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Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial.

Authors :
Schmidt, Matthieu
Hajage, David
Lebreton, Guillaume
Dres, Martin
Guervilly, Christophe
Richard, Jean Christophe
Sonneville, Romain
Winiszewski, Hadrien
Muller, Gregoire
Beduneau, Gaëtan
Mercier, Emmanuelle
Roze, Hadrien
Lesouhaitier, Mathieu
Terzi, Nicolas
Thille, Arnaud W.
Laurent, Isaura
Kimmoun, Antoine
Combes, Alain
Source :
JAMA: Journal of the American Medical Association; 12/26/2023, Vol. 330 Issue 24, p2343-2353, 11p
Publication Year :
2023

Abstract

Key Points: Question: Prone positioning may improve the outcome of patients with severe acute respiratory distress syndrome (ARDS), but is prone position superior to supine position among patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) for severe ARDS? Findings: In this randomized clinical trial that included 170 patients primarily with COVID-19 who were undergoing VV-ECMO, successful ECMO weaning at day 60 occurred in 38 patients (44%) in the prone ECMO group compared with 37 patients (44%) in the supine ECMO group, a nonsignificant difference (subdistribution hazard ratio, 1.11). Meaning: Among patients with severe ARDS undergoing VV-ECMO, prone positioning did not reduce time to successful ECMO weaning compared with supine position. Importance: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning. Objective: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO. Design, Setting, and Participants: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021. Interventions: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84). Main Outcomes and Measures: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up. Results: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H<subscript>2</subscript>O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P =.64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P =.13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 2.4% [95% CI, −13.9% to 18.6%]; P =.62). No serious adverse events were reported during the prone position procedure. Conclusions and Relevance: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO. Trial Registration: ClinicalTrials.gov Identifier: NCT04607551 This randomized trial assesses whether prone vs supine positioning decreases the time to successful weaning of extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS). [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00987484
Volume :
330
Issue :
24
Database :
Complementary Index
Journal :
JAMA: Journal of the American Medical Association
Publication Type :
Academic Journal
Accession number :
174530873
Full Text :
https://doi.org/10.1001/jama.2023.24491