Prone position for acute respiratory failure in adults

Roxanna Bloomfield; David W Noble; Alexis Sudlow

doi:10.1002/14651858.CD008095.pub2

Cochrane Database of Systematic Reviews

Decúbito prono para la insuficiencia respiratoria aguda en adultos

Información

DOI:

https://doi.org/10.1002/14651858.CD008095.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

13 noviembre 2015see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Atención crítica y de emergencia

Copyright:

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Roxanna Bloomfield

Intensive Care Unit and Department of Anaesthesia, Aberdeen Royal Infirmary, Aberdeen, UK
David W Noble

Correspondencia a: Intensive Care Unit and Department of Anaesthesia, Aberdeen Royal Infirmary, Aberdeen, UK

[email protected]

[email protected]
Alexis Sudlow

Luton and Dunstable Hospital, Luton, UK

Contributions of authors

Conceiving of the review: Roxanna Bloomfield (RB), David W. Noble (DWN).
Co‐ordinating the review: RB, DWN.
Undertaking manual searches: RB, DWN.
Screening search results: RB, DWN.
Organizing retrieval of papers: RB, DWN.
Screening retrieved papers against inclusion criteria: RB, DWN.
Appraising quality of papers: RB, DWN, Alexis Sudlow (AS).
Abstracting data from papers: RB, DWN, AS.
Writing to authors of papers for additional information: DWN.
Providing additional data about papers:
Obtaining and screening data on unpublished studies: RB, DWN.
Managing data for the review: RB, DWN.
Entering data into Review Manager (RevMan 5.40): RB, DWN, AS.
Analysing RevMan statistical data: DWN.
Performing other statistical analyses not using RevMan: DWN
Performing double entry of data: (data entered by person one: RB; data entered by person two: DWN).
Interpreting data: RB, DWN, AS.
Making statistical inferences: RB, DWN.
Writing the review: RB, DWN, AS.
Securing funding for the review:
Performing previous work that served as the foundation of the present study:
Serving as guarantor for the review (one review author): DWN.
Taking responsibility for reading and checking the review before submission: AS.

Sources of support

Internal sources

NHS Grampian, UK

External sources

No sources of support supplied

Declarations of interest

Roxanna Bloomfield: none known.

David W Noble: none known.

Alexis Sudlow: none known.

Acknowledgements

We would like to thank Dr Harald Herkner (Content Editor) and Dr Claude Guerin and Dr Spyros D. Mentzelopoulos (Peer Reviewers) for help and editorial advice provided during preparation of the protocol (Bloomfield 2009).

In addition, we would like to thank Dr Harald Herkner (Content Editor); Nathan Pace (Statistical Editor); Jean‐Louis Vincent, Spyros D Mentzelopoulos and Thordis Thomsen (Peer Reviewers); and Anne Lyddiatt (Consumer) for help and editorial advice provided during preparation of the original version of this systematic review (Bloomfield 2015).

We would like to thank Xuan Yu, Qiangqiang Guo for their assistance with study translation. We also thank Dr Zhou Quanhong MSc MD PhD for assessment and translation of some studies published in Chinese.

Finally we wish to acknowledge the invaluable assistance of Teo Aminah Wasteneys Quay and Janne Vendt for this update as well as the enormous amount encouragement and help of Jane Cracknell in preparation of the original version of this Cochrane Review. Insert full acknowledgements for this update.

Version history

Published

Title

Stage

Authors

Version

2015 Nov 13

Prone position for acute respiratory failure in adults

Review

Roxanna Bloomfield, David W Noble, Alexis Sudlow

https://doi.org/10.1002/14651858.CD008095.pub2

2009 Oct 07

Prone position for acute respiratory failure in adults

Protocol

Roxanna Bloomfield, David W Noble, Nigel R Webster

https://doi.org/10.1002/14651858.CD008095

Differences between protocol and review

We made the following changes to the protocol (Bloomfield 2009).

We replaced Nigel Webster, who had insufficient time to assist with the review process, with Alexis Sudlow.
We added references and Background text.
We made the definition of tidal volume more specific for the purpose of identifying studies that employed "lung‐protective ventilation" (i.e. tidal volume should be expressed in mL per kg of ideal body weight.
Risk of bias methods for a Cochrane review have changed since protocol publication, and we reanalysed data for the new format.
The GRADE‐based summary of findings table has been introduced since protocol publication, and we have therefore retrospectively chosen the analyses displayed.
We did not employ the Q‐partitioning method (Deeks 2011) in exploring heterogeneity and used the I² approach recommended instead.
We made minor modifications to search strategies for Ovid MEDLINE, EMBASE, CENTRAL, CINAHL and LILACS to better suit their updated search engines.
We changed the cutoff for prolonged duration of prone positioning from 18 or more hours per day to 16 or more hours per day. This placed the last published study (Guerin 2013) in the more biologically appropriate category for analysis. (The mean duration of proning in the short‐duration proning group was 8.3 hours per day, and for the long‐duration proning group 18.1 hours per day, and one study aiming for 20 hours per day actually achieved 17 hours per day (Mancebo 2006). The study of Guerin et al (Guerin 2013) also achieved proning for a mean of 17 hours per day.)

Notes

The present interim amendment includes an updated search (May 2020, no new trials identified), and search of trial registries (November 2020, 3 ongoing studies identified). Review text was updated to reflect advances in knowledge since the original review and the availability of new data from secondary analyses; however, a complete update of this review is pending.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans; Middle Aged;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Flow diagram of results from updated search (January 2014 to 1st May 2020)

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Figure 2

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

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Figure 3

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

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Figure 4

Funnel plot of comparison: 1 Mortality, outcome: 1.1 Mortality.

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Figure 5

Primary RCTs incorporated in various published Systematic Reviews.

Green denotes primary study was incorporated; Pink denotes primary study was not utilised; Yellow denotes primary study was not available to reviewers. *Yue_17 also included non‐RCT.

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Analysis 1.1

Comparison 1: Mortality, Outcome 1: Mortality

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Analysis 1.2

Comparison 1: Mortality, Outcome 2: Sub‐group analysis (SGA) of mortality < 16 hours/d prone

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Analysis 1.3

Comparison 1: Mortality, Outcome 3: SGA of mortality prone ≥ 16 hours/d

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Analysis 1.4

Comparison 1: Mortality, Outcome 4: SGA of mortality: enrolled ≤ 48 hours after entry criteria met/ventilation

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Analysis 1.5

Comparison 1: Mortality, Outcome 5: SGA of mortality: enrolled > 48 hours after entry criteria met/ventilation

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Analysis 1.6

Comparison 1: Mortality, Outcome 6: SGA of severe hypoxaemia at entry

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Analysis 1.7

Comparison 1: Mortality, Outcome 7: SGA of less severe hypoxaemia at entry

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Analysis 1.8

Comparison 1: Mortality, Outcome 8: SGA of SAPS II ≤ 49/≥ 50: short‐term mortality

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Analysis 1.9

Comparison 1: Mortality, Outcome 9: SGA of low tidal volume (mean 6 to 8 mL/kg IBW)

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Analysis 1.10

Comparison 1: Mortality, Outcome 10: SGA of high tidal volume (> 8 mL/kg IBW)

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Analysis 1.11

Comparison 1: Mortality, Outcome 11: SGA of ARDS only

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Analysis 2.1

Comparison 2: Intervention comparisons and interactions, Outcome 1: Longer duration vs shorter duration of proning: longer‐term mortality

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Analysis 2.2

Comparison 2: Intervention comparisons and interactions, Outcome 2: Early enrolment vs later enrolment to intervention: longer‐term mortality

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Analysis 2.3

Comparison 2: Intervention comparisons and interactions, Outcome 3: Severe vs less‐severe hypoxaemia: longer‐term mortality

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Analysis 2.4

Comparison 2: Intervention comparisons and interactions, Outcome 4: Lower tidal volume (TV) ventilation vs higher TV ventilation: longer‐term mortality

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Analysis 3.1

Comparison 3: Pneumonia, Outcome 1: Pneumonia

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Analysis 4.1

Comparison 4: Duration of mechanical ventilation, Outcome 1: Duration of mechanical ventilation

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Analysis 5.1

Comparison 5: Length of stay (LOS), Outcome 1: ICU LOS

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Comparison 6: Mean change in PaO2/FIO2 quotient (mmHg), Outcome 1: Mean increase in PaO2/FIO2 quotient (mmHg) at 7 or 10 days

Analysis 6.1

Comparison 6: Mean change in PaO₂/FIO₂ quotient (mmHg), Outcome 1: Mean increase in PaO₂/FIO₂ quotient (mmHg) at 7 or 10 days

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Analysis 7.1

Comparison 7: Adverse events, Outcome 1: Adverse events

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Summary of findings 1. Mortality: prone position compared with supine for acute respiratory failure in adults requiring mechanical ventilation in intensive care

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)
Mortality: prone position compared with supine for acute respiratory failure in adults requiring mechanical ventilation in intensive care
Patient or population: adults with acute respiratory failure Settings: Intervention: mortality: prone position compared with supine
	Assumed risk	Corresponding risk
	Control	Mortality: prone position compared with supine
Short‐term mortality (STM) Alive or dead Follow‐up: 10 to 30 days	Study population		RR 0.84 (0.69 to 1.02)	2117 (8 studies)	⊕⊕⊝⊝ Low^a,b
	383 per 1000	322 per 1000 (264 to 391)
	Moderate
	450 per 1000	378 per 1000 (310 to 459)
Longer‐term mortality (LTM) Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.86 (0.72 to 1.03)	2141 (8 studies)	⊕⊕⊝⊝ Low^a,b
	470 per 1000	404 per 1000 (339 to 484)
	Moderate
	525 per 1000	452 per 1000 (378 to 541)
Subgroup analysis of longer‐term mortality: severe hypoxaemia Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.77 (0.65 to 0.92)	977 (7 studies)	⊕⊕⊕⊝ Moderate^a
	547 per 1000	421 per 1000 (356 to 503)
	Moderate
	653 per 1000	503 per 1000 (424 to 601)
Subgroup analysis of longer‐term mortality: lower tidal volume ventilation Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.73 (0.55 to 0.96)	911 (5 studies)	⊕⊕⊕⊝ Moderate^a
	451 per 1000	329 per 1000 (248 to 433)
	Moderate
	523 per 1000	382 per 1000 (288 to 502)
Subgroup analysis of longer‐term mortality: ARDS only Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.85 (0.71 to 1.01)	1758 (8 studies)	⊕⊕⊕⊝ Moderate^a
	483 per 1000	411 per 1000 (343 to 488)
	Moderate
	522 per 1000	444 per 1000 (371 to 527)
Subgroup analysis of longer‐term mortality: ≥ 16 hours/d prone Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.77 (0.61 to 0.99)	1005 (5 studies)	⊕⊕⊕⊝ Moderate^a
	470 per 1000	362 per 1000 (286 to 465)
	Moderate
	526 per 1000	405 per 1000 (321 to 521)
Subgroup analysis of longer‐term mortality: enrolment ≤ 48 hours after entry criteria/ventilation Alive or dead Follow‐up: 31 to 180 days^c	Study population		RR 0.75 (0.59 to 0.94)	1024 (5 studies)	⊕⊕⊕⊝ Moderate^a
	469 per 1000	352 per 1000 (277 to 441)
	Moderate
	523 per 1000	392 per 1000 (309 to 492)
The basis for the assumed risk* (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate Very low quality: We are very uncertain about the estimate
^aBlinding of participants and carers was not possible. Researchers also may not have been adequately blinded. All analyses were downgraded because of this important potential bias, leading the quality of all subgroup analyses to be rated as moderate ^bFor the primary outcomes, inconsistency across studies reflected different patient populations, different management strategies generally and differences in adaptations to resulting effects of the intervention. This led to further downgrading of the quality of evidence for the primary outcomes to low ^cLonger‐term mortality = 31 to 180 days OR hospital mortality

Summary of findings 1. Mortality: prone position compared with supine for acute respiratory failure in adults requiring mechanical ventilation in intensive care

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Comparison 1. Mortality

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Mortality Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1.1 Short‐term mortality	8	2117	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.69, 1.02]
1.1.2 Longer‐term mortality	8	2140	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.72, 1.03]
1.2 Sub‐group analysis (SGA) of mortality < 16 hours/d prone Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.2.1 Short‐term mortality	2	1095	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.89, 1.21]
1.2.2 Longer‐term mortality	3	1135	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.92, 1.17]
1.3 SGA of mortality prone ≥ 16 hours/d Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.3.1 Short‐term mortality	6	1022	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.58, 0.93]
1.3.2 Longer‐term mortality prone	5	1005	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.61, 0.99]
1.4 SGA of mortality: enrolled ≤ 48 hours after entry criteria met/ventilation Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.4.1 Short‐term mortality	5	1000	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.56, 0.93]
1.4.2 Longer‐term mortality	5	1024	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.59, 0.94]
1.5 SGA of mortality: enrolled > 48 hours after entry criteria met/ventilation Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.5.1 Short‐term mortality	3	1117	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.89, 1.21]
1.5.2 Longer‐term mortality	3	1116	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.92, 1.17]
1.6 SGA of severe hypoxaemia at entry Show forest plot	8		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.6.1 Short‐term mortality	6	744	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.70, 0.95]
1.6.2 Longer‐term mortality	7	977	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.65, 0.92]
1.7 SGA of less severe hypoxaemia at entry Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.7.1 Short‐term mortality	4	1095	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.87, 1.21]
1.7.2 Longer‐term mortality	6	1108	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.93, 1.21]
1.8 SGA of SAPS II ≤ 49/≥ 50: short‐term mortality Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.8.1 SAPS II ≤ 49	2	327	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.45, 1.60]
1.8.2 SAPS II ≥ 50	2	113	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.25, 1.40]
1.9 SGA of low tidal volume (mean 6 to 8 mL/kg IBW) Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.9.1 Short‐term mortality	3	830	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.43, 1.20]
1.9.2 Longer‐term mortality	5	911	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.55, 0.96]
1.10 SGA of high tidal volume (> 8 mL/kg IBW) Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.10.1 Short‐term mortality	3	1231	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.86, 1.14]
1.10.2 Longer‐term mortality	3	1231	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.90, 1.13]
1.11 SGA of ARDS only Show forest plot	9		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.11.1 Short‐term mortality	7	1326	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.63, 1.00]
1.11.2 Longer‐term mortality	8	1758	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.71, 1.01]

Comparison 1. Mortality

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Comparison 2. Intervention comparisons and interactions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Longer duration vs shorter duration of proning: longer‐term mortality Show forest plot	8	2140	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.73, 1.04]

2.1.1 > 16 hours	5	1005	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.61, 0.99]
2.1.2 ≤ 16 hours prone	3	1135	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.18]
2.2 Early enrolment vs later enrolment to intervention: longer‐term mortality Show forest plot	8	2140	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.72, 1.03]

2.2.2 Late enrolment > 48 hours	3	1116	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.92, 1.17]
2.2.3 Early enrolment ≤ 48 hours	5	1024	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.59, 0.94]
2.3 Severe vs less‐severe hypoxaemia: longer‐term mortality Show forest plot	7	2085	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.76, 1.03]

2.3.1 Severe hypoxaemia	7	977	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.65, 0.92]
2.3.2 Less severe hypoxaemia	6	1108	Risk Ratio (M‐H, Random, 95% CI)	1.07 [0.92, 1.26]
2.4 Lower tidal volume (TV) ventilation vs higher TV ventilation: longer‐term mortality Show forest plot	8	2183	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.72, 1.01]

2.4.1 Lower TV ‐ mean 6 to 8 mL/kg IBW	5	911	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.55, 0.96]
2.4.2 High TV ‐ mean > 8 mL/kg IBW	4	1272	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.88, 1.12]

Comparison 2. Intervention comparisons and interactions

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Comparison 3. Pneumonia

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Pneumonia Show forest plot	5	1473	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.80, 1.18]

Comparison 3. Pneumonia

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Comparison 4. Duration of mechanical ventilation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Duration of mechanical ventilation Show forest plot	3	871	Mean Difference (IV, Fixed, 95% CI)	‐0.47 [‐1.53, 0.59]

Comparison 4. Duration of mechanical ventilation

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Comparison 5. Length of stay (LOS)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 ICU LOS Show forest plot	5	1775	Mean Difference (IV, Fixed, 95% CI)	1.06 [‐1.13, 3.26]

Comparison 5. Length of stay (LOS)

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Comparison 6. Mean change in PaO2/FIO2 quotient (mmHg)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Mean increase in PaO₂/FIO₂ quotient (mmHg) at 7 or 10 days Show forest plot	4	827	Mean Difference (IV, Fixed, 95% CI)	24.03 [13.35, 34.71]

6.1.1 Change data provided	2	268	Mean Difference (IV, Fixed, 95% CI)	16.71 [0.11, 33.32]
6.1.2 Calculated change data	2	559	Mean Difference (IV, Fixed, 95% CI)	29.19 [15.24, 43.14]

Comparison 6. Mean change in PaO2/FIO2 quotient (mmHg)

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Comparison 7. Adverse events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Adverse events Show forest plot	10		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1.1 Pressure ulcers	4	823	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [1.06, 1.48]
7.1.2 Tracheal tube displacement	8	2021	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.85, 1.39]
7.1.3 Tracheal tube obstruction	3	1597	Risk Ratio (M‐H, Fixed, 95% CI)	1.72 [1.35, 2.18]
7.1.4 Pneumothorax	4	664	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.65, 2.08]
7.1.5 Arrhythmias	3	642	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.47, 0.87]

Comparison 7. Adverse events

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Decúbito prono para la insuficiencia respiratoria aguda en adultos

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