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The Efficacy and Safety of Prone Positional Ventilation in Acute Respiratory Distress Syndrome: Updated Study-Level Meta-Analysis of 11 Randomized Controlled Trials*

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The Efficacy and Safety of Prone Positional Ventilation in Acute Respiratory Distress Syndrome: Updated Study-Level Meta-Analysis of 11 Randomized Controlled Trials* Review Articles The Efficacy and Safety of Prone Positional Ventilation in Acute Respiratory Distress Syndrome: Updated Study-Level Meta-Analysis of 11 Randomized Controlled Trials* Joo Myung Lee, MD, MPH1; Won Bae, MD2; Yeon Joo Lee, MD2; Young-Jae Cho, MD, MPH2 Objective: The survival benefit of prone positioning during mechani- the effects were marked in the subgroup in which the duration cal ventilation for acute respiratory distress syndrome has been a of prone positioning was more than 10 hr/session, compared matter of debate. Recent multicenter randomized controlled trials with the subgroup with a short-term duration of prone position- have shown a significant reduction of 28-day and 90-day mortal- ing (odds ratio, 0.62; 9% CI, 0.48–0.79; p = 0.039; pinteraction = ity associated with prone positioning during mechanical ventilation 0.015). Prone positioning was significantly associated with pres- for severe acute respiratory distress syndrome. We performed an sure ulcers (odds ratio, 1.49; 95% CI, 1.18–1.89; p = 0.001; up-to-date meta-analysis on this topic and elucidated the effect of I2 = 0.0%) and major airway problems (odds ratio, 1.55; 95% CI, prone positioning on overall mortality and associated complications. 1.10–2.17; p = 0.012; I2 = 32.7%). Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Conclusions: Ventilation in the prone position significantly reduced Central Register of Controlled Trials, ClinicalTrials.gov, and con- overall mortality in patients with severe acute respiratory distress ference proceedings through May 2013. syndrome. Sufficient duration of prone positioning was signifi- Study Selection: Randomized controlled trial comparing overall cantly associated with a reduction in overall mortality. Prone ven- mortality of prone-versus-supine positioning in patients with acute tilation was also significantly associated with pressure ulcers and respiratory distress syndrome. major airway problems. (Crit Care Med 2014; 42:1252–1262) Data Extraction: Data were extracted for populations, interven- Key Words: acute lung injury; acute respiratory distress syndrome; tions, outcomes, and risk of bias. The prespecified primary end- meta-analysis; prone position; randomized controlled trial point was overall mortality, using the longest available follow-up in each study. The odds ratio with 95% CI was the effect measure. Data Synthesis: This analysis included 11 randomized controlled trial, 2,246 total adult patients, and 1,142 patients ventilated in rone positioning during mechanical ventilation for the prone position. Prone positioning during ventilation signifi- acute respiratory distress syndrome (ARDS) has a robust cantly reduced overall mortality in the random-effect model (odds Pscientific background. Previous randomized controlled ratio, 0.77; 95% CI, 0.59–0.99; p = 0.039; I2 = 33.7%), and trials (RCTs) have demonstrated that prone positioning results in a significant improvement of oxygenation in patients with acute hypoxemic respiratory failure, as measured by the ratio O IO *See also p. 1318. of Pa 2 to the F 2 (1–3). Despite these physiologic benefits, sev- 1Division of Cardiology, Department of Internal Medicine and Cardiovas- eral RCTs reported no improvement of patient survival with cular Center, Seoul National University Hospital, Seoul, Korea. prone positioning (1, 2, 4, 5). However, post hoc analysis of the 2Division of Pulmonary and Critical Care Medicine, Department of Internal first RCT carried out by Gattinoni et al (1), which compared Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. prone and supine ventilation in patient with acute respiratory Supplemental digital content is available for this article. Direct URL cita- failure, demonstrated that prone positioning reduced mor- tions appear in the printed text and are provided in the HTML and PDF tality by 10 days in the subgroup of patients with the highest versions of this article on the journal’s website (http://journals.lww.com/ disease severity (Simplified Acute Physiology Score [SAPS II] ccmjournal). ≥ 50). Furthermore, selected meta-analyses, which included The authors have disclosed that they do not have any potential conflicts O of interest. the severest subgroup of patients (by SAPS II score or Pa 2/ IO For information regarding this article, E-mail: [email protected] F 2 < 100 mm Hg), revealed similar findings (6–8). A recently Copyright © 2014 by the Society of Critical Care Medicine and Lippincott published multicenter trial by Guérin et al (9) showed signifi- Williams & Wilkins cant mortality reduction associated with prone positioning O IO DOI: 10.1097/CCM.0000000000000122 for patients with severe ARDS, as defined by Pa 2/F 2 less than 1252 www.ccmjournal.org May 2014 • Volume 42 • Number 5 Review Articles or equal to 150 mm Hg with positive end-expiratory pressure Society of Critical Care Medicine (1994–2013), the European (PEEP) more than or equal to 5 cm H2O. Society of Intensive Care Medicine (1994–2013), the American We performed a systematic review and comprehensive College of Chest Physicians (1994–2013), and the International meta-analysis of RCTs to compare the efficacy (reduction of Symposium on Intensive Care and Emergency Medicine (1997– overall mortality) and safety (adverse events) of prone versus 2013). There was no language restriction (12). supine positioning during mechanical ventilation for ARDS. We also evaluated a chronological trend of pooled estimates of Study Selection prone positioning by cumulative meta-analysis and the effect We included studies that met the following criteria: adult O IO of strength of the intervention (i.e., actual duration of prone patients with acute hypoxemic respiratory failure (Pa 2/F 2 positioning) to the pooled estimates by meta-regression. ≤ 300 mm Hg), including acute lung injury (ALI) and ARDS, who were under mechanical ventilatory support; all stud- ies that randomly assigned patients to two or more groups, METHODS including prone or supine positioning, during ventilation; Data Sources and Searches and all-cause mortality was reported regardless of the timing Pertinent published or unpublished studies were independently of data collection. We excluded RCTs conducted on pediatric searched in PubMed, EMBASE, BioMed Central, Cochrane Cen- patients and randomized crossover trials that assigned patients tral Register of Controlled Trials, and the United States National to both prone and supine groups. Institutes of Health registry of clinical trials (http://www.clini- caltrials.gov), using the following MeSH and key word terms: Data Extraction and Quality Assessment “acute respiratory distress syndrome” or “acute lung injury,” Summary data as reported in the published articles were used in and “prone position” or “prone positioning,” and “randomized the analysis. A standardized form was used to extract trial char- controlled trial” or “randomized trial” or “randomized clinical acteristics, study design (including randomization sequence trial” (10, 11). Additional data sources included conference pro- generation, allocation concealment, crossover between assigned ceedings from the American Thoracic Society (1994–2013), the groups, number of postrandomization withdrawals, or lost to Figure 1. Flow diagram of trial selection. The study flow diagram was depicted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. ALI = acute lung injury, ARDS = acute respiratory distress syndrome, RCT = randomized controlled trial. Critical Care Medicine www.ccmjournal.org 1253 Lee et al TABLE 1. Characteristics of the Randomized Controlled Trials Included in this Study Gattinoni et al (1) Voggenreiter Fernandez Taccone et al (5) Guérin et al (9) Variable (Prone-Supine I) Beuret et al (19) Guerin et al (2) et al (3) Papazian et al (23) Mancebo et al (4) Chan et al (20) Demory et al (21) et al (22) (Prone-Supine II) (PROSEVA) Populations Total n 304 53 802 40 26 142 22 28 42 344 474 Enrollment period 1996–1999 1997–2000 1998–2002 1999–2001 Uncertain 1998–2002 2002–2003 2003–2004 2003–2004 2004–2008 2008–2011 O IO Enrollment criteria ALI/ARDS with Intubated ALI (Pa 2/F 2 Traumatic ALI/ ARDS only with ARDS only with ARDS due to ARDS only with ARDS only with ARDS only with Severe ARDS O IO O IO O IO O IO O IO O IO and definition in Pa 2/F 2 coma, ≤ 300) or ARDS with Pa 2/F 2 ≤ 150 Pa 2/F 2 pneumonia Pa 2/F 2 < Pa 2/F 2 ≤ 200 Pa 2/F 2 ≤ only with O O IO O IO the trials ≤ 200 with severe ARDS (Pa 2/ Pa 2/F 2 ≤ with PEEP 5 cm ≤ 200 with only with 150 with PEEP with PEEP ≥ 200 with PEEP Pa 2/F 2 < IO O IO IO PEEP ≥ 5 cm hypoxemia F 2 ≤ 200) 200 with PEEP H2O, PAOP ≤ PEEP ≥ 5 cm Pa 2/F 2 ≥ 5 cm H2O, 5 cm H2O, PAOP ≥ 5 cm H2O, 150 with F 2 O O H2O or Pa 2/ (Pa 2/ ≥ 5 cm H2O 18 mm Hg H2O, PAOP ≤ ≤ 200 with PAOP ≤ 18 mm ≤ 18 mm Hg PAOP ≤ 18 mm ≥ 0.6, PEEP IO IO O IO F 2 ≤ 300 with F 2 ≤ or Pa 2/F 2 ≤ 18 mm Hg PEEP ≥ 5 cm Hg Hg ≥ 5 cm H2O, PEEP ≥ 10 cm 150) was 300 with PEEP H2O, PAOP ≤ VT 6 mL/kg H2O, PAOP ≤ excluded ≥ 5 cm H2O, 18 mm Hg (PBW) 18 mm Hg PAOP ≤ 18 mm Hg Disease ALI/ARDS ALI/ARDS ALI/ARDS ALI/ARDS ARDS (100%) ARDS (100%) ARDS (100%) ARDS (100%) ARDS (100%) ARDS (100%) ARDS (100%) (6%/94%) (7 patients, (21%/31%) (45%/55%) 13.2%) Mean age (yr) 58 55 62.2 41.4 53 54 62.3 50.9 54.6 60 59 Randomization O IO Stratified by No No No No No No No No Yes (SAPS II) Yes (Pa 2/F 2) No severity Allocation Centrally by Sealed Sealed opaque Centrally by Sealed opaque Sealed opaque No Sealed
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