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

Bronagh Blackwood; Karen EA Burns; Chris R Cardwell; Peter O'Halloran

doi:10.1002/14651858.CD006904.pub3

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Figure 1

Updated study flow diagram.

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Figure 2

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

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Figure 3

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

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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].

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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].

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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].

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Analysis 1.1

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

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Analysis 1.2

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

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Analysis 1.3

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

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Analysis 1.4

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

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Analysis 1.5

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

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Analysis 1.6

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

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Analysis 1.7

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

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Analysis 1.8

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

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Analysis 1.9

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

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Analysis 1.10

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

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Analysis 1.11

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

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Analysis 1.12

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

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Analysis 1.13

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

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Analysis 1.14

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

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Analysis 2.1

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

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Analysis 2.2

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

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Analysis 3.1

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

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Analysis 3.2

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

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Analysis 3.3

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

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Analysis 3.4

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

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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)
Outcomes	Assumed risk non‐protocolized weaning	Corresponding risk protocolized weaning	Effect Estimates (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
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%).

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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 < 38.5^oC	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 < 37.8^oC	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 ‐ 39^oC	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 < 38^oC	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 </= 37^oC	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.

Table 1. Readiness to wean criteria

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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 SmartCare^TM/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 SmartCare^TM/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 SmartCare^TM/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.

Table 2. Weaning protocol differences

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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]

Comparison 1. Primary analysis: protocolized versus non‐protocolized weaning

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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]

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

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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]

Comparison 3. Sensitivity analysis: protocolized versus non‐protocolized weaning, unlogged data

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