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Desconexión protocolizada versus no protocolizada para la reducción de la duración de la ventilación mecánica en pacientes adultos graves

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References

References to studies included in this review

Chaiwat 2010 {published data only (unpublished sought but not used)}

Chaiwat O, Sarima N, Niyompanitpattana K, Komoltri C, Udomphorn Y, Kongsayreepong S. Protocol‐directed vs. physician‐directed weaning from ventilator in intra‐abdominal surgical patients. Journal of Medical Association of Thailand 2010;93(8):930‐6. CENTRAL

de Carvalho Oliveira 2002 {published and unpublished data}

de Carvalho Oliveira LR, Jose A, Dias EC, dos Santos VLA, Chiavone PA. Weaning protocol for mechanical ventilation: effects of its use in an intensive care unit. A controlled, prospective and randomized trial. Revista Brasileira Terapia Intensiva 2002;14(1):22‐32. CENTRAL

Ely 1996 {published and unpublished data}

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(25):1864‐9. [PUBMED: 8948561]CENTRAL

Fan 2013 {published data only}

Fan L, Su H, Zhang Y, Zhang Y, Gao D, Ye H, et al. A randomized controlled trial of protocol‐directed versus physician‐directed weaning from mechanical ventilation in neuro‐critical patients. Chinese Journal of Neurology 2013;46(5):320‐3. CENTRAL

Kollef 1997 {published and unpublished data}

Kollef MH, Shapiro SD, Silver P, St John RE, Prentice D, Sauer S, et al. A randomized, controlled trial of protocol‐directed versus physician‐directed weaning from mechanical ventilation. Critical Care Medicine 1997;25(4):567‐74. [PUBMED: 9142019 ]CENTRAL

Krishnan 2004 {published and unpublished data}

Krishnan JA, Moore D, Robeson C, Rand CS, Fessler HE. A prospective, controlled trial of a protocol‐based strategy to discontinue mechanical ventilation. American Journal of Respiratory and Critical Care Medicine 2004;169(6):673‐8. [PUBMED: 14726421]CENTRAL

Marelich 2000 {published and unpublished data}

Marelich GP, Murin S, Battistella F, Inciardi J, Vierra T, Roby M. Protocol weaning of mechanical ventilation in medical and surgical patients by respiratory care practitioners and nurses: effect on weaning time and incidence of ventilator‐associated pneumonia. Chest 2000;118(2):459‐67. [PUBMED: 10936141]CENTRAL

Namen 2001 {published and unpublished data}

Namen AM, Ely EW, Tatter SB, Case LD, Lucia MA, Smith A, et al. Predictors of successful extubation in neurosurgical patients. American Journal of Respiratory and Critical Care Medicine 2001;163(3 Pt 1):658‐64. [PUBMED: 11254520 ]CENTRAL

Navalesi 2008 {published and unpublished data}

Navalesi P, Frigerio P, Moretti MP, Sommariva M, Vesconi S, Baiardi P, et al. Rate of reintubation in mechanically ventilated neurosurgical and neurologic patients: evaluation of a systematic approach to weaning and extubation. Critical Care Medicine 2008;36(11):2986‐92. [PUBMED: 18824909]CENTRAL

Ogica 2007 {published and unpublished data}

Ogica A, Droc G, Tomescu D, Popescu H, Tulbure D. Weaning from mechanical ventilation: protocol vs physician decision. European Journal of Anaesthesiology 2007;24:147‐8. CENTRAL

Piotto 2011 {published and unpublished data}

Piotto RF, Maia LN, Machado MN, Orrico SP. Effects of the use of mechanical ventilation weaning protocol in the coronary care unit: randomized study. Revista Brasileira de Cirurgia Cardiovascular 2011;26(2):213‐221. CENTRAL

Reardon 2011 {unpublished data only}

Reardon CC, Walkey AJ. Clinical trial of a computer‐driven weaning system for patients requiring mechanical ventilation. http://www.clinicaltrials.gov/2011. CENTRAL

Roh 2012 {published and unpublished data}

Roh JH, Synn A, Lim C, Suh HJ, Hong S, Huh JW, et al. A weaning protocol administered by critical care nurses for the weaning of patients from mechanical ventilation. Journal of Critical Care 2012;27(6):549‐55. CENTRAL

Rose 2008 {published data only}

Rose L, Presneill JJ, Johnston L, Cade JF. A randomised, controlled trial of conventional versus automated weaning from mechanical ventilation using SmartCare TM/PS. Intensive Care Medicine 2008;34(10):1788‐95. [PUBMED: 18575843 ]CENTRAL

Simeone 2002 {published and unpublished data}

Simeone F, Biagioli B, Scolletta S, Marullo ACM, Marchetti L, Caciorgna M, et al. Optimization of mechanical ventilation support following cardiac surgery. Journal of Cardiovascular Surgery 2002;43(5):633‐41. [PUBMED: 12386574 ]CENTRAL

Stahl 2009 {published and unpublished data}

Stahl C, Dahmen G, Ziegler A, Muhl E. Comparison of automated protocol‐based versus non‐protocol‐based physician‐directed weaning from mechanical ventilation. Intensivmedizin und Notfallmedizin 2009;46(6):441‐6. [DOI: 10.1007/s00390‐009‐0061‐0]CENTRAL

Strickland 1993 {published data only}

Strickland Jr JH, Hasson JH. A computer‐controlled, ventilator weaning system. A clinical trial. Chest 1993;103(4):1220‐6. [PUBMED: 8131469]CENTRAL

References to studies excluded from this review

Beale 2008 {unpublished data only}

Beale R. Comparison of an automated weaning programme and a standard clinical weaning protocol for weaning critically ill patients. ISRCTN Register. CENTRAL

Donglemans 2009 {published data only}

Donglemans DA, Veelo DP, Paulus F, de Mol BA, Korevar JC, Kudoga A, et al. Weaning automation with adaptive support ventilation: a randomized controlled trial in cardiothoracic surgery patients. Anesthesia and Analgesia 2009;108(2):565‐71. CENTRAL

East 1999 {published and unpublished data}

East TD, Heermann LK, Bradshaw RL, Lugo A, Sailors RM, Ershler L, et al. Efficacy of computerized decision support for mechanical ventilation: results of a prospective multi‐center randomized trial. Journal of the American Medical Informatics Association 1999;Suppl:251‐5. [PUBMED: 10566359 ]CENTRAL

Gnanapandithan 2011 {published data only}

Gnanapandithan K, Agarwal R, Aggarwal AN, Gupta D. Weaning by gradual pressure support (PS) reduction without an initial spontaneous breathing trial (SBT) versus PS‐supported SBT: a pilot study. Revista Portuguesa de Pneumologia 2011;17(6):244‐52. CENTRAL

Lellouche 2006 {published data only}

Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, et al. A multicenter randomized trial of computer‐driven protocolized weaning from mechanical ventilation. American Journal of Respiratory and Critical Care Medicine 2006;174:894‐900. CENTRAL

Liu 2013 {published data only}

Liu L, Xu XT, Yang Y, Huang YZ, Liu SQ, Qiu HB. Computer‐driven automated weaning reduces weaning duration in difficult‐to‐wean patients. Chinese Medical Journal 2013;126(10):1814‐18. [DOI: 10.3760/cma.j.issn.0366‐6999.20130380]CENTRAL

Ma 2010a {published data only}

Ma YM, Liu YN, Pan L. The effect of spontaneous breathing trial on weaning from ventilators. Chinese Journal of Tuberculosis and Respiratory Diseases 2010;33(3):179‐182. CENTRAL

Ma 2010b {published data only (unpublished sought but not used)}

Ma YJ, Yang XJ, Cao XY, Ma XG. Comparison of computer‐driven weaning and physician‐directed weaning from mechanical ventilation. Chinese Journal of Tuberculosis and Respiratory Diseases 2010;33(3):174‐178. CENTRAL

McKinley 2001 {published data only}

McKinley BA, Moore FA, Sailors RM, Cocanour CS, Marquez A, Wright RK, et al. Computerized decision support for mechanical ventilation of trauma induced ARDS: results of a randomized clinical trial. The Journal of Trauma Injury, Infection and Critical Care 2001;50(3):415‐24. [PUBMED: 11265020]CENTRAL

NCT00157287 {unpublished data only}

NCT00157287. A cluster randomized trial to improve weaning and extubation from mechanical ventilation in community hospitals. clinicaltrials.gov/ct2/show/NCT00157287 (accessed 30 January 2014). CENTRAL

NCT00445289 {unpublished data only}

NCT00445289. Automatic control of pressure support ventilation in surgical intensive care units. http://clinicaltrials.gov/show/NCT00445289 (accessed 30 January 2014). CENTRAL

NCT00502489 {unpublished data only}

NCT00502489. Computer driven management of weaning following prolonged mechanical ventilation. clinicaltrials.gov/show/NCT00502489 (accessed 30 January 2014). CENTRAL

Taniguchi 2009 {published data only}

Taniguchi C, Eid RC, Saghabi C, Souza R, Silva E, Knobel E, et al. Automatic versus manual pressure support reduction in the weaning of post‐operative patients: a randomised controlled trial. Critical Care 2009;13(1):R6. CENTRAL

Vaschetto 2011 {published data only (unpublished sought but not used)}

Vaschetto R, Levati A, Boggero A, Gollo Y, Moretti MP, Sommariva M, et al. Does a weaning protocol facilitate liberation from mechanical ventilation in tracheotomized brain‐injured patients?. Intensive Care Medicine. 2011; Vol. 37:S6. CENTRAL

Aitken 2012

Aitken LM, Bucknall T, Kent B, Mitchell M, Burmeister E, Keogh SJ. Protocol directed sedation versus non‐protocol directed sedation to reduce duration of mechanical ventilation in mechanically ventilated intensive care patients. Cochrane Database of Systematic Reviews 2012, Issue 4. [DOI: 10.1002/14651858.CD009771]

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Blackwood 2013

Blackwood B, Murray M, Chisakuta A, Cardwell CR, O’Halloran P. Protocolized versus non‐protocolized weaning for reducing the duration of invasive mechanical ventilation in critically ill paediatric patients. Cochrane Database of Systematic Reviews 2013, Issue 7. [DOI: 10.1002/14651858.CD009082.pub2]

Blackwood 2014

Blackwood B, Clarke M, McAuley DF, McGuigan P, Marshall JC, Rose L. How outcomes are defined in clinical trials of mechanically ventilated adults and children. American Journal of Respiratory and Critical Care Medicine 2014;189(8):886‐93. [PUBMED: 24512505]

Bland 1996

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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(4):896‐903. [PUBMED: 7921460]

Bucknall 2008

Bucknall TK, Manias E, Presneill JJ. A randomized trial of protocol‐directed sedation management for mechanical ventilation in an Australian intensive care unit. Critical Care Medicine 2008;36(5):1444‐50. [DOI: 10.1097/CCM.0b013e318168f82d.]

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Burns KEA, Lellouche F, Lessard MR. Automating the weaning process with advanced closed‐loop systems. Intensive Care Medicine 2008;34(10):1757‐65. [PUBMED: 18521570 ]

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Cook D, Meade M, Guyatt G, Griffith L, Booker L. Criteria for weaning from mechanical ventilation. Evidence Report/Technology Assessment No.23. AHRQ Publication No. 01‐E0052000. [PUBMED: 10932958]

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Esen 1992

Esen F, Denkel T, Telci L, Kesecioglu J, Tütüncü AS, Akpir K, et al. Comparison of pressure support ventilation (PSV) and intermittent mandatory ventilation (IMV) during weaning in patients with acute respiratory failure. Advances in Experimental Medical Biology 1992;317:371‐6. [PUBMED: 1288147]

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Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. New England Journal of Medicine 1995;332(6):345‐50. [MEDLINE: 7823995]

Esteban 2008

Esteban A, Ferguson ND, Meade MO, Frutos‐Vivar F, Apezteguia C, Brochard L, et al. Evolution of mechanical ventilation in response to clinical research. American Journal of Respiratory and Critical Care Medicine 2008;177(2):170‐7. [MEDLINE: 11790214]

Girard 2008

Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, et al. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet 2008;371(9607):126‐34. [DOI: 10.1016/S0140‐6736(08)60105‐1.]

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Hendrix 2006

Hendrix H, Kaiser ME, Yusen RD, Merk J. A randomized trial of automated versus conventional protocol‐driven weaning from mechanical ventilation following coronary artery bypass surgery. European Journal of Cardio‐thoracic Surgery 2006;29(6):957‐63. [PUBMED: 16520042]

Hess 2011

Hess DR, MacIntyre NR. Ventilator discontinuation: why are we still weaning?. American Journal of Respiratory and Critical Care Medicine 2011;184(4):392‐394. [DOI: 10.1164/rccm.201105‐0894ED]

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Higgins 2011a

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Higgins 2011b

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

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Jordan J, Rose L, Noyes J, Dainty KN, Blackwood B. Factors that impact on the use of mechanical ventilation weaning protocols in critically ill adults and children: a qualitative evidence‐synthesis. Cochrane Database of Systematic Reviews 2012, Issue 5. [DOI: 10.1002/14651858.CD009851]

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Kubler A, Maciejewski D, Adamik B, Kaczorowska M. Mechanical ventilation in ICUs in Poland: A multi‐center point‐prevalence study. Medical Science Monitor 2013;19:424‐9. [ISSN 1643‐3750]

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Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, et al. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. New England Journal of Medicine 2008;358(13):1327‐35. [PUBMED: 18367735 ]

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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;120 Suppl:375‐95.

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Mancebo J. Weaning from mechanical ventilation. European Respiratory Journal 1996;9(9):1923‐31. [PUBMED: 8880113]

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Rose 2013

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References to other published versions of this review

Blackwood 2008

Blackwood B, Alderdice F, Burns KE, Cardwell CR, Lavery G, O'Halloran P. Protocolized versus non‐protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients. Cochrane Database of Systematic Reviews 2008, Issue 1. [DOI: 10.1002/14651858.CD006904]

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Blackwood B, Alderdice F, Burns KE, Cardwell CR, Lavery G, O’Halloran P. Protocolized versus non‐protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients. Cochrane Database of Systematic Reviews 2010, Issue 5. [DOI: 10.1002/14651858.CD006904.pub2]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Chaiwat 2010

Methods

Randomized controlled trial

Participants

Setting: Bangkok, Thailand; academic hospital; surgical ICU 14 beds; physician staffing included one senior attending certified for critical care medicine or anaesthesia board; one junior attending. Additionally, 5‐6 trainees working 24 hours in ICU. Nurse staffing not reported, but stated they were under staffed

Participants: 100 adults (51 intervention group, 49 control group)

Conditions: general, urological, gynaecological or obstetric intra‐abdominal surgery

Inclusion: Intra‐abdominal surgical patients; intubated and receiving MV > 24 hours; ASA class I ‐ III. Exclusion: < 18 years; brain death; inability to obtain informed consent; mental retardation; perioperative myocardial infarction; morbid obesity

Interventions

Intervention: daily screen for readiness; SBT on PS 7 cmH2O and 5 cmH2O PEEP for 120 minutes; if successful ask attending for approval to extubate

Control: Weaning at the discretion of the managing physician

Outcomes

1. Duration of MV (primary) from tracheal intubation to discontinuation of MV or continued need for MV at day 21 after randomization

2. Reintubation within 72 hours after extubation

3. Need for MV > 21 days

Notes

Protocol registration not reported. ITT not reported. Sample size calculation based on 80% power to detect a mean (SD) difference in duration of MV between the two groups of 36 (120) hours, α 0.05, 176 patients per group. Four interim analyses planned at 4, 6, 8 months and end of study. Study terminated after the 6 month interim analysis (100 patients recruited)

Informed consent obtained

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Block randomization, size 4 and 6. Each assignment of weaning method was indicated on a data form, folded & sealed in opaque envelope, opened only after informed consent obtained"

Allocation concealment (selection bias)

Low risk

Sealed in opaque envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not reported, but impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

472 patients screened and 372 excluded due to exclusion criteria or not obtaining informed consent (no details reported)

Selective reporting (reporting bias)

Unclear risk

There was no protocol and ICU length of stay and mortality were not reported which would be usual in these studies

Other bias

Unclear risk

The paper reported that a priori interim analyses were planned and the study was terminated at 6 months by an independent committee. However the discussion states “The authors did the 1st and 2nd analyses of 100 patients & found significant outcomes so the authors decided to stop the present study earlier” P 934. For this reason we assessed the risk as unclear

de Carvalho Oliveira 2002

Methods

Randomized controlled trial

Participants

Setting: Sao Paulo, Brazil; single combined medical/surgical unit. Physician and nurse staffing not reported

Participants: 40 adults (20 intervention group, 20 control group)

Conditions: Not reported

Inclusion: medically fit ‐ decision of multidisciplinary team; receiving MV > 24 hours; APACHE II < 25. Exclusion: < 18 years; tracheostomy

Interventions

Intervention: algorithm that included readiness to wean criteria and a SBT on PS 7 cmH2O with PEEP 5 cmH2O for 120 minutes; if successful, extubated

Control: "Weaning without obeying strict procedures or criteria"

Outcomes

1. Weaning success (primary), no requirement for reintubation within 48 hours after extubation

2. Use of NIV postextubation

3. Total duration of MV

4. Weaning duration

5. Death

Notes

Protocol registration not reported. ITT not reported. Sample size calculation and ethical approval not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Selective reporting (reporting bias)

Unclear risk

There was no protocol, although usual outcomes for weaning studies reported

Other bias

Unclear risk

Appears to be free of other sources of bias

Ely 1996

Methods

Randomized controlled trial

Participants

Setting: USA; 806‐bed university medical centre. One medical and one coronary ICU. "Closed units staffed by intensivists". Staffing ‐ 3.5 physician hours/bed/day (Krishnan 2004). NURSE/RT staffing not reported

Participants: 300 adults (149 intervention, 151 control)

Conditions: CHF; heart disease; COPD/asthma; pneumonia; ARDS/MSOF; GI and liver disease; cancer/leukaemia; overdose/ketoacidosis; neurologic emergency

Inclusion:18 years and older; intubated and mechanically ventilated. Exclusions: 18 years; lack of informed consent; extubation order at time of evaluation; dependence on MV 2 weeks before recruitment

Interventions

Intervention: protocol delivered by RNs and RTs consisting of daily screening of readiness to wean using 5 criteria; a 2‐hour SBT; and notification of the physician of successful SBT

Control: usual practice consisting of weaning according to physician judgement

Outcomes

1. Total duration of mechanical ventilation (primary)

2. Weaning duration (time from successful screening test to discontinuation of MV) (primary)

3. ICU length of stay (primary)

4. Adverse events (reintubation; self‐extubation; tracheostomy; MV > 21 days)

5. Cost of respiratory care, intensive care and hospitalisation

6. Hospital length of stay

7. Mortality

Notes

ITT analysis performed. Sample size calculation not reported. Study approved by hospital Institutional Review Board and informed consent required. The primary author supplied additional data

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computerized randomization

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"All of the data were collected by research personnel not involved in the patients' care"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data. Recruitment and attrition data presented. Analyses performed using ITT principle

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias

Fan 2013

Methods

Randomized controlled trial

Participants

Setting; China, neurosurgical ICU in an academic hospital

Participants: 65 enrolled (intervention 32; control 33). 5 withdrawn following randomization, group attrition numbers not reported

Inclusion: Respiratory or pulmonary failure; age 18‐85 years; mechanically ventilated >/= 24 hours

Exclusion: motor neuron disease of other nervous system disease; mechanically ventilated > 2 weeks; patients who gave up ventilation; patients not expected to survive > 6 months

Interventions

Intervention: Patients were assessed by screening test once per day. The patients who did not pass the test were treated with mechanical ventilation and continued screening test. The patients who passed the test were assessed by 30 minute spontaneous breathing trial. The patients who passed the SBT would withdraw from mechanical ventilation. The patients who did not pass the SBT would be ventilated by SIMV + PSV, and ventilator parameters were gradually reduced every 4 hours; the respiratory frequency was decreased 2/breaths every 4 hours, until 4/breaths; the pressure support was decreased 2 cmH2O every 4 hours, until 7 cmH2O. SBT was conducted once per day. The patients who passed the SBT or when the respiratory frequency was maintained as 4/breaths and pressure support was maintained as 7 cmH2O would withdraw from mechanical ventilation

Control: usual practice by physicians, not described

Outcomes

1. Total duration of mechanical ventilation

2. Weaning duration

3. ICU length of stay

4. Cost

5. ICU mortality

6. VAP incidence

7. Weaning success

Notes

Paper was translated from Chinese to English. Authors were contacted (in Chinese) to supply standard deviations, but we received no response

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table used

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not reported, but not possible

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition numbers reported in both groups

Selective reporting (reporting bias)

Unclear risk

Insufficient information

Other bias

Unclear risk

Insufficient information

Kollef 1997

Methods

Randomized controlled trial

Participants

Setting: USA, 2 medical and 2 surgical ICUs in 2 university affiliated teaching hospitals (900 and 450‐beds). Nurse to patient ratio 1:2 and 4.0 physician hours/bed/day (Krishnan 2004)

Participants: 357 adults (intervention 179, control 178)

Conditions: postoperative; trauma; pneumonia; COPD/asthma; pulmonary oedema; respiratory failure; drug overdose; cardiac arrest/cardiogenic shock

Inclusion: mechanically ventilated. Exclusions: head/facial burns or trauma; transfer from other hospital with prior MV; brain death

Interventions

Intervention: protocol entry criteria assessed, then protocol delivered by RNs and RTs consisting of:

a) ICUs 1 and 4 ‐ daily SBTs through ventilator circuit with CPAP ≤ 5 cmH2O and PS ≤ 6 cmH20 for 30‐60 minutes then extubation

b) ICU 2 ‐ stepwise reductions of 2 cmH20 in PSV until 6 cmH20 then extubation

c) ICU 3 ‐ on PEEP ≤ 5 cmH20, PS ≤ 6 cmH20, stepwise IMV reductions of 2 breaths/min until ≤4 breaths/min, then 0 breaths for 30‐60 minutes, then extubation

Control: usual practice consisting of weaning according to physician judgement

Outcomes

1. Total duration of mechanical ventilation from intubation until discontinuation of MV

2. Reintubation

3. Length of hospital stay

4. Hospital mortality rate

5. Hospital costs

6. MV time prior to weaning

7. Requiring MV for > 7 days

Notes

Protocol registration not reported. Sample size calculation based on 80% power to detect a difference in weaning time of 1 (SD 3) days, α 0.05, 145 patients needed per group. Study approved by University Human Studies Committee and hospital Institutional Review Board ‐ both waived requirement for informed consent

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Seperate blocked randomization schedules

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors were independent from the individuals administering/supervising the intervention

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data.Recruitment & attrition data presented. Analyses performed using ITT principle

Selective reporting (reporting bias)

Low risk

Weaning protocol is available; all prespecified outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias. Sample size calculation stated (based on 80% power to detect a 1 day difference in weaning time, α 0.05, 145 required for each group)

Krishnan 2004

Methods

Quasi‐randomized controlled trial

Participants

Setting: USA, 1000‐bed hospital. 14 bed medical ICU; nurse to patient ratio 1:2; 9.5 physician hours/bed/day. 1‐2 RTs. Daily bedside rounds Medical cover at night

Participants: 299 adults (intervention 154, control 145)

Conditions: cardiopulmonary arrest; pneumonia/acute lung injury; COPD/asthma; cardiogenic pulmonary oedema; neurologic emergency

Inclusion: mechanically ventilated > 24 hours

Exclusions: previous participants; enrolled in other studies; transferred from other facilities intubated

Interventions

Intervention: protocol delivered by RNs and RTs consisting of daily screening of readiness to wean using 5 criteria; a 1‐hour SBT on CPAP 5 cmH20; and notification of the physician of successful SBT

Control: usual practice consisting of weaning according to physician judgement

Outcomes

1. Total duration of MV (time from start of MV to beginning of SBT that ended with successful discontinuation of MV)

2. Duration of SBT that preceded MV discontinuation

3. ICU length of stay

4. Location after ICU discharge

5. ICU and hospital mortality

6. Reinstitution of MV (< 48 hours & > 48 hours)

Notes

Protocol registration not reported. Successful discontinuation was unassisted breathing for 48 hours. Analyses based on ITT. The sample size (? post hoc) provided 82% power to detect a difference in duration of MV of 1 day, α 0.05. Study approved by Institutional Review Board ‐ waived requirement for informed consent

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Assigned by hospital number (odd versus even)

Allocation concealment (selection bias)

High risk

Case record number

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Unclear whether outcome assessors were independent from those making decisions. RNs and RTs recorded results of screening and SBTs on case report forms. Study coordinator documented other data

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data. Recruitment and attrition data presented. ITT analysis performed

Selective reporting (reporting bias)

Low risk

Weaning protocol is available; all prespecified outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias

Marelich 2000

Methods

Randomized controlled trial

Participants

Setting: USA, 1 university medical centre. 3 ICUs with medical and trauma/surgical services; RT to ventilator ratio 1:7; nurse to patient ratio 1:1 or 1:2; 4.7 physician hours/bed/day

Participants: 335 adults (intervention 166, control 169)

Conditions: postoperative trauma; non‐operative trauma; pneumonia; neurologic emergency; poisoning; GI bleed/liver; COPD/asthma; respiratory failure; metabolic/renal; CHF

Inclusion: mechanically ventilated. Exclusions: pregnancy; < 18 years; mentally disabled; prisoners

Interventions

Intervention: protocol delivered by RNs and RTs consisting of twice daily screening of readiness to wean; a 30‐minute SBT (< 72 hours ventilated) or stepwise reduction in PEEP, PS and IMV (> 72 hours ventilated); and notification of the physician of successful SBT

Control: usual practice consisting of weaning according to physician judgement on MICU; and a standardized MD approach on trauma services consisting of gradual reductions in IMV, then PS, then SBTs administered (but extubation was based on subjective opinion)

Outcomes

1. Total duration of MV (primary)

2. Incidence of VAP (primary)

3. Weaning duration (duration of MV from study entry to discontinuation of ventilator support)

4. Duration of MV from initiation of mechanical support to meeting discontinuation criteria

5. Ventilator discontinuation failure rate

6. Tracheostomy

7. Hospital mortality

Notes

Protocol registration not reported. Sample size calculation based on 80% power to detect a difference in time to ventilator discontinuation of 1.5 days, α 0.05, but patient numbers required not reported. Study approved by University Human Subjects Review Committee ‐ requirement for informed consent waived

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Stratified according to medical or surgical, put into envelopes and shuffled

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Outcome assessors independent from those involved in intervention

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data. Recruitment and attrition data presented

Selective reporting (reporting bias)

Low risk

Weaning protocol is available; all prespecified outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias

Namen 2001

Methods

Randomized controlled trial

Participants

Setting: USA. Hospital and units not specified. Staffing ratios not stated

Participants: 100 neurosurgical adult patients (intervention 49, control 51)

Conditions: head trauma; subarachnoid haemorrhage; intracerebral haemorrhage/arteriovenous malformation; tumour; spinal trauma

Inclusion: mechanically ventilated. Exclusions not stated

Interventions

Intervention: RT‐focused protocol consisting of daily screening of readiness to wean; a 2‐hour SBT; and notification of the physician of successful SBT

Control: not stated

Outcomes

1. Total duration of MV (primary)

2. ICU length of stay (primary)

3. Time to successful extubation (primary)

4. Adverse events (reintubation; self‐extubation; tracheostomy, MV exceeding 21 days)

5. Costs of MV, respiratory and ICU care & overall hospitalisation

6. Hospital length of stay

7. Mortality

8. Existence of pneumonia

Notes

Protocol registration not reported. ITT analysis performed. Study powered for 188 patients (80% power, α 0.05) to detect a 20% difference in duration of MV. Study approved by hospital Institutional Review Board and informed consent required

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not described

Allocation concealment (selection bias)

Unclear risk

Not described

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not described

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data. Recruitment and attrition data presented. ITT analysis performed

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported

Other bias

Unclear risk

Trial stopped early for futility. Study powered for 188 patients. Planned interim analysis at 12‐months showed lack of efficacy, study stopped at 100 patients

Navalesi 2008

Methods

Randomized controlled trial

Participants

Setting: Italy, 1200 bed hospital. Closed neuro‐ICU, 9 bed unit. Nurse to patient ratio 1:2; 24‐hour physicians certified and trained in anaesthesiology and critical care. 1 RT

Participants: 318 adult neurosurgical and neurological patients (165 intervention group; 153 control group)

Conditions: subarachnoid haemorrhage, intracerebral haemorrhage; head trauma; cerebral tumour; spinal trauma

Inclusion: mechanically ventilated adults between 18 and 80 years; not already intubated or transferred from other ICU; mechanically ventilated >12 hours; no continuous sedation infusion; not on controlled mechanical ventilation; ability to trigger the ventilator; no tracheostomy; no surgery scheduled for 72 hours. Exclusion: lesion affecting upper airway; pre‐existing decision to limit life support

Interventions

ICU staff trained and piloted the protocol during a 3‐month run in period

Intervention: daily readiness to wean criteria (GCS =/> 8; cough present; tracheal suctioning =/< 2/hour; normal sodium blood values; Temperature < 38.5oC; pH ≥ 7.35 and PaCO2 ≤ 50 mmHg; PaO2/FiO2 ratio ≥ 200 with PEEP ≤ 5 cmH2O; FiO2 ≤ 0.4; Heart rate ≤ 125 b/min; SBP ≥ 90 mmHg without vasoactive medication); followed by a 1‐hour SBT through ventilator circuit with 2 ‐ 3 cmH2O CPAP and FiO2 0.4. Extubation criteria: respiratory rate/tidal volume ratio ≤105, PaO2/FiO2 ≥200, pH ≥7.35 and PaCO2 ≤ 50 mmHg

Control: usual care that was daily evaluation by attending physician, weaning and extubation using their own clinical judgement

Outcomes

1. Rate of extubation within 48 hours (primary)

2. Duration of mechanical ventilation (days)

3. Length of ICU stay (mean/SD)

4. Length of hospital stay (mean/SD)

5. ICU Mortality N(%)

6. Rate of tracheostomy N(%)

Notes

Trial protocol was registered. ITT analysis performed. A priori power analysis showed that a recruitment of 280 patients (140 each group) over a 21 month period would detect a decrease in reintubation rate from 15% to 5% with 80% power at 5% two‐sided level of significance. Ethics committee approval; requirement for informed consent waived

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"A computer‐generated randomisation sequence was drawn up. We used a simple randomisation without blocks"

Allocation concealment (selection bias)

Low risk

"We utilised the same PC used to register the patient in the ICU, which was located in the office of the chief nurse. As soon as the patient was eligible, a person (the chief nurse from Monday to Friday) not involved in the study (i.e. not one of the authors) communicated to the attending physician the group of assignment"

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

Participants, staff and research personnel unblinded to the intervention, "however the analysis of data were performed by two investigators not involved either in the clinical management of patients and in data acquisition and report"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition and exclusions reported

Selective reporting (reporting bias)

Low risk

All a priori outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias. Sample size calculation stated (based on 80% power, α 0.05, 140 patients in each group)

Ogica 2007

Methods

Randomized controlled trial

Participants

Setting: Bucharest, Romania. Centre for bone marrow, liver and renal transplant (web site information), ICU and staffing not reported

Participants: 103 participants (51 intervention group, 52 control group)

Conditions: Surgical (abdominal) and myasthenia gravis

Inclusion: Not reported

Exclusion: Not reported

Interventions

Intervention: Readiness to wean criteria and SBT (communication)

Control: Not reported (classical ventilator disconnection)

Outcomes

1. Duration of MV

2. ICU length of stay

3. Reintubation

4. Mortality

Notes

Protocol registration not reported. The study was reported in a conference abstract and details on ITT, sample size calculation, ethics and trials methods are not reported. We were unable to contact the primary author for details, but managed to contact a co‐author who sent a data file, but could not elaborate further on study details.

Data entered into the meta‐analyses were calculated from the raw data sent by a co‐author

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not reported

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Not reported

Selective reporting (reporting bias)

Low risk

No study protocol, but usual outcomes reported

Other bias

Unclear risk

Abstract lacks detail to confirm

Piotto 2011

Methods

Quasi‐randomized controlled trial

Participants

Setting: Brazil, hospital not described. One coronary care unit. Staffing ratios not stated

Participants: 36 coronary care patients (intervention 18, control 18)

Conditions: myocardial revascularization; valve surgery; acute coronary syndrome; CHF; pulmonary thromboembolism

Inclusion: mechanically ventilated > 24 hours. Exclusion: conditions that might result in difficulty understanding informed consent; lack of consent; end‐stage diseases; dependence on MV

Interventions

Predetermined protocol entry criteria specified. After resolution of cause for MV resolved, all patients underwent a daily clinical evaluation according to prespecified criteria

Intervention: SBT 120 minutes delivered by RT then extubation

Control: weaning according to physician and RT judgement, typically gradual reduction in ventilatory support (RR and PS) and in some cases SBT without evaluation of clinical criteria

Outcomes

1. Reintubation rate during hospitalization (primary)

2. Length of CCU stay

3. Time from intubation to start of weaning

4. Time from start of weaning to extubation

5. Time from SBT to extubation

6. Presence of respiratory infection in patients requiring reintubation

7. Mortality of patients requiring reintubation

Notes

Protocol registration not reported. Sample size calculation based on 80% power to detect a difference in reintubation rate of 15% in the intervention group and 60% in the control group, 17 patients per group. Informed consent required: ethical approval obtained

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

1st recruited patient into experimental group, 2nd into control group, thereafter alternated

Allocation concealment (selection bias)

High risk

Not concealed

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Recruitment and attrition data not reported

Selective reporting (reporting bias)

Low risk

Study protocol is available; all prespecified outcomes reported

Other bias

Low risk

Sample size calculation based on 80% power to detect a difference in reintubation of 15% in experimental group and 60% in control group, α 0.05, 17 patients in each group. Ethics Committee approval obtained

Reardon 2011

Methods

Randomized controlled trial

Participants

Setting: US; single, academic, urban, tertiary medical centre with closed medical ICU

Participants: 33 adult participants (15 intervention group; 18 control group)

Conditions: Respiratory insufficiency

Inclusion:18 years and older; mechanically ventilated via endotracheal tube; requiring mechanical ventilation for > 48 hours

Exclusion: do not resuscitate status; tracheostomy; cardiac arrest > 5 minutes with poor neurological prognosis; pregnancy; transfer from another institution; baseline PaCO2 > 60 mmHg

Interventions

Intervention: computer‐driven weaning program ‐ Drager Evita Smartcare System

Control: usual care weaning that was SBT or PS (10 cmH2O or less with PEEP 5 cmH2O) for 30‐120 minutes

Outcomes

1. Duration of weaning (primary)

2. Duration of ICU stay

3. Duration of mechanical ventilation

4. Duration of hospitalization

5. Mortality

6. Sedation requirements

7. No. of SBTs prior to extubation

8. Complications (mortality during weaning; VAP; self extubation; reintubation rate)

Notes

Study was not published. Information obtained from the trial registration site. Trial started January 2007 and stopped May 2010 prior to reaching recruitment target because of slow recruitment and inadequate resources. ITT analyses. Sample size calculation based on 80% power to detect a difference in weaning time of 1.5 (SD 4) days, α 0.05, 220 patients. Protocol approved by Boston University Institutional Review Board

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"Randomization was performed utilizing an online random number generator with permuted blocks of four, stratified by etiology of respiratory failure ..."

Allocation concealment (selection bias)

Low risk

"...and revealed through opening of opaque envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Unclear from the trial register

Selective reporting (reporting bias)

Unclear risk

Some outcomes not reported: total duration of MV; ICU length of stay

Other bias

Unclear risk

Trial started January 2007 and stopped May 2010 prior to reaching recruitment target because of slow recruitment and inadequate resources

Roh 2012

Methods

Randomized controlled trial

Participants

Setting: Asan Medical Center, a tertiary academic hospital with 2680 beds in Seoul, Korea. Medical ICU, a closed ICU with 28 beds staffed by 3 attending physicians; 2 ICU fellows; and 6 medical residents in their 2nd or 3rd years. Physicians work in 3 teams each with 3/4 physicians. All physicians attend structured twice daily bedside rounds lastly approximately 2 hours. Decisions about management of mechanically ventilated patients are based on electronic templates and medical records that cover each major physiologic system and completed daily by house staff and charge nurses. Most physicians remain in the ICU for their entire working hours, and 2 house officers stay overnight. All nurses are registered nurses, and the nurse‐to patient ratio was 1:2.5, plus 4 additional senior nurses. Two respiratory therapists were involved in the management of mechanically ventilated patients

Participants: 122 enrolled (61 intervention group, 61 control group)

Conditions: acute exacerbation of COPD; postoperative; pulmonary oedema; pneumonia; sepsis

Inclusion: PaO2/FIO2 > 200 mm Hg; minute ventilation <15 L/min; age 18 to 90 years; pH > 7.3; serum potassium 3 to 5 mmol/L; serum sodium 128 to 150 mmol/L; Hemoglobin > 7 g/dL

Exclusion: do‐not‐resuscitate order; ventilatory support less than 12 hours or greater than 14 days; on non‐invasive ventilation; active bleeding; known or suspected increased intracranial pressure

Interventions

Intervention: Nurse‐directed protocol with an algorithm outlining steps that included stepwise reductions in FiO2 to >/= 0.4 and PEEP to </= 5 cmH2O; followed by screening for readiness to wean and CPAP trial at 5 cmH2O for 5 minutes; then gradual PS weaning to 5 cmH2O; followed by SBT via T‐piece for 30 minutes. If successful, screen for extubation and if ready notify physician

Control: Weaning at the discretion of the medical resident physicians (blinded to the weaning protocol used in the intervention group)

Outcomes

1. Weaning time (primary) ‐ defined as the time from enrolment and randomization, to successful discontinuation of mechanical ventilation Classified as successfully weaned if able to breathe unassisted for 48 hours at their first spontaneous breathing trial

2. Overall duration of mechanical ventilation

3. Duration of stay in the ICU

4. Duration of hospitalization

5. Frequency of complications (tracheostomy, failure of discontinuation, death)

Notes

Protocol registration not reported. ITT analysis performed. Sample size calculation was based on the difference in weaning times in pilot study, sample size had 80% power to detect a significant effect, assuming 2‐sided type I error of 0.05 and the rate of the failure of discontinuation was 30%. Institutional review board of hospital approved the study protocol. Data entered into the meta‐analyses were calculated from the raw data sent by the authors

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A computerized randomization scheme was used

Allocation concealment (selection bias)

Low risk

A computerized randomization scheme used for group assignment at enrolment, and each assignment was indicated on a data form that was folded and sealed in an opaque envelope. The envelope was opened only after written informed consent, mostly provided by relatives because the patients were sedated. The charge nurse screened mechanically ventilated patients in the medical ICU every morning, and eligible patients were randomly assigned to the intervention or control group

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

122 enrolled, but duration of weaning and mechanical ventilation only reported for 93. Attrition not reported

Selective reporting (reporting bias)

Unclear risk

No registered protocol; reintubation is a common outcome, but not reported

Other bias

Low risk

None apparent

Rose 2008

Methods

Randomized controlled trial

Participants

Setting: Australia, 390 bed acute tertiary referral hospital with 100,000 admissions/annum. 24‐bed mixed medical/surgical/trauma ICU. Nurse to patient ratio 1:1, 9 intensivists providing twice‐daily structured rounds and supported by 26 hospital medical officers providing 24‐hour care.

Participants: 102 adult patients (51 intervention group; 51 control group)

Conditions: trauma; coma; postoperative; pneumonia; sepsis; heart failure

Inclusion: 24‐hour mandatory ventilation; a ventilator with SmartCare/PS software ready for use; PEEP ≤ 8 cmH2O; PaO2/FiO2 ratio >150 or SaO2 ≥ 90% with FiO2 0.5; Plateau Pressure ≤ 30 cmH2O; haemodynamic stability; temperature 36‐39 C; GCS > 4; no anticipated requirement for transport or surgery; successful completion of 30‐min SBT using max 20 cmH20 PS to achieve VT > 200mL

Exclusion: ventilator with software unavailable; CNS disorder with anticipated poor outcome

Interventions

Intervention: automated computerized protocol delivered by Draeger EvitaXL ventilator with SmartCareTM/PS software version 1.1. Programme monitors patient's respiratory status every 2 to 5 minutes and adjusts PS accordingly. When PS reduced to 7 cmH2O (or 5 cmH2O for tracheostomy), PEEP was reduced to 5 cmH2O and following a 1‐hour monitoring period patient assigned as having ventilator "separation potential"

Control: weaning of PS and PEEP according to usual local practice in the absence of formal guidelines. When PS reduced to 7 cmH2O (or 5 cmH2O for tracheostomy), PEEP was reduced to 5 cmH2O and following a 1‐hour monitoring period patient assigned as having ventilator "separation potential"

Outcomes

1. Time to separation (immediately following successful 30‐minute PS SBT [randomization] to declaring "separation potential") in hours

2. Total duration of weaning (randomization to successful extubation)

3. Time from intubation to first extubation

4. Time from intubation to successful extubation

5. Length of ICU stay

6. Length of hospital stay

7. ICU Mortality

8. Rate of successful extubation

9. Rate of reintubation

10. Rate of use of non‐invasive ventilation postextubation

11. Tracheostomy

12. Prolonged mechanical ventilation > 14 days

Notes

Protocol registration not reported. ITT analysis. Sample size calculation not reported. Ethical approval. Required written informed consent from next‐of‐kin and later patients (when competent)

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated block randomization (block size 4)

Allocation concealment (selection bias)

Low risk

Administered through a sequential opaque envelope technique

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Attrition and exclusions reported

Selective reporting (reporting bias)

Low risk

All a priori outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias

Simeone 2002

Methods

Randomized controlled trial

Participants

Setting: Italy, hospital not described. One cardiac surgical ICU. Staffing ratios not stated

Participants: 49 patients > 15 years of age (intervention 24, control 25)

Conditions: elective coronary, aortic and mitral valve surgery

Inclusion: low or medium Higgins risk score

Exclusion: FiO2 > 0.5%; PEEP > 10 cmH2O to achieve O2 sat > 90%; PEEP > 10 cmH2O; excessive respiratory secretions; uncontrolled arrhythmias; high inotropic support; bleeding > 250 mLs in first hour; contraindications to steroid administration

Interventions

Intervention: protocol consisting of reduction in SIMV and 2 cmH2O stepwise reduction in PSV until SIMV 0 and PS 4 cmH2O, then extubation

Control: weaning according to physician's subjective clinical judgement without the aid of the measured indexes

Outcomes

1. Total duration of mechanical ventilation (intubation time)

2. ICU length of stay

3. Number of complications recorded (cardiac tamponade; myocardial ischaemia; increased creatinine level; aphasia; disorientation; paralysis; postoperative bleeding; reintubation due to epileptic crisis)

Notes

Protocol registration not reported. ITT not reported. Sample size calculation not reported. Patients assessed 3rd/4th hour after admission. Predetermined protocol entry criteria specified. Ethical committee approval gained and informed consent required

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Used a random numbers table generated by a software program on a PC

Allocation concealment (selection bias)

Low risk

Each random number was associated with either 'control' or 'experimental' & was inserted into a black sealed envelope

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"The fellows were involved in collecting the data, not in weaning the patient" ‐ communication

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Outcomes were not prespecified. Recruitment and attrition data absent. ITT not stated

Selective reporting (reporting bias)

Unclear risk

Outcomes were not prespecified

Other bias

Unclear risk

No data to support following statements;

"...Patients that underwent a longer cardiopulmonary bypass time required prolonged MV support...". (Baseline showed patients in the control group had longer cardiopulmonary bypass times.)

"...a weaning protocol allows early identification of patients ready for spontaneous breathing, thus reducing MV dependence." (This outcome ‐ early identification or MV time prior to weaning ‐ was not measured.)

Data produced from a Fast Track Recovery study for comparison with weaning group data, but no information provided on this group of patients (nos., characteristics etc).

Sample size calculation not stated

Stahl 2009

Methods

Randomized controlled trial

Participants

Setting: University Hospital in Germany. Surgical ICU. Staffing ratios not stated

Participants: 60 patients, (intervention 30, control 30)

Conditions: abdominal, vascular, thoracic & trauma/orthopaedic surgery

Inclusion: 18‐80 years, mechanically ventilated via endotracheal tube or tracheostomy for at least 24 hours; breathing spontaneously; Ramsay sedation score ≤ 3; paO2 > 75 cmH2O or SaO2 > 90% at FiO2 ≤ 0.5; 18‐80 years; body weight 35 kg‐200 kg

Exclusion: PEEP > 10 cmH2O; haemodynamic instability with demand for catecholamines; rectal temperature > 39oC; haemoglobin < 7 g/dl; pH > 7.2

Interventions

Intervention: computerized automated weaning of CPAP/ASB mode (SmartCare TM/PS)

Control: physician‐directed weaning using no strict protocol, but PSV should be gradually reduced in single steps of no more than 15 cmH2O

Extubation criteria: respiratory rate, 30/minute; paO2 >75 cmH2O or SaO2 > 90%; sufficient airway protection; haemodynamic stability

Outcomes

1. Duration of ventilator weaning in days (time from switching controlled to assisted breathing (CPAP/ASB mode) until extubation or disconnection (if tracheostomy))

2. Total duration of MV until successful extubation

3. ICU length of stay

4. Reintubation within 48 hours

5. Physician workload (quantity of PSV, FiO2 and PEEP settings/hour)

6. Nursing workload (frequency of alarm "clean CO2 cuvette"/hour)

7. ICU and hospital mortality

Notes

Protocol registration not reported. ITT analysis. Sample size calculation based on 80% power to detect a difference of 2 days in weaning time, α 0.05, 54 patients each group. Local ethics committee approval; signed informed consent from patients or relatives

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomization list generated using RITA version 1.13a. Stratified randomization with age and duration of MV prior to weaning

Allocation concealment (selection bias)

Low risk

Opaque sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Participants, staff and research personnel were unblinded to the intervention

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

On contact, authors stated that "outcome assessors were independent from those managing patient care"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All a priori outcomes reported. ITT analysis performed

Selective reporting (reporting bias)

Low risk

Appears to be free of other sources of bias

Other bias

Unclear risk

Sample size calculation stated (based on 80% power to detect a difference of 2 days in weaning time, α 0.05, 54 patients each group). Unplanned interim analysis was undertaken because of low recruitment after 1 year: sample size and significance levels were recalculated (N = 60 patients) and after the 60th patient the trial was stopped for futility

Strickland 1993

Methods

Randomized controlled trial

Participants

Setting: USA, Medical ICU. Hospital description and staffing ratios not stated

Participants: 15 adult patients (intervention 9, control 6)

Conditions: COPD/asthma; septic shock; ARDS; pulmonary oedema

Inclusion: mechanically ventilated; judged ready to wean by physicians and meeting prespecified inclusion criteria

Exclusion: postoperative patients < 3 days

Interventions

Intervention: protocol delivered by a computer‐controlled weaning system (Supersport model 2, Zenith Data Systems) consisting of stepwise reductions in SIMV and PSV responsive to tidal volume & respiratory rate sampling (computer‐directed algorithm)

Control: weaning with SIMV and PS reduction as judged appropriate by the patient's physician

Outcomes

1. Time spent with RR < 8 or > 30

2. Time spent with tidal volume < 5 mL/kg

3. No. of arterial blood gases drawn during weaning

4. Weaning duration

5. MV prior to weaning

Notes

Protocol registration not reported. ITT performed. No sample size calculation performed. Study period and data collection were limited to 48 hours because only one computer system was available for the study. Study approved by hospital Institutional Review Board and informed consent required

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Impossible to blind personnel to the intervention groups

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Outcome assessors were independent from the individuals administering/supervising the intervention

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data. Recruitment and attrition data presented

Selective reporting (reporting bias)

Low risk

All prespecified outcomes reported

Other bias

Low risk

Appears to be free of other sources of bias. No sample size calculation stated

ARDS ‐ acute respiratory distress syndrome; ASB ‐ assisted spontaneous breathing; CPAP ‐ continuous positive airway pressure; CHF ‐ congestive heart failure; COPD ‐ chronic obstructive pulmonary disease; GI ‐ gastrointestinal; ICU ‐ intensive care unit; IMV ‐ intermittent mandatory ventilation; ITT ‐ intention to treat; MD ‐ medical doctor; MSOF ‐ multi‐system organ failure; MV ‐ mechanical ventilation; NIV = non‐invasive ventilation; PC ‐ personal computer; PEEP ‐ positive end expiratory pressure; PS ‐ pressure support; PSV ‐ pressure support ventilation; RN ‐ registered nurse; RR ‐ respiratory rate; RT ‐ respiratory therapist; SBT‐ spontaneous breathing trial; SD ‐standard deviation; VAP ‐ ventilator‐associated pneumonia.

 

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Beale 2008

Compared an automated protocol with protocol guided weaning. The comparator did not fulfil our inclusion criteria

Donglemans 2009

Intervention group was weaned using a computer protocol and compared with a control group where weaning was undertaken using standardized guidelines. Control group did not meet the review inclusion criteria (i.e. was not 'non‐protocolized' according to our definition)

East 1999

The authors evaluated automated (computerized) protocolized weaning in a population of acute respiratory distress syndrome patients using a cluster randomized controlled trial. From the papers, we were unable to identify the comparator or the weaning outcomes and we were unable to contact the authors to obtain further information

Gnanapandithan 2011

Compared two weaning protocols involving gradual pressure support reduction with or without a spontaneous breathing trial. The comparator did not fulfil our inclusion criteria

Lellouche 2006

Intervention group was weaned using a computer protocol and compared with a control group where weaning was undertaken using standardized guidelines. Control group did not meet the review inclusion criteria (i.e. was not 'non‐protocolized' according to our definition)

Liu 2013

Compared computer‐driven automated weaning system with a local protocol based on local written weaning guidelines

Ma 2010a

Compared the use of a spontaneous breathing trial (SBT) prior to extubation versus no SBT prior to extubation when both groups met weaning readiness criteria. The intervention does not fulfil the definition of a weaning protocol

Ma 2010b

Compared an automated protocol with a standard weaning protocol. The comparator did not fulfil our inclusion criteria

McKinley 2001

The authors evaluated automated (computerized) protocolized weaning in a population of acute respiratory distress syndrome patients using a cluster randomized controlled trial. From the papers, we were unable to identify the comparator or the weaning outcomes and we were unable to contact the authors to obtain further information

NCT00157287

This was a cluster randomized controlled trial comparing an evidence based protocol with standard practice (no guidelines). The study was stopped due to recruitment problems and we were unable to obtain sufficient data to include it in the review

NCT00445289

Compared an automated protocol with a standard weaning protocol. The comparator did not fulfil our inclusion criteria

NCT00502489

Control group weaning is not 'non‐protocolized' according to our definition

Taniguchi 2009

Intervention group was weaned using a computer protocol and compared with a control group where weaning was undertaken using standardized guidelines. Control group did not meet the review inclusion criteria (i.e. was not 'non‐protocolized' according to our definition)

Vaschetto 2011

Types of participants were tracheotomized patients only. Did not meet our study inclusion criteria

Data and analyses

Open in table viewer
Comparison 1. Primary analysis: protocolized versus non‐protocolized weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV by type of unit Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

Analysis 1.1

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 1 Total duration of MV by type of unit.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 1 Total duration of MV by type of unit.

1.1 Mixed ICUs

6

940

Mean Difference (IV, Random, 95% CI)

‐0.23 [‐0.44, ‐0.02]

1.2 Neuro ICUs

2

418

Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.20, 0.18]

1.3 Surgical ICUs

3

201

Mean Difference (IV, Random, 95% CI)

‐0.63 [‐1.05, ‐0.22]

1.4 Medical ICUs

3

646

Mean Difference (IV, Random, 95% CI)

‐0.34 [‐0.61, ‐0.07]

2 Total duration of MV by type of approach Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

Analysis 1.2

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 2 Total duration of MV by type of approach.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 2 Total duration of MV by type of approach.

2.1 professional‐led

12

2051

Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.40, ‐0.13]

2.2 computer‐driven

2

154

Mean Difference (IV, Random, 95% CI)

‐0.50 [‐1.42, 0.42]

3 Total duration of MV by type of protocol [log hours] Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

Analysis 1.3

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 3 Total duration of MV by type of protocol [log hours].

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 3 Total duration of MV by type of protocol [log hours].

3.1 SBT protocol

8

1188

Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.36, 0.00]

3.2 Stepwise reduction protocol

6

1017

Mean Difference (IV, Random, 95% CI)

‐0.42 [‐0.66, ‐0.18]

4 Mortality Show forest plot

14

2234

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.82, 1.26]

Analysis 1.4

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 4 Mortality.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 4 Mortality.

4.1 Hospital mortality

8

1523

Odds Ratio (M‐H, Fixed, 95% CI)

1.04 [0.82, 1.32]

4.2 ICU mortality

7

711

Odds Ratio (M‐H, Fixed, 95% CI)

0.93 [0.58, 1.48]

5 Reintubation Show forest plot

11

1487

Odds Ratio (M‐H, Random, 95% CI)

0.74 [0.44, 1.23]

Analysis 1.5

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 5 Reintubation.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 5 Reintubation.

6 Self extubation Show forest plot

3

433

Odds Ratio (M‐H, Random, 95% CI)

0.43 [0.14, 1.34]

Analysis 1.6

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 6 Self extubation.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 6 Self extubation.

7 Tracheostomy Show forest plot

8

1346

Odds Ratio (M‐H, Random, 95% CI)

0.85 [0.51, 1.40]

Analysis 1.7

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 7 Tracheostomy.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 7 Tracheostomy.

8 Weaning duration by type of ICU Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

Analysis 1.8

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 8 Weaning duration by type of ICU.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 8 Weaning duration by type of ICU.

8.1 Surgical ICUs

1

52

Mean Difference (IV, Random, 95% CI)

‐1.29 [‐2.42, ‐0.16]

8.2 Mixed ICUs

3

473

Mean Difference (IV, Random, 95% CI)

‐1.39 [‐3.17, 0.39]

8.3 Medical ICUs

4

464

Mean Difference (IV, Random, 95% CI)

‐1.02 [‐2.08, 0.03]

9 Weaning duration by type of approach Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

Analysis 1.9

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 9 Weaning duration by type of approach.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 9 Weaning duration by type of approach.

9.1 Professional‐led

4

793

Mean Difference (IV, Random, 95% CI)

‐1.90 [‐3.37, ‐0.43]

9.2 Computer‐driven

4

196

Mean Difference (IV, Random, 95% CI)

‐0.35 [‐0.69, ‐0.00]

10 Weaning duration by type of protocol [log hours] Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

Analysis 1.10

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 10 Weaning duration by type of protocol [log hours].

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 10 Weaning duration by type of protocol [log hours].

10.1 SBT protocol

2

336

Mean Difference (IV, Random, 95% CI)

‐3.23 [‐3.57, ‐2.89]

10.2 Stepwise reduction protocol

6

653

Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.81, ‐0.12]

11 ICU length of stay Show forest plot

9

1378

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.21, ‐0.03]

Analysis 1.11

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 11 ICU length of stay.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 11 ICU length of stay.

12 Hospital length of stay Show forest plot

5

977

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.11, 0.09]

Analysis 1.12

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 12 Hospital length of stay.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 12 Hospital length of stay.

13 ICU costs Show forest plot

2

400

Mean Difference (IV, Random, 95% CI)

3.37 [‐15.02, 21.76]

Analysis 1.13

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 13 ICU costs.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 13 ICU costs.

14 Hospital costs Show forest plot

3

757

Mean Difference (IV, Random, 95% CI)

‐0.59 [‐4.67, 3.49]

Analysis 1.14

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 14 Hospital costs.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 14 Hospital costs.

Open in table viewer
Comparison 2. Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV Show forest plot

12

1945

Mean Difference (IV, Random, 95% CI)

‐0.33 [‐0.50, ‐0.16]

Analysis 2.1

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 1 Total duration of MV.

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 1 Total duration of MV.

2 Weaning duration Show forest plot

5

499

Mean Difference (IV, Random, 95% CI)

‐1.64 [‐3.18, ‐0.10]

Analysis 2.2

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 2 Weaning duration.

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 2 Weaning duration.

Open in table viewer
Comparison 3. Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐20.26 [‐35.28, ‐5.24]

Analysis 3.1

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 1 Total duration of MV.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 1 Total duration of MV.

2 Weaning duration Show forest plot

7

739

Mean Difference (IV, Random, 95% CI)

‐39.35 [‐67.38, ‐11.32]

Analysis 3.2

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 2 Weaning duration.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 2 Weaning duration.

3 ICU length of stay Show forest plot

9

1378

Mean Difference (IV, Fixed, 95% CI)

‐9.08 [‐15.85, ‐2.30]

Analysis 3.3

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 3 ICU length of stay.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 3 ICU length of stay.

4 Hospital length of stay Show forest plot

5

977

Mean Difference (IV, Fixed, 95% CI)

‐1.32 [‐3.09, 0.44]

Analysis 3.4

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 4 Hospital length of stay.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 4 Hospital length of stay.

Updated study flow diagram.
Figures and Tables -
Figure 1

Updated study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
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.
Figures and Tables -
Figure 3

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

Forest plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.3 Total duration of mechanical ventilation by type of protocol [log hours].
Figures and Tables -
Figure 4

Forest plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.3 Total duration of mechanical ventilation by type of protocol [log hours].

Forest plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.9 Weaning duration by type of approach [log hours].
Figures and Tables -
Figure 5

Forest plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.9 Weaning duration by type of approach [log hours].

Funnel plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.2 Total duration of MV by type of approach [log hours].
Figures and Tables -
Figure 6

Funnel plot of comparison: 1 Primary analysis: protocolized versus non‐protocolized weaning, outcome: 1.2 Total duration of MV by type of approach [log hours].

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 1 Total duration of MV by type of unit.
Figures and Tables -
Analysis 1.1

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 1 Total duration of MV by type of unit.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 2 Total duration of MV by type of approach.
Figures and Tables -
Analysis 1.2

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 2 Total duration of MV by type of approach.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 3 Total duration of MV by type of protocol [log hours].
Figures and Tables -
Analysis 1.3

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 3 Total duration of MV by type of protocol [log hours].

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 4 Mortality.
Figures and Tables -
Analysis 1.4

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 4 Mortality.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 5 Reintubation.
Figures and Tables -
Analysis 1.5

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 5 Reintubation.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 6 Self extubation.
Figures and Tables -
Analysis 1.6

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 6 Self extubation.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 7 Tracheostomy.
Figures and Tables -
Analysis 1.7

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 7 Tracheostomy.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 8 Weaning duration by type of ICU.
Figures and Tables -
Analysis 1.8

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 8 Weaning duration by type of ICU.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 9 Weaning duration by type of approach.
Figures and Tables -
Analysis 1.9

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 9 Weaning duration by type of approach.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 10 Weaning duration by type of protocol [log hours].
Figures and Tables -
Analysis 1.10

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 10 Weaning duration by type of protocol [log hours].

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 11 ICU length of stay.
Figures and Tables -
Analysis 1.11

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 11 ICU length of stay.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 12 Hospital length of stay.
Figures and Tables -
Analysis 1.12

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 12 Hospital length of stay.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 13 ICU costs.
Figures and Tables -
Analysis 1.13

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 13 ICU costs.

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 14 Hospital costs.
Figures and Tables -
Analysis 1.14

Comparison 1 Primary analysis: protocolized versus non‐protocolized weaning, Outcome 14 Hospital costs.

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 1 Total duration of MV.
Figures and Tables -
Analysis 2.1

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 1 Total duration of MV.

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 2 Weaning duration.
Figures and Tables -
Analysis 2.2

Comparison 2 Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies, Outcome 2 Weaning duration.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 1 Total duration of MV.
Figures and Tables -
Analysis 3.1

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 1 Total duration of MV.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 2 Weaning duration.
Figures and Tables -
Analysis 3.2

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 2 Weaning duration.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 3 ICU length of stay.
Figures and Tables -
Analysis 3.3

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 3 ICU length of stay.

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 4 Hospital length of stay.
Figures and Tables -
Analysis 3.4

Comparison 3 Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data, Outcome 4 Hospital length of stay.

Protocolized versus non‐protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients

Patient or population: mechanically ventilated adult patients

Settings: intensive care units

Intervention: protocolized weaning

Comparison: non‐protocolized weaning

Outcomes

Illustrative comparative risks* (95% CI)

Effect Estimates

(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

non‐protocolized weaning

Corresponding risk

protocolized weaning

Total duration of mechanical ventilation

(hours)

Mean 96 hours1

Mean 71 hours (60.5 to 83.5 hours)

Geometric mean difference

‐26% (‐37% to ‐13%)

2205
[14 studies]

+++O
moderate2

Weaning duration

(hours)

Mean 24 hours1

Mean 7 hours (2.8 to 17.5 hours)

Geometric mean difference

‐70% (‐88% to ‐27%)

989
[8 studies]

++OO
low3

ICU length of stay (days)

Mean 8 days1

Mean 7 days (6.5 to 7.8 days)

Geometric mean difference

‐11% (‐19% to ‐3%)

1378

[9 studies]

++OO
low4

ICU mortality

31%1

30% (20% to 42%)

OR 0.97 (0.57 to 1.63)

651

[6 studies]

+++O
moderate5

Reintubation

10%1

(following deliberate extubation)

8% (5% to 12%)

OR 0.74 (0.44 to 1.23)

1487

[11 studies]

++OO
moderate6

*The basis for the assumed risk (e.g. the mean control group risk) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the effect estimate of the intervention (and its 95% CI).

CI: Confidence interval; ICU: intensive care unit; OR: Odds 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 (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality (++OO): 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 (+OOO): We are very uncertain about the estimate.

1 The assumed risk is derived from the median reported in a large epidemiological study of characteristics and outcomes in patients (N = 4968) receiving mechanical ventilation by Esteban 2008. The reported medians were used as an approximation for the means used for illustrative comparisons of all continuous variables. The table shows the mean duration of mechanical ventilation, weaning and ICU length of stay if patients are not weaning by protocol (non‐protocolized weaning) and what would be expected with protocolized weaning based on the effect estimates from our review.

2 There was considerable variability in effect estimates (I2 = 67%) that could not be explained by subgroup analysis although variability was lower than the previous review. The confidence interval was narrower in this review and the difference at the lower limit would still be clinically significant.

3 There was considerable variability in effect estimates (I2 = 97%) and the wide confidence intervals indicate imprecision in results. The lower limit suggests a one hour difference in weaning that is not clinically significant.

4 There was no heterogeneity among trials effects estimates, but wide confidence intervals indicate imprecision in results.

5 There was moderate variability in effect estimates (I2 = 50%).

6 There was moderate variability in effect estimates (I2 = 43%).

Figures and Tables -
Table 1. Readiness to wean criteria

Study

Assessment frequency

Oxygenation

Other respiratory factors 

Cardiovascular

Neurological

Inflammatory response

Medication

Other 

Chaiwat 2010

Daily screen

PaO2/FiO2 >/= 200 on FiO2 </= 0.4

SpO2 >/= 94%

PEEP </= 5

Respiratory rate < 35

Rapid Shallow breathing index

</= 105

Static lung compliance >/= 25 mL/cmH2O

Minute volume </= 10L/min

HR < 120 b/min

Awake and easily rousable

Not included

Dopamine </= 5 ug/kg/min

Noradrenaline </= 5 ug/kg/min

Pain score < 4

de Carvalho Oliveira 2002

Not reported

PaO2 < 90 on FiO2 </= 0.4

PEEP < 5

Pimax < ‐ 25 cm H2O

Not included

GCS > 8

Not included

No sedation

No vasopressors

Cause of MV resolved

No planned surgery

Ely 1996

Daily screen

 

PaO2/FiO2 > 200

PEEP </= 5

f/VT </= 105

 Not included

 Not included

 Not included

No vasopressors or sedation

Adequate cough

 

Fan 2013

Daily screen

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Kollef 1997

Protocol entry criteria

 

PaO2/FiO2 > 200

PEEP </= 5

RR </= 35 b/min

 

HR < 140 b/min

Awake and orientated

 Not included

No vasoactive or inotropic agents

 Not included

Krishnan 2004

Daily screen

 

SpO2 >/= 92%

FiO2 </= 0.5

PEEP </=5

 

Stable CAD

HR < 140 b/min

No raised ICP

 Not included

No paralytics

Cough and gag reflex present

Responsive to stimuli

 

Marelich 2000

x 2 daily screen

 

PaO2/FiO2 >/= 200

 Not included

MAP >/= 60 mmHg

GCS >/= 10 or tracheostomy

 Not included

No vasopressors

Dopamine </= 5 ug/kg/min

Adequate cough not limited by pain

 

Namen 2001

Daily screen

PaO2/FiO2 > 200

PEEP </= 5

f/VT </= 105

 Not included

 Not included

 Not included

No vasopressors or sedation

Adequate cough

 

Navalesi 2008

Daily screen

PaO2/FiO2 > 200

FiO2 </= 0.4

pH >/= 7.35

PaCO2 </= 50 mmHg

PEEP </= 5

 

HR </= 125 b/min

SBP >/= 90 mmHg

GCS >/= 8

T < 38.5oC

No vasopressors

Dopamine </= 5 ug/kg/min

Adequate cough

Suctioning < 2/hr

Normal Na blood values

 

Ogica 2007

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Piotto 2011

Daily screen

PaO2/FiO2 150‐300

FiO2 </= 0.4

PaO2 >/= 60 mmHg

Hb = 8 ‐ 10 g/L

 

 Not included

MAP >/= 60 mmHg

HR </= 140 b/min

Awake

GCS >/= 9

T < 37.8oC

Minimum sedation

No or low vasopressors

Cause of MV resolved

Effective cough

Metabolic stability

No hydroelectrolyte disorders

 

Reardon 2011

Daily screen

SaO2 > 90% or PaO2 > 60 mmHg on FiO2 </= 0.5

Respiratory rate < 35

pH > 7.20

Triggering breaths

SBP > 90 and < 180

HR > 50 and < 130

No cardiac ischaemia

GCS > 8

Not included

Minimal pressure requirements

Improving condition

Absence of excessive secretions

Suctioning < hourly

Deemed ready to wean

Roh 2012

Not reported

FiO2 </= 0.5

RR </= 35

PEEP </= 8

Triggering breaths

SBP >/= 90 mmHg

HR </= 150 b/min

Not included

Not included

No paralytics

No vasopressors

Dopamine </= 5 ug/kg/min

Noradrenaline </= 5 ug/kg/min

Not included

Rose 2008

Inclusion criteria

PaO2/FiO2 > 150 or SaO2 >/= 90% on FiO2 0.5

PEEP </= 8

Plateau pressure </= 30 cmH2O

Successful 30 min SBT using PS 20 cm H2O

to achieve TV > 200 mL

 

Haemodynamically stable

GCS > 4

T = 36 ‐ 39oC

 Not included

No surgery anticipated

MV > 24 hr

 

Simeone 2002

Inclusion criteria

PaO2/FiO2 >/= 200

FiO2 < 0.5

pH 7.3 ‐ 7.5

PaO2 30 ‐ 50 mmHg

SaO2 > 90%

Hb > 8 mg/dL

Pulse oximeter oxygenation stable

Cardiopulmonary bypass time < 150 min

PEEP < 4

RR < 35 b/min

Dynamic compliance > 22 mL/cmH2O

Compliance statica >33 mL/cmH2O

Vital capacity >10 mL/kg

MIP >/= ‐15 cmH2O

 

Haemodynamically stable

Awake and conscious

T > 35 < 38oC

 Not included

Urine output > 100 mL/hr

Normal CXR

Stahl 2009

Inclusion criteria

FiO2 </= 0.5

PaO2 > 75 mmHg or SaO2 > 90%

pH </= 7.2

Hb >/= 7g/dL

PEEP </= 10

Haemodynamically stable

 Not included

 Not included

Dopamine </= 5 ug/kg/min

MV > 24 hr

Breathing spontaneously

Ramsey sedation score =/< 3

 

Strickland 1993

Inclusion criteria

FiO2 </= 0.4

pH >/= 7.3 </= 7.5

PCO2 >/= 30 </= 50

SaO2 >/= 90% on SIMV rate 6 ‐ 10

PS 20 cmH2O

NIF </= ‐ 20 cmH2O

FVC >/= 10 mL/kg

TV 10 ‐ 15 mL/kg

 

Haemodynamically stable

 Not included

T </= 37oC

 Not included

Judged ready to wean by physician

Feeding ‐  parenteral or tube

Stable renal function

Normal electrolytes

 

CAD = coronary artery diease; CXR = chest X‐ray; GCS = Glasgow Coma Scale; FVC = forced vital capacity; Hb = haemoglobin; HR ‐ heart rate; MAP = mean arterial pressure; MIP = maximal inspiratory pressure; MV = mechanical ventilation; NIF = negative inspiratory force; PEEP = positive end expiratory pressure; Pimax = maximal inspiratory mouth pressure; PS = pressure support; RR = respiratory rate; SBP = systolic blood pressure; SIMV = synchronized intermittent mechanical ventilation; T = temperature; TV = tidal volume; f/VT = ratio of respiratory frequency to tidal volume.

Figures and Tables -
Table 1. Readiness to wean criteria
Table 2. Weaning protocol differences

Study

Time of randomization

Intervention protocol

Extubation criteria 

Comparator (usual practice)

Chaiwat 2010

ICU admission

SBP on PS 7 cmH2O, PEEP 5 cmH2O for 2 hours

Notify MD

Not reported

de Carvalho Oliveira 2002

Not reported

SBP on PS 7 cmH2O, PEEP 5 cmH2O for 2 hours

Yes

Not reported

Ely 1996

Enrolment, time not reported

SBT 2 hour on CPAP 5 cmH2O

Notify MD

Not reported

Fan 2013

Not reported

a) SBT 30 minutes and extubation if passed

b) If failed, daily SBT and stepwise reduction in SIMV and PS until 4 breaths/min and PS 7 cmH2O

Not reported

Not reported

Kollef 1997

ICU admission 

a) SBT 30 to 60 min on CPAP 5 cmH2O, PS 6 cmH2O

b) PS stepwise reduction to 6 cmH2O

c) IMV stepwise reduction to 0 breaths/min, on  PEEP 5 cmH2O and PS 6 cmH2O for 30 to 60 min

a) Yes

 

b) Yes

c) Yes

Not reported

Krishnan 2004

Not reported

SBT 1 hour on CPAP 5 cmH2O

Notify MD

Not reported

Marelich 2000

On meeting weaning criteria

a) < 72‐hour admissions: SBT 30 min on PS </= 8 cmH2O & PEEP </= 8 cmH2O

b) > 72‐hour admissions: PEEP, IMV and PS stepwise reductions to achieve FiO2 0.5,

PEEP </= 8 cmH2O, IMV </= 6 breaths/min, PS </= 8 cmH2O then SBT as above

a) Notify MD

 

b) Notify MD

Not reported

Namen 2001

On meeting weaning criteria

SBT 2 hours on CPAP 5 cmH2O

Notify MD

Not reported

Navalesi 2008

Enrolment, time not reported

SBT 1 hour on CPAP 2 to 3 cmH2O, FiO2 0.4

Yes

Not reported

Ogica 2007

Not reported

SBT (details not reported)

Not reported

Not reported

Piotto 2011

Not reported

SBT 2 hours on PS 7 cmH2O, PEEP 5 cmH2O, FiO2 0.4, RR 1 breath/min

Yes

Stepwise reduction in PS and IMV

Reardon 2011

On meeting weaning criteria

Computer automated SmartCareTM/PS with stepwise reductions to PS 7 cmH2O and PEEP 5 cmH2O

Notify MD

Stepwise reduction in PS and SBT

Roh 2012

On meeting weaning criteria

CPAP trial on 5 cmH2O, then stepwise reductions in PS to 5 cmH2O,

then SBT on T‐piece for 30 minutes

Yes

Not reported

Rose 2008

On meeting weaning criteria

Computer automated SmartCareTM/PS with stepwise reductions to PS 7 cmH2O and PEEP 5 cmH2O

No

Stepwise reduction in PS and PEEP

Simeone 2002

Not reported

SIMV and PS stepwise reductions to SIMV 0 breath/min and PS 4 cmH2O

Yes

Not reported

Stahl 2009

On meeting weaning criteria 

Computer automated SmartCareTM/PS stepwise reductions to PS

Yes

Spepwise reduction in PS and CPAP

Strickland 1993

On meeting weaning criteria

Computer automated Supersport model 2

stepwise reductions in SIMV and PS to RR 2 breaths/min and PS 5 cmH2O

 Not reported

Stepwise reduction in IMV and PS

CPAP = continuous positive airway pressure; IMV = intermittent mechanical ventilation; MD = Medical Doctor; PEEP = positive end expiratory pressure; PS = pressure support; SBT = spontaneous breathing trial; SIMV =synchronized intermittent mechanical ventilation; RR = respiratory rate.

Figures and Tables -
Table 2. Weaning protocol differences
Comparison 1. Primary analysis: protocolized versus non‐protocolized weaning

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV by type of unit Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

1.1 Mixed ICUs

6

940

Mean Difference (IV, Random, 95% CI)

‐0.23 [‐0.44, ‐0.02]

1.2 Neuro ICUs

2

418

Mean Difference (IV, Random, 95% CI)

‐0.01 [‐0.20, 0.18]

1.3 Surgical ICUs

3

201

Mean Difference (IV, Random, 95% CI)

‐0.63 [‐1.05, ‐0.22]

1.4 Medical ICUs

3

646

Mean Difference (IV, Random, 95% CI)

‐0.34 [‐0.61, ‐0.07]

2 Total duration of MV by type of approach Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

2.1 professional‐led

12

2051

Mean Difference (IV, Random, 95% CI)

‐0.27 [‐0.40, ‐0.13]

2.2 computer‐driven

2

154

Mean Difference (IV, Random, 95% CI)

‐0.50 [‐1.42, 0.42]

3 Total duration of MV by type of protocol [log hours] Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐0.30 [‐0.46, ‐0.14]

3.1 SBT protocol

8

1188

Mean Difference (IV, Random, 95% CI)

‐0.18 [‐0.36, 0.00]

3.2 Stepwise reduction protocol

6

1017

Mean Difference (IV, Random, 95% CI)

‐0.42 [‐0.66, ‐0.18]

4 Mortality Show forest plot

14

2234

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.82, 1.26]

4.1 Hospital mortality

8

1523

Odds Ratio (M‐H, Fixed, 95% CI)

1.04 [0.82, 1.32]

4.2 ICU mortality

7

711

Odds Ratio (M‐H, Fixed, 95% CI)

0.93 [0.58, 1.48]

5 Reintubation Show forest plot

11

1487

Odds Ratio (M‐H, Random, 95% CI)

0.74 [0.44, 1.23]

6 Self extubation Show forest plot

3

433

Odds Ratio (M‐H, Random, 95% CI)

0.43 [0.14, 1.34]

7 Tracheostomy Show forest plot

8

1346

Odds Ratio (M‐H, Random, 95% CI)

0.85 [0.51, 1.40]

8 Weaning duration by type of ICU Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

8.1 Surgical ICUs

1

52

Mean Difference (IV, Random, 95% CI)

‐1.29 [‐2.42, ‐0.16]

8.2 Mixed ICUs

3

473

Mean Difference (IV, Random, 95% CI)

‐1.39 [‐3.17, 0.39]

8.3 Medical ICUs

4

464

Mean Difference (IV, Random, 95% CI)

‐1.02 [‐2.08, 0.03]

9 Weaning duration by type of approach Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

9.1 Professional‐led

4

793

Mean Difference (IV, Random, 95% CI)

‐1.90 [‐3.37, ‐0.43]

9.2 Computer‐driven

4

196

Mean Difference (IV, Random, 95% CI)

‐0.35 [‐0.69, ‐0.00]

10 Weaning duration by type of protocol [log hours] Show forest plot

8

989

Mean Difference (IV, Random, 95% CI)

‐1.20 [‐2.10, ‐0.31]

10.1 SBT protocol

2

336

Mean Difference (IV, Random, 95% CI)

‐3.23 [‐3.57, ‐2.89]

10.2 Stepwise reduction protocol

6

653

Mean Difference (IV, Random, 95% CI)

‐0.46 [‐0.81, ‐0.12]

11 ICU length of stay Show forest plot

9

1378

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.21, ‐0.03]

12 Hospital length of stay Show forest plot

5

977

Mean Difference (IV, Fixed, 95% CI)

‐0.01 [‐0.11, 0.09]

13 ICU costs Show forest plot

2

400

Mean Difference (IV, Random, 95% CI)

3.37 [‐15.02, 21.76]

14 Hospital costs Show forest plot

3

757

Mean Difference (IV, Random, 95% CI)

‐0.59 [‐4.67, 3.49]

Figures and Tables -
Comparison 1. Primary analysis: protocolized versus non‐protocolized weaning
Comparison 2. Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV Show forest plot

12

1945

Mean Difference (IV, Random, 95% CI)

‐0.33 [‐0.50, ‐0.16]

2 Weaning duration Show forest plot

5

499

Mean Difference (IV, Random, 95% CI)

‐1.64 [‐3.18, ‐0.10]

Figures and Tables -
Comparison 2. Sensitivity analysis: protocolized versus non‐protocolized weaning excluding high risk of bias studies
Comparison 3. Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Total duration of MV Show forest plot

14

2205

Mean Difference (IV, Random, 95% CI)

‐20.26 [‐35.28, ‐5.24]

2 Weaning duration Show forest plot

7

739

Mean Difference (IV, Random, 95% CI)

‐39.35 [‐67.38, ‐11.32]

3 ICU length of stay Show forest plot

9

1378

Mean Difference (IV, Fixed, 95% CI)

‐9.08 [‐15.85, ‐2.30]

4 Hospital length of stay Show forest plot

5

977

Mean Difference (IV, Fixed, 95% CI)

‐1.32 [‐3.09, 0.44]

Figures and Tables -
Comparison 3. Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data