 90%. A face mask was used. Weaning from NPPV was performed on a daily basis by gradually reducing pressure levels until adequate VT and minute ventilation levels could be reached and proper alveolar ventilator established. In the IPPV group, a daily SBT was conducted to evaluate the possibility of extubation

Outcomes

1. ICU length of stay

2. Hospital length of stay

3. Total length of stay in hospital

4. ICU mortality

5. Hospital mortality

6. Duration of ventilation after randomization

7. Total duration of mechanical ventilation

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

The authors describe the trial as an "experimental randomized clinical trial" and state that a "randomized clinical trial was conducted" but do not provide details regarding sequence generation

Allocation concealment (selection bias)

Unclear risk

Sealed envelopes

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

Study protocol is not available. The published manuscript includes prespecified outcomes

Vaschetto 2012

Methods

RCT

(n = 20)

Sealed opaque, sequentially numbered envelopes

Participants

Included participants were mechanically ventilated for longer than 48 hours, had a PaO2/FiO2 ratio between 200 and 300 with FiO2< 0.60 in PS mode and total applied pressure (PEEP + inspired pressure) < 25 cm H2O, PaCO2< 50, pH > 7.35, RR < 30 breaths/min, core temperature < 38.5ºC, cough on suctioning, need for tracheobronchial suctioning < two per hour and GCS = 11

Interventions

Participants with hypoxaemic ARF were randomly assigned to early extubation followed by NPPV via helmet (helmet group) or conventional weaning through endotracheal tube (tube group)

Outcomes

1. Days of mechanical ventilation and adherence to study protocol (primary outcomes)

2. Weaning failure

2. Hospital mortality

4. ICU mortality

5. Tracheotomy

6. Continuous sedation

7. Weaning time

8. Septic complications

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Authors used a table of random numbers, held by investigator not involved in study enrolment

Allocation concealment (selection bias)

Low risk

Participants were randomly assigned with the use of sealed, sequentially numbered, opaque envelopes

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

All specified outcomes reported

Wang 2004

Methods

RCT

(n = 28)

One respiratory intensive care unit

Allocation concealment not described

Participants

28 invasively ventilated participants with COPD and bronchopulmonary infection. Participants were placed on volume‐controlled AC after intubation and then were switched to SIMV + PS + PEEP. When their infection had been brought under control (decreased sputum, sputum less tenacious and purulent, body temperature less than 37.5°C, WBC less than 10 × 109/L, chest x‐ray improved but not resolved), participants were treated differently

Interventions

Participants in the IPPV group were ventilated until blood gases approached normal values and they had fulfilled the weaning criteria (spontaneous breathing for longer than three hours, FiO2 less than or equal to 40%, SpO2 greater than or equal to 90%, pH greater than or equal to 7.35 and RR less than or equal to 35 breaths/min, with stable haemodynamics and clear consciousness), at which time they were extubated. Participants in the NPPV group were extubated and were switched to mask NPPV with PS + PEEP. In both groups, investigators closely monitored the time infection was brought under control, blood gases and mechanical ventilation parameters

Outcomes

1. Time to control of lung infection

2. Length of ICU stay

3. Duration of mechanical ventilation

4. Mortality

5. VAP

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Reported in the abstract that participants were "randomly assigned" and that "28 patients were randomized equally in 2 groups". No mention is made of sequence generation

Allocation concealment (selection bias)

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Low risk

The authors reported clinically important outcomes in the context of wanting to explore the effects of and optimal timing for noninvasive weaning

Wang 2005

Methods

RCT

(n = 90)

11 teaching hospitals RICUs, MICUs

Allocation concealment not described

Participants

Intubated COPD participants, 85 years of age or younger, with severe hypercapneic respiratory failure due to bronchial pulmonary infection, who were capable of self care in the past year

Interventions

Participants were ventilated with AC (4 to 12 hours) and subsequently with SIMV/PS. Ventiltor rate was gradually decreased to 10 to 12 breaths/min with 10 to 12 cm H2O PS. When the PIC window appeared, participants were randomly assigned to NPPV (BiPAP) or IPPV (continued SIMV/PS). Nonivasive PS (with PEEP of 4 to 6 cm H2O) was adjusted to RR < 28 breaths/min, PaO2 65 to 90 mm Hg and PaCO2 between 45 and 60 mm Hg or at level before extubation. NPPV was considered weaned when PS was decreased until the difference between IPAP and EPAP was less than or equal to 5 cm H2O and the participant was stable. In the IPPV group, participants were weaned using SIMV + PS. Participants were weaned when the SIMV rate had been decreased to 5 breaths/min, the level of PS was 5 to 7 cm H2O and the participant had remained stable for four hours

Outcomes

1. Hospital mortality
2. Total duration of MV
3. ICU LOS
4. Hospital LOS
5. VAP
6. Duration of ETMV
7. Reintubation
8. Costs

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"A prospective randomized controlled trial was conducted in 11 teaching hospitals." Sequence generation not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data apparent

Selective reporting (reporting bias)

Low risk

The authors wanted to examine the feasibility and efficacy of early extubation with sequential NPPV and reported clinically important outcomes

Zheng 2005

Methods

RCT
(n = 33)

Allocation concealment not described

Participants

Intubated participants with COPD with severe respiratory failure due to pulmonary infection, who were capable of self care in the past year

Interventions

Once pulmonary infection had been significantly controlled (PIC window appeared), participants were randomly assigned to NPPV versus invasive PS.
NPPV was administered in BiPAP mode with a face mask. The criteria for the PIC window were (1) chest x‐ray showed improvement in infectious infiltrates, (2) WBC count was less than 10 × 109/L, (3) sputum was decreased and was less purulent or white, with sputum tenacity decreased (lower than grade II). In the IPPV group, participants were weaned with PS. Inspiratory pressure was decreased gradually to less than or equal to 8 cm H2O to keep RR less than 28 breaths/min, VT approximately 8 mL/kg, SpO2 greater than 90% and PaCO2 between 45 and 60 mm Hg or at baseline levels. If participants were stable for four hours with a spontaneous cough, they were extubated. In the NPPV group, participants were ventilated with a nasal or oral mask using BiPAP. Inspiratory pressure and FiO2 were adjusted to keep RR lower than 28 breaths /min, VT approximately 8 mL/kg, SpO2 greater than 90% and PaCO2 between 45 and 60 mm Hg or at pre‐extubation levels. All participants received 4 to 6 cm H2O PEEP to reduce the work of breathing from intrinsic PEEP. The duration of NPPV was longer than two hours initially, and investigators gradually decreased the duration of NPPV and inspiratory pressure daily until NPPV was required for less than two hours per day and inspiratory pressure was less than 10 cm H2O

Outcomes

1. Hospital mortality
2. Total duration of MV
3. ICU LOS
4. Hospital LOS
5. VAP
6. Time to PIC window
7. Duration of ETMV

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Prospective, randomized, controlled clinical study. No mention of sequence generation

Allocation concealment (selection bias)

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No denominators reported in binary outcomes

Selective reporting (reporting bias)

Low risk

Clinically important outcomes reported

Zou 2006

Methods

RCT
(n = 76)

RICU (one hospital)

Allocation concealment not described

Participants

COPD participants (nasotracheally intubated) with respiratory failure due to pulmonary infection

Interventions

All participants were initially treated with AC + SIMV + PS with 3 to 5 cm H2O PEEP. After the PIC window (1) full consciousness, effective expectoration, stable haemodynamics, (2) more noticeable absorption of patchy infectious infiltrates compared to before, with no merging shadows and (3) two or more of the following: (a) temperature lower than 38.0°C, (b) peripheral WBC lower than 10.0 × 109/L or percent neutrophils lower than 78.0% and (c) noticeable decrease in the amount of phlegm, the colour of which had turned white or had become lighter and thickness decreased to below grade II) had been reached, participants were randomly assigned to NPPV or IPPV

Whereas NPPV was applied with a face or nasal mask in pressure (ST mode), SIMV with PS was used in the IPPV group. IPAP and EPAP were titrated to respiratory condition, arterial gases, RR < 25 to 28 breaths/min, SpO2 > 90 and PaCO2 between 45 and 60 or at baseline. All participants were kept on noninvasive mechanical ventilation for longer than two hours during the initial application. Noninvasive time was gradually decreased and IPAP was gradually decreased until NPPV was stopped when BiPAP time was less than two hours each day and IPAP level was less than 10 cm H2O. Invasive PS was gradually reduced to less than or equal to 10 cm H2O with FiO2 less than or equal to 50% titrated to the same parameters and to a tidal volume of 8 mL/kg. IPPV was stopped when conditions were stable for longer than four hours and participants were able to swallow and expectorate spontaneously

Outcomes

1. Inpatient mortality
2. Overall MV time
3. ICU LOS
4. Hospital LOS
5. VAP
6. Duration of ETMV
7. Reintubation

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Digital table

Allocation concealment (selection bias)

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No denominators reported in binary outcomes

Selective reporting (reporting bias)

Low risk

Clinically important outcomes reported

RCT: randomized controlled trial; COPD: chronic obstructive pulmonary disease; b/min: breaths per minute; PaO2: arterial partial pressure of oxygen; PaCO2: arterial partial pressure of carbon dioxide; RR: respiratory rate; ARF: acute respiratory failure; MV: mechanical ventilation; AC: assist control; PS: pressure support; PAV: proportional assist ventilation; SIMV: synchronized intermittent mandatory ventilation; PEEP: positive end‐expiratory pressure; NPPV: noninvasive positive‐pressure ventilation; IPPV: invasive positive‐pressure ventilation; IPAP: inspiratory positive airway pressure; EPAP: expiratory positive airway pressure; VPAP: ventilator (delivered) positive airway pressure; SB: spontaneous breathing; SBT: spontaneous breathing trial; ST: spontaneous timed; T: timed mode; LOS: length of stay; VAP: ventilator‐associated pneumonia; ETMV: endotracheal mechanical ventilation; ICU: intensive care unit; PIC: pulmonary infection control window; RICU: respiratory intensive care unit; MICU: medical intensive care unit; PaO2: arterial partial pressure of oxygen; PaCO2: arterial partial pressure of carbon dioxide; SpO2: pulse oximetry oxygen saturation; FiO2: fractional concentration of inspired oxygen.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Celebi 2008

This study randomly assigned postoperatively 100 participants who had undergone coronary artery bypass surgery to the following four groups: (1) recruitment maneuver (RM) with sustained inflation (n = 25), (2) RM combined with NPPV applied for 30‐minute periods every six hours on the first postoperative day after tracheal extubation (n = 25), (3) NPPV after tracheal extubation (n = 25) and (4) a control group that received neither RM or NPPV (n = 25). The authors reported outcomes that included pulmonary function tests, oxygenation index and atelectasis on chest radiograph. This study was excluded because all participants were extubated within six hours of intervention, and because it did not report clinically important outcomes

Du 2009

This trial of 32 elderly participants with ARDS randomly assigned participants to oronasal CPAP or SIMV + PS when the "ARDS control window" appeared. We excluded this trial because it compared extubation versus CPAP with no inspiratory assist. We did not consider CPAP to be a weaning modality

Duan 2012

This randomized trial compared noninvasive weaning (using a face mask) versus continued invasive weaning in 32 exclusively tracheostomized participants. We excluded this trial because (1) tracheostomy was an outcome of our review, (2) this study included a high proportion of participants undergoing prolonged mechanical ventilation and (3) interventions were applied in a different manner in the setting of a tracheostomy. For example, participants randomly assigned to noninvasive weaning could have met criteria to return to invasive ventilation per tracheostomy and subsequently could have been returned to noninvasive ventilation. Similarly, participants randomly assigned to invasive weaning could have undergone a series of SBTs before extubation

Gao Smith 2006

This trial randomly assigned participants who failed a spontaneous breathing trial to standard treatment (placed back on supported breaths) and compared these participants with those who were extubated and placed on noninvasive ventilation. NPPV was initially set at the same support settings as the ventilator and was reduced accordingly by nursing staff. Conventionally ventilated participants underwent daily spontaneous breathing trials. The trial was aborted after approximately eight participants had been enrolled

Ishikawa 1997

This nonrandomized study assessed the role of BIPAP in the management of respiratory failure after cardiovascular surgery. Twenty participants who required respiratory support for longer than 72 hours were studied. BiPAP (n = 8) was compared with unassisted oxygen treatment (n = 12) in the control group. Outcomes reported included respiratory index, alveolar arterial oxygen difference and shunt fraction. This study was excluded as it was not an RCT. In addition, NPPV was not used to facilitate weaning, and physiological end points alone were reported

Jiang 1999

This RCT evaluated the effects of early application of NPPV on extubation outcome in 93 participants after elective (n = 56) or unplanned (n = 37) extubation. After extubation, participants were randomly assigned to receive NPPV or oxygen therapy. This study did not assess the role of NPPV as a weaning modality

Kilic 2008

In this study, 60 participants, after cardiac surgery, were randomly assigned to PS‐CPAP or bilevel positive airway pressure, both administered invasively, with bilevel positive airway pressure continued after extubation. Outcomes included blood gases and haemodynamics on arrival to the ICU and one, two, four, six, eight and 12 hours later. This study was excluded, as both treatment groups were predominantly weaned invasively, participants were ventilated for less than 24 hours and the outcomes reported were physiological

Kruger 1998

This RCT evaluated 572 participants who underwent median sternotomy and hypothermic cardiac arrest for cardiopulmonary bypass. Participants were randomly assigned to receive BiPAP (n = 280) or SIMV with PS (n = 292). Outcomes reported included duration of intubation (reported in hours), proportion of participants extubated within six hours, requirement for postoperative analgesia and reintubation rate. This study did not assess the role of NPPV as a weaning strategy in postoperative participants with respiratory failure

Luo 2001

This RCT evaluated 32 participants with COPD requiring intubation for hypercapneic respiratory failure. Participants were randomly assigned to receive BiPAP (n = 19) or conventional therapy (n = 13). Reported outcomes included gas exchange at 45 minutes and 12 hours after extubation and rates of reintubation. This study assessed the role of NPPV not as a weaning strategy, but rather as an aid in transitioning participants to spontaneous breathing. Moreover, in this study, the comparator group was not mechanically ventilated

Matic 2007

This RCT compared NPPV and IPPV as early treatment strategies in COPD participants requiring more than 24 hours of MV. The goals of the study were to compare (1) the influence of physiological parameters on the choice of mechanical ventilation strategy in the treatment of COPD and (2) outcomes using the alternative mechanical ventilation strategies. This study evaluated NPPV and IPPV as initial approaches to mechanical ventilation.

Nava 2011

In this RCT, 82 participants were randomly assigned to receive NPPV plus standard medical therapy or standard medical therapy (SMT). Outcomes included rate of meeting endotracheal intubation (ETI) criteria, mortality rate, respiratory rate, dyspnoea score and arterial blood gases. This study evaluated the role of NPPV in reducing the rate of ETI criteria, not as a weaning strategy

Radojevic 1997

In this prospective, randomized study, participants received BIPAP or PS in the early postoperative period after undergoing aortocoronary bypass surgery (seven hours plus or minus one hour). Criteria for eligibility included an awake participant with neuromuscular activity. The population studied represents a cohort of participants in the post–acute care setting that did not require formal weaning

Rong 2012

Participants were not consistently randomly assigned

Rosinha 2002

This prospective RCT allocated participants requiring MV for longer than 72 hours to receive NPPV or supplemental oxygen, by mask, after achieving criteria for extubation. Proportion of successful extubations, length of ICU stay and hospital mortality were reported. This study did not assess the role of NPPV as a weaning strategy, as the comparative group received unassisted oxygen alone

Vargas 2012

This multicentre trial, involving 144 participants, randomly assigned participants to receive NPPV for 48 hours after planned extubation or conventional oxygen treatment. This trial did not assess the role of NPPV in weaning participants from mechanical ventilation, and the comparator group received supplemental oxygen alone

Venkatram 2010

This study was a retrospective study that compared participants managed with NPPV (n = 110) and those managed through invasive mechanical ventilation (n = 156). Duration of ventilatory support, hospital and ICU mortality and NPPV failure rate were reported. The study was not randomized

Wang 2000

This study compared early extubation and sequential NPPV application versus continued invasive ventilation in 11 participants with exacerbations of COPD due to pulmonary infection. The intervention group was compared with a cohort of 11 participants who continuously received invasive MV after control of pulmonary infection had been achieved. This was not an RCT

Wang 2003

This study represents a duplicate publication of Wang 2000

Yang 2009

This study compared standard treatment versus standard treatment with NPPV and did not include invasively ventilated participants

Zheng 2011

This study was a prospective cohort study that included 20 invasively ventilated COPD participants with respiratory failure. Reported outcomes included ventilation and oxygenation index, duration of ETMV, total duration of mechanical ventilation, hospital LOS and rates of reintubation and VAP. This study was excluded, as it was not randomized

BiPAP: bilevel positive airway pressure; RCT: randomized controlled trial; NPPV: noninvasive positive‐pressure ventilation; SIMV: synchronized intermittent mandatory ventilation; PS: pressure support; ARF: acute respiratory failure; ICU: intensive care unit; COPD: chronic obstructive pulmonary disease; MV: mechanical ventilation.

Characteristics of ongoing studies [ordered by study ID]

Perkins 2013

Trial name or title

Protocolized trial of invasive and noninvasive weaning off ventilation: the BREATHE trial

Methods

RCT

(n = 920)

http://www.warwick.ac.uk/breathe

Allocation concealment not described

Participants

Participants with respiratory failure who received invasive ventilation for longer than 48 hours (from the time of intubation) and who failed a spontaneous breathing test (SBT)

Inclusion criteria:

1. Male and female participants, age > 16 years

2. Participants with respiratory failure who had received invasive ventilation for longer than 48 hours (from intubation)

3. Failure of an SBT

4. Provision of written informed consent

Exclusion criteria:

1. Presence of a tracheostomy

2. Profound neurological deficits

3. Any absolute contraindication to NIV

4. Home ventilation before ICU admission

5. Decision not to reintubate or withdrawal of care

6. Further surgery/procedure requiring sedation planned in the next 48 hours

7. Previous participation in the trial

Interventions

Invasive versus noninvasive weaning

Protocolized invasive weaning arm: The participant will be restarted on PS ventilation at the previous settings. The level of PS will be titrated to achieve comfort and RR < 30 breaths/min. Causes for distress/fatigue/weaning failure will be sought and corrective treatments initiated as appropriate. The participant will be reassessed every two hours. If no signs of distress are noted, the level of PS will be reduced by 2 cm H2O. If at any stage the participant develops distress/fatigue, the PS will be increased by 2 cm H2O. FiO2 will be titrated to maintain SaO2 > 90%. A further SBT will take place each morning. This cycle will continue until the participant has been extubated (passing an SBT or tolerating PS 5 cm H2O) or a tracheostomy has been performed

Protocolized noninvasive weaning arm: Participants will be extubated and immediately provided with NIV with an equivalent level of PS and PEEP to the ventilator settings before extubation. After two hours, if no signs of distress/fatigue are observed, the NIV interface will be removed and the participant will undergo a self‐ventilation trial with supplemental oxygen (equivalent to the previous FiO2) via a standard oxygen mask. If no signs of distress or fatigue develop during the self ventilation trial, the participant will continue to receive unsupported ventilation, with inhaled oxygen provided as required. If the participant subsequently develops signs of distress or fatigue, NIV will be restarted (as below). Otherwise, the participant will continue with unsupported self ventilation. FiO2 will be titrated to maintain SaO2 > 90%. If signs of distress or fatigue develop, NIV will be reinstated at the previous settings. The level of PS will be titrated to achieve participant comfort and a RR < 30 breaths/min. Causes for distress/fatigue/weaning failure will be sought and corrective treatments initiated as appropriate. The participant will be reassessed every two hours. If no signs of distress/fatigue are noted, a further trial of self ventilation will be commenced as described above. NIV will be withdrawn when the participant tolerates 12 hours of unsupported spontaneous ventilation

In both groups, the active weaning protocol will occur between 8 am and 10 pm. Unless participants develop signs of fatigue or distress, ventilator settings will not be adjusted overnight

Outcomes

Primary: time from randomization to liberation from ventilation

Secondary

Efficacy:

1. Mortality at 30, 90 and 180 days

2. Duration of invasive mechanical ventilation and total ventilator‐free days (invasive and noninvasive ventilation)

3. Time to meeting ICU discharge criteria (defined as no further requirement for level 2/3 care)

4. Proportion of participants receiving antibiotics for presumed respiratory infection and total antibiotic days

5. Reintubation rates (protocolized end point and actual events)

6. Tracheostomy

Safety

1. Adverse events

2. Serious adverse events

Patient‐focused outcomes

Health‐related quality of life, EuroQol, EQ‐5D and SF12 at baseline (estimated) and at three and six months

Starting date

1 January 2013

Contact information

Mrs Beverley Hoddell, Clinical Trials Unit, Warwick Medical School, Gibbet Hill Road, Coventry, UK

[email protected]

Notes

Smith 2013

Trial name or title

NEXT: Comparison of noninvasive positive pressure ventilation for extubated patients who fail a single spontaneous breathing trial versus conventional weaning

Methods

RCT

(n = 8)

Stopped early because of the need to fulfil clinical requirements at another hospital

Participants

Inclusion criteria:

1. Participants will have to meet the criteria for reducing breathing support—will not be weaned until physiologically ready

2. Participants will have to be on a breathing machine attached to a tube in the mouth for at least 48 hours (participants who are on a breathing machine for < 48 hours are not seen as difficult to wean from a ventilator)

3. Age > 18 years—participant should be able to make own legal judgements regarding treatment

4. Written informed consent obtained

5. Failed an attempt to try breathing without help

Exclusion criteria:

1. Participants are generally not suitable for NIV (grade 3/4 intubation)

2. Gastric/oesophageal surgery on this admission

3. Participants who would not be ready for reintubation once extubated (by investigator decision????)

Interventions

Noninvasive positive‐pressure ventilation versus conventional weaning

Outcomes

Primary outcome: duration of time with breathing support tube in the mouth in days

Secondary outcomes: length of stay in the intensive care unit and hospital stay in days

Starting date

13 March 2006

Contact information

Dr Fang Gao

Department of Anaesthetics, Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust, Bordelsey Green East, Birmingham, UK

Notes

MV: mechanical ventilation; GCS: Glasgow Coma Scale; PaO2/FiO2: ratio of arterial partial pressure of oxygen to fractional concentration of inspired oxygen; PEEP: positive end‐expiratory pressure; SBT: spontaneous breathing trial; PS: pressure support; NPPV: noninvasive positive‐pressure ventilation; VAP: ventilator‐associated pneumonia; ICU: intensive care unit; LOS: length of stay.

Data and analyses

Open in table viewer
Comparison 1. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

16

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Noninvasive versus invasive weaning, Outcome 1 Mortality.

Comparison 1 Noninvasive versus invasive weaning, Outcome 1 Mortality.

1.1 COPD

9

632

Risk Ratio (M‐H, Random, 95% CI)

0.36 [0.24, 0.56]

1.2 Mixed

7

362

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.47, 1.40]

Open in table viewer
Comparison 2. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 2.1

Comparison 2 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

Comparison 2 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

1.1 COPD

3

351

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.36, 0.74]

1.2 Mixed

5

254

Risk Ratio (M‐H, Random, 95% CI)

0.73 [0.35, 1.51]

Open in table viewer
Comparison 3. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Nosocomial pneumonia Show forest plot

14

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 3.1

Comparison 3 Noninvasive versus invasive weaning, Outcome 1 Nosocomial pneumonia.

Comparison 3 Noninvasive versus invasive weaning, Outcome 1 Nosocomial pneumonia.

1.1 COPD

9

632

Risk Ratio (M‐H, Random, 95% CI)

0.22 [0.13, 0.37]

1.2 Mixed

5

321

Risk Ratio (M‐H, Random, 95% CI)

0.38 [0.15, 0.93]

Open in table viewer
Comparison 4. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 LOS ICU Show forest plot

13

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 4.1

Comparison 4 Noninvasive versus invasive weaning, Outcome 1 LOS ICU.

Comparison 4 Noninvasive versus invasive weaning, Outcome 1 LOS ICU.

1.1 COPD

8

608

Mean Difference (IV, Random, 95% CI)

‐6.66 [‐9.41, ‐3.92]

1.2 Mixed

5

299

Mean Difference (IV, Random, 95% CI)

‐3.32 [‐6.78, 0.15]

Open in table viewer
Comparison 5. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 LOS hospital Show forest plot

10

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 5.1

Comparison 5 Noninvasive versus invasive weaning, Outcome 1 LOS hospital.

Comparison 5 Noninvasive versus invasive weaning, Outcome 1 LOS hospital.

1.1 COPD

6

524

Mean Difference (IV, Random, 95% CI)

‐6.91 [‐10.83, ‐1.00]

1.2 Mixed

4

279

Mean Difference (IV, Random, 95% CI)

‐4.02 [‐9.41, 1.36]

Open in table viewer
Comparison 6. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average total duration of mechanical ventilatory support Show forest plot

7

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 6.1

Comparison 6 Noninvasive versus invasive weaning, Outcome 1 Average total duration of mechanical ventilatory support.

Comparison 6 Noninvasive versus invasive weaning, Outcome 1 Average total duration of mechanical ventilatory support.

1.1 COPD

5

277

Mean Difference (IV, Random, 95% CI)

‐5.77 [‐10.64, ‐0.91]

1.2 Mixed

2

108

Mean Difference (IV, Random, 95% CI)

‐5.20 [‐11.34, 0.93]

Open in table viewer
Comparison 7. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average duration of ventilation related to weaning Show forest plot

9

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 7.1

Comparison 7 Noninvasive versus invasive weaning, Outcome 1 Average duration of ventilation related to weaning.

Comparison 7 Noninvasive versus invasive weaning, Outcome 1 Average duration of ventilation related to weaning.

1.1 COPD

4

355

Mean Difference (IV, Random, 95% CI)

‐1.43 [‐3.12, 0.26]

1.2 Mixed

5

290

Mean Difference (IV, Random, 95% CI)

0.17 [‐4.01, 4.35]

Open in table viewer
Comparison 8. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Duration of endotracheal mechanical ventilation Show forest plot

12

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 8.1

Comparison 8 Noninvasive versus invasive weaning, Outcome 1 Duration of endotracheal mechanical ventilation.

Comparison 8 Noninvasive versus invasive weaning, Outcome 1 Duration of endotracheal mechanical ventilation.

1.1 COPD

7

558

Mean Difference (IV, Random, 95% CI)

‐7.53 [‐11.47, ‐3.60]

1.2 Mixed

5

159

Mean Difference (IV, Random, 95% CI)

‐6.85 [‐10.75, ‐2.95]

Open in table viewer
Comparison 9. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Reintubation Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 9.1

Comparison 9 Noninvasive versus invasive weaning, Outcome 1 Reintubation.

Comparison 9 Noninvasive versus invasive weaning, Outcome 1 Reintubation.

1.1 COPD

3

430

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.35, 0.70]

1.2 Mixed

7

359

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.47, 1.43]

Open in table viewer
Comparison 10. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Arrhythmia Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 10.1

Comparison 10 Noninvasive versus invasive weaning, Outcome 1 Arrhythmia.

Comparison 10 Noninvasive versus invasive weaning, Outcome 1 Arrhythmia.

1.1 COPD

1

30

Risk Ratio (M‐H, Random, 95% CI)

2.0 [0.20, 19.78]

1.2 Mixed

2

171

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.26, 2.17]

Open in table viewer
Comparison 11. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tracheostomy Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 11.1

Comparison 11 Noninvasive versus invasive weaning, Outcome 1 Tracheostomy.

Comparison 11 Noninvasive versus invasive weaning, Outcome 1 Tracheostomy.

1.1 COPD

1

264

Risk Ratio (M‐H, Random, 95% CI)

0.04 [0.00, 0.60]

1.2 Mixed

6

308

Risk Ratio (M‐H, Random, 95% CI)

0.23 [0.09, 0.57]

Open in table viewer
Comparison 12. Sensitivity analysis: noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality excluding quasi‐randomized trial Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 12.1

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 1 Mortality excluding quasi‐randomized trial.

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 1 Mortality excluding quasi‐randomized trial.

2 Nosocomial pneumonia excluding quasi‐randomized trial Show forest plot

13

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 12.2

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia excluding quasi‐randomized trial.

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia excluding quasi‐randomized trial.

Open in table viewer
Comparison 13. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality greater than or equal to 50% COPD versus less than 50% COPD Show forest plot

16

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 13.1

Comparison 13 Noninvasive versus invasive weaning, Outcome 1 Mortality greater than or equal to 50% COPD versus less than 50% COPD.

Comparison 13 Noninvasive versus invasive weaning, Outcome 1 Mortality greater than or equal to 50% COPD versus less than 50% COPD.

1.1 Greater than or equal to 50% COPD

12

846

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.29, 0.76]

1.2 Less than 50% COPD

4

148

Risk Ratio (M‐H, Random, 95% CI)

0.86 [0.47, 1.58]

Open in table viewer
Comparison 14. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure greater than or equal to 50% COPD Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 14.1

Comparison 14 Noninvasive versus invasive weaning, Outcome 1 Weaning failure greater than or equal to 50% COPD.

Comparison 14 Noninvasive versus invasive weaning, Outcome 1 Weaning failure greater than or equal to 50% COPD.

1.1 Greater than or equal to 50% COPD

5

522

Risk Ratio (M‐H, Random, 95% CI)

0.68 [0.46, 1.01]

1.2 Less than 50% COPD

3

83

Risk Ratio (M‐H, Random, 95% CI)

0.51 [0.12, 2.18]

Open in table viewer
Comparison 15. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.1

Comparison 15 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

Comparison 15 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

2 Nosocomial pneumonia Show forest plot

14

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.2

Comparison 15 Noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia.

Comparison 15 Noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia.

3 Average duration of ventilation related to weaning Show forest plot

9

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 15.3

Comparison 15 Noninvasive versus invasive weaning, Outcome 3 Average duration of ventilation related to weaning.

Comparison 15 Noninvasive versus invasive weaning, Outcome 3 Average duration of ventilation related to weaning.

4 Reintubation Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 15.4

Comparison 15 Noninvasive versus invasive weaning, Outcome 4 Reintubation.

Comparison 15 Noninvasive versus invasive weaning, Outcome 4 Reintubation.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Noninvasive versus invasive weaning, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Noninvasive versus invasive weaning, Outcome 1 Mortality.

Comparison 2 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.
Figuras y tablas -
Analysis 2.1

Comparison 2 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

Comparison 3 Noninvasive versus invasive weaning, Outcome 1 Nosocomial pneumonia.
Figuras y tablas -
Analysis 3.1

Comparison 3 Noninvasive versus invasive weaning, Outcome 1 Nosocomial pneumonia.

Comparison 4 Noninvasive versus invasive weaning, Outcome 1 LOS ICU.
Figuras y tablas -
Analysis 4.1

Comparison 4 Noninvasive versus invasive weaning, Outcome 1 LOS ICU.

Comparison 5 Noninvasive versus invasive weaning, Outcome 1 LOS hospital.
Figuras y tablas -
Analysis 5.1

Comparison 5 Noninvasive versus invasive weaning, Outcome 1 LOS hospital.

Comparison 6 Noninvasive versus invasive weaning, Outcome 1 Average total duration of mechanical ventilatory support.
Figuras y tablas -
Analysis 6.1

Comparison 6 Noninvasive versus invasive weaning, Outcome 1 Average total duration of mechanical ventilatory support.

Comparison 7 Noninvasive versus invasive weaning, Outcome 1 Average duration of ventilation related to weaning.
Figuras y tablas -
Analysis 7.1

Comparison 7 Noninvasive versus invasive weaning, Outcome 1 Average duration of ventilation related to weaning.

Comparison 8 Noninvasive versus invasive weaning, Outcome 1 Duration of endotracheal mechanical ventilation.
Figuras y tablas -
Analysis 8.1

Comparison 8 Noninvasive versus invasive weaning, Outcome 1 Duration of endotracheal mechanical ventilation.

Comparison 9 Noninvasive versus invasive weaning, Outcome 1 Reintubation.
Figuras y tablas -
Analysis 9.1

Comparison 9 Noninvasive versus invasive weaning, Outcome 1 Reintubation.

Comparison 10 Noninvasive versus invasive weaning, Outcome 1 Arrhythmia.
Figuras y tablas -
Analysis 10.1

Comparison 10 Noninvasive versus invasive weaning, Outcome 1 Arrhythmia.

Comparison 11 Noninvasive versus invasive weaning, Outcome 1 Tracheostomy.
Figuras y tablas -
Analysis 11.1

Comparison 11 Noninvasive versus invasive weaning, Outcome 1 Tracheostomy.

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 1 Mortality excluding quasi‐randomized trial.
Figuras y tablas -
Analysis 12.1

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 1 Mortality excluding quasi‐randomized trial.

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia excluding quasi‐randomized trial.
Figuras y tablas -
Analysis 12.2

Comparison 12 Sensitivity analysis: noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia excluding quasi‐randomized trial.

Comparison 13 Noninvasive versus invasive weaning, Outcome 1 Mortality greater than or equal to 50% COPD versus less than 50% COPD.
Figuras y tablas -
Analysis 13.1

Comparison 13 Noninvasive versus invasive weaning, Outcome 1 Mortality greater than or equal to 50% COPD versus less than 50% COPD.

Comparison 14 Noninvasive versus invasive weaning, Outcome 1 Weaning failure greater than or equal to 50% COPD.
Figuras y tablas -
Analysis 14.1

Comparison 14 Noninvasive versus invasive weaning, Outcome 1 Weaning failure greater than or equal to 50% COPD.

Comparison 15 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.
Figuras y tablas -
Analysis 15.1

Comparison 15 Noninvasive versus invasive weaning, Outcome 1 Weaning failure.

Comparison 15 Noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia.
Figuras y tablas -
Analysis 15.2

Comparison 15 Noninvasive versus invasive weaning, Outcome 2 Nosocomial pneumonia.

Comparison 15 Noninvasive versus invasive weaning, Outcome 3 Average duration of ventilation related to weaning.
Figuras y tablas -
Analysis 15.3

Comparison 15 Noninvasive versus invasive weaning, Outcome 3 Average duration of ventilation related to weaning.

Comparison 15 Noninvasive versus invasive weaning, Outcome 4 Reintubation.
Figuras y tablas -
Analysis 15.4

Comparison 15 Noninvasive versus invasive weaning, Outcome 4 Reintubation.

Summary of findings for the main comparison. Noninvasive versus invasive weaning for intubated adults with respiratory failure

Noninvasive versus invasive weaning for intubated adults with respiratory failure

Patient or population: intubated adults with respiratory failure
Settings:
Intervention: noninvasive versus invasive weaning

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

Noninvasive versus invasive weaning

MortalityCOPD

Study population

RR 0.36
(0.24 to 0.56)

632
(9 studies)

⊕⊕⊕⊝
moderate1

225 per 1000

81 per 1000
(54 to 126)

Moderate

200 per 1000

72 per 1000
(48 to 112)

Mortalitymixed

Study population

RR 0.81
(0.47 to 1.4)

362
(7 studies)

⊕⊕⊝⊝
low1

239 per 1000

194 per 1000
(112 to 335)

Moderate

270 per 1000

219 per 1000
(127 to 378)

*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.

1Fewer than 300 events.

Test for subgroup differences (P = 0.02).

Figuras y tablas -
Summary of findings for the main comparison. Noninvasive versus invasive weaning for intubated adults with respiratory failure
Summary of findings 2. Noninvasive versus invasive weaning for intubated adults with respiratory failure

Noninvasive versus invasive weaning for intubated adults with respiratory failure

Patient or population: patients with intubated adults with respiratory failure
Settings:
Intervention: Noninvasive versus invasive weaning

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

Noninvasive versus invasive weaning

Weaning failure

Study population

RR 0.63
(0.42 to 0.96)

605
(8 studies)

⊕⊕⊕⊝
moderate1

362 per 1000

228 per 1000
(152 to 348)

Moderate

327 per 1000

206 per 1000
(137 to 314)

Nosocomial pneumonia

Study population

RR 0.25
(0.15 to 0.43)

953
(14 studies)

⊕⊕⊝⊝
low2

296 per 1000

74 per 1000
(44 to 127)

Moderate

307 per 1000

77 per 1000
(46 to 132)

Average duration of ventilation related to weaning

The mean average duration of ventilation related to weaning in the intervention groups was
0.25 lower
(2.06 lower to 1.56 higher)

645
(9 studies)

⊕⊕⊝⊝
low3,4,5

Reintubation

Study population

RR 0.65
(0.44 to 0.97)

789
(10 studies)

⊕⊕⊕⊝
moderate1

310 per 1000

202 per 1000
(137 to 301)

Moderate

286 per 1000

186 per 1000
(126 to 277)

*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 Less than 300 events
2 RR 0.25 (95% CI 0.15 to 0.43)
3 Impact of heterogeneity was considerable (I2 =90%)
4 95% CI spans from a clinically important and significant increase or decrease
5 Uncertain if estimates include non‐survivors due to differential between group mortality (higher in control arm)

Figuras y tablas -
Summary of findings 2. Noninvasive versus invasive weaning for intubated adults with respiratory failure
Table 1. Populations and interventions in studies of noninvasive ventilation in critically ill adults

Study

No of participants

Inclusion criteria (participants)

Inclusion criteria

(weaning eligibility)

Experimental strategy

Control strategy

Nava

1998

50

Exacerbation of COPD. Intubated for at least 36 to 48 hours

Simple weaning criteria, 1‐hour SBT failure

Noninvasive pressure support on conventional ventilator delivered with face mask

Invasive PS

Girault 1999

33

Acute‐on‐chronic respiratory failure (COPD, restrictive, or mixed populations). Intubated for at least 48 hours

Simple weaning criteria, 2‐hour SBT failure

Flow or pressure mode with nasal or face mask

Flow or pressure mode (PS)

Hill

2000

21

Acute respiratory failure

30‐minute SBT failure

NPPV using VPAP in ST‐A mode

Invasive PS

 

Chen

 2001

 

24

 

Exacerbation of COPD. Intubated for at least 48 to 60 hours. Saturation > 88% on FiO2 of 40%

 

Day 3+ weaning criteria

 

Bilevel NPPV (pressure mode)

 

Invasive PS

Ferrer 2003

43

Acute respiratory failure and persistent weaning failure. Intubated for at least 72 hours

Two‐hour SBT failure on 3 consecutive days

Bilevel NPPV in ST mode delivered with face or nasal mask

AC or invasive PS

Rabie Agmy

 2004

37

Exacerbation of COPD

Two‐hour SBT failure

NPPV (proportional assist in timed mode) delivered by face or nasal mask

Invasive PS

Wang 2004

28

COPD. Bronchopulmonary infection

PIC window

NPPV (pressure mode) delivered by mask (unspecified)

 

SIMV + PS

Zheng

2005

33

COPD. Severe pulmonary infection

PIC window

Bilevel NPPV (pressure mode) delivered by face or nasal mask

Invasive PS

Zou

2006

76

COPD with severe respiratory failure. Pulmonary infection

PIC window

Bilevel NPPV (pressure, ST mode) delivered by nasal or oronasal mask

SIMV + PS

Wang

2005

90

COPD with severe hypercapneic respiratory failure. Pneumonia or purulent bronchitis. Age < 85. Capable of self care in past year

PIC window

Bilevel NPPV (pressure mode)

SIMV + PS

Trevisan 2008

65

Invasively ventilated > 48 hours

30‐minute SBT failure

Bilevel NPPV (pressure mode) delivered by face mask

Invasive mechanical ventilation

Prasad 2009

30

COPD. Hypercapneic respiratory failure

Two‐hour SBT failure

Bilevel NPPV (pressure mode) delivered by full face mask

Invasive PS

Girault 2011

138

Chronic hypercapneic respiratory failure invasively ventilated for at least 48 hours

Two‐hour SBT failure

Noninvasive PS ± PEEP or bilevel NIV with face mask (initial choice)

Invasive PS with once‐daily SBT with T‐piece or PS ± PEEP

Rabie Agmy

2012

264

Acute‐on‐chronic exacerbation of COPD

 

Two‐hour SBT failure

 

NPPV (pressure, ST mode)

Invasive PS

Tawfeek

2012

42

Invasively ventilated for > 48 hours

 

Two‐hour SBT failure

 

Noninvasive PAV ventilation delivered by face mask

SIMV

Vaschetto 2012

20

Hypoxemic respiratory failure invasively ventilated for at least 48 hours

PS  with PEEP + inspiratory support, < 25 cm H2O

 

PEEP 8 to 13 cm H2O

 

PaO2/FiO2 200 to 300 mm Hg with FiO2< 0.6

Helmet NPPV

Invasive PS with SBT when P/F ratio > 250 mm Hg

COPD = chronic obstructive pulmonary disease; NPPV = noninvasive positive‐pressure ventilation; PS = pressure support; PEEP = positive end‐expiratory pressure; PIC = pulmonary infection control window; ST = spontaneous timed; AC = assist control; SIMV = synchronized intermittent mandatory ventilation; P/F ratio = ratio of arterial concentration of oxygen to fractional concentration of oxygen administered; SBT = spontaneous breathing trial; PAV = proportional assist ventilation.

Figuras y tablas -
Table 1. Populations and interventions in studies of noninvasive ventilation in critically ill adults
Comparison 1. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

16

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

9

632

Risk Ratio (M‐H, Random, 95% CI)

0.36 [0.24, 0.56]

1.2 Mixed

7

362

Risk Ratio (M‐H, Random, 95% CI)

0.81 [0.47, 1.40]

Figuras y tablas -
Comparison 1. Noninvasive versus invasive weaning
Comparison 2. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

3

351

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.36, 0.74]

1.2 Mixed

5

254

Risk Ratio (M‐H, Random, 95% CI)

0.73 [0.35, 1.51]

Figuras y tablas -
Comparison 2. Noninvasive versus invasive weaning
Comparison 3. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Nosocomial pneumonia Show forest plot

14

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

9

632

Risk Ratio (M‐H, Random, 95% CI)

0.22 [0.13, 0.37]

1.2 Mixed

5

321

Risk Ratio (M‐H, Random, 95% CI)

0.38 [0.15, 0.93]

Figuras y tablas -
Comparison 3. Noninvasive versus invasive weaning
Comparison 4. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 LOS ICU Show forest plot

13

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 COPD

8

608

Mean Difference (IV, Random, 95% CI)

‐6.66 [‐9.41, ‐3.92]

1.2 Mixed

5

299

Mean Difference (IV, Random, 95% CI)

‐3.32 [‐6.78, 0.15]

Figuras y tablas -
Comparison 4. Noninvasive versus invasive weaning
Comparison 5. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 LOS hospital Show forest plot

10

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 COPD

6

524

Mean Difference (IV, Random, 95% CI)

‐6.91 [‐10.83, ‐1.00]

1.2 Mixed

4

279

Mean Difference (IV, Random, 95% CI)

‐4.02 [‐9.41, 1.36]

Figuras y tablas -
Comparison 5. Noninvasive versus invasive weaning
Comparison 6. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average total duration of mechanical ventilatory support Show forest plot

7

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 COPD

5

277

Mean Difference (IV, Random, 95% CI)

‐5.77 [‐10.64, ‐0.91]

1.2 Mixed

2

108

Mean Difference (IV, Random, 95% CI)

‐5.20 [‐11.34, 0.93]

Figuras y tablas -
Comparison 6. Noninvasive versus invasive weaning
Comparison 7. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average duration of ventilation related to weaning Show forest plot

9

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 COPD

4

355

Mean Difference (IV, Random, 95% CI)

‐1.43 [‐3.12, 0.26]

1.2 Mixed

5

290

Mean Difference (IV, Random, 95% CI)

0.17 [‐4.01, 4.35]

Figuras y tablas -
Comparison 7. Noninvasive versus invasive weaning
Comparison 8. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Duration of endotracheal mechanical ventilation Show forest plot

12

Mean Difference (IV, Random, 95% CI)

Subtotals only

1.1 COPD

7

558

Mean Difference (IV, Random, 95% CI)

‐7.53 [‐11.47, ‐3.60]

1.2 Mixed

5

159

Mean Difference (IV, Random, 95% CI)

‐6.85 [‐10.75, ‐2.95]

Figuras y tablas -
Comparison 8. Noninvasive versus invasive weaning
Comparison 9. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Reintubation Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

3

430

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.35, 0.70]

1.2 Mixed

7

359

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.47, 1.43]

Figuras y tablas -
Comparison 9. Noninvasive versus invasive weaning
Comparison 10. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Arrhythmia Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

1

30

Risk Ratio (M‐H, Random, 95% CI)

2.0 [0.20, 19.78]

1.2 Mixed

2

171

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.26, 2.17]

Figuras y tablas -
Comparison 10. Noninvasive versus invasive weaning
Comparison 11. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tracheostomy Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 COPD

1

264

Risk Ratio (M‐H, Random, 95% CI)

0.04 [0.00, 0.60]

1.2 Mixed

6

308

Risk Ratio (M‐H, Random, 95% CI)

0.23 [0.09, 0.57]

Figuras y tablas -
Comparison 11. Noninvasive versus invasive weaning
Comparison 12. Sensitivity analysis: noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality excluding quasi‐randomized trial Show forest plot

15

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2 Nosocomial pneumonia excluding quasi‐randomized trial Show forest plot

13

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 12. Sensitivity analysis: noninvasive versus invasive weaning
Comparison 13. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality greater than or equal to 50% COPD versus less than 50% COPD Show forest plot

16

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Greater than or equal to 50% COPD

12

846

Risk Ratio (M‐H, Random, 95% CI)

0.47 [0.29, 0.76]

1.2 Less than 50% COPD

4

148

Risk Ratio (M‐H, Random, 95% CI)

0.86 [0.47, 1.58]

Figuras y tablas -
Comparison 13. Noninvasive versus invasive weaning
Comparison 14. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure greater than or equal to 50% COPD Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Greater than or equal to 50% COPD

5

522

Risk Ratio (M‐H, Random, 95% CI)

0.68 [0.46, 1.01]

1.2 Less than 50% COPD

3

83

Risk Ratio (M‐H, Random, 95% CI)

0.51 [0.12, 2.18]

Figuras y tablas -
Comparison 14. Noninvasive versus invasive weaning
Comparison 15. Noninvasive versus invasive weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Weaning failure Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2 Nosocomial pneumonia Show forest plot

14

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3 Average duration of ventilation related to weaning Show forest plot

9

Mean Difference (IV, Random, 95% CI)

Subtotals only

4 Reintubation Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 15. Noninvasive versus invasive weaning