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. 2023 Dec 26;330(24):2343-2353.
doi: 10.1001/jama.2023.24491.

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

Matthieu Schmidt  1   2   3 , David Hajage  4 , Guillaume Lebreton  1   5 , Martin Dres  3   6 , Christophe Guervilly  7 , Jean Christophe Richard  8 , Romain Sonneville  9 , Hadrien Winiszewski  10 , Gregoire Muller  11 , Gaëtan Beduneau  12 , Emmanuelle Mercier  13 , Hadrien Roze  14 , Mathieu Lesouhaitier  15 , Nicolas Terzi  16 , Arnaud W Thille  17 , Isaura Laurent  4 , Antoine Kimmoun  18 , Alain Combes  1   2   3 ; PRONECMO Investigators, the REVA Network, and the International ECMO Network (ECMONet)
Collaborators, Affiliations

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

Matthieu Schmidt et al. JAMA. .

Erratum in

  • Errors in Percentage Calculations.
    [No authors listed] [No authors listed] JAMA. 2024 Feb 6;331(5):446. doi: 10.1001/jama.2024.0231. JAMA. 2024. PMID: 38319343 Free PMC article. No abstract available.

Abstract

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 H2O; 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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Schmidt reported receipt of lecture fees from Getinge, Dräger, Baxter, and Fresenius Medical Care. Dr Dres reported receipt of personal fees from Lungpacer Medical Inc. Dr Guervilly reported receipt of personal fees from Xenios FMC. Dr Sonneville reported receipt of grants from the French Ministry of Health and LFB. Dr Thille reported receipt of grants from the French Ministry of Health and receipt of personal fees (payment for lectures and travel/accommodation to attend scientific meetings) and nonfinancial support from Fisher & Paykel and GE Healthcare. Dr Combes reported receipt of grants from Getinge and personal fees from Getinge, Baxter, and Xenios. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participant Flow in the PRONECMO Trial
ARDS indicates acute respiratory distress syndrome; SAPS II, Simplified Acute Physiology Score; and VV-ECMO, venovenous extracorporeal membrane oxygenation.
Figure 2.
Figure 2.. Cumulative Incidence of Successful ECMO Weaning, Weaning Failure, and Death, by Positioning Group
Weaning failure was defined as need for a second extracorporeal membrane oxygenation (ECMO) run or lung transplant or death within 30 days after ECMO discontinuation. Among patients with ECMO weaning failure, 8 in the prone ECMO group and 2 in the supine ECMO group were weaned from ECMO but died within 30 days after ECMO discontinuation, 1 patient in each group needed a second ECMO run within 30 days after ECMO discontinuation, and none had a lung transplant. aEvents refer to death, successful weaning, or weaning failure.
Figure 3.
Figure 3.. Subdistribution Hazard Ratios for the Primary Outcome of Successful ECMO Weaning in Predefined or Post Hoc Subgroups of Patients Randomized to Prone or Supine Positioning During ECMO
Successful extracorporeal membrane oxygenation (ECMO) weaning was assessed within 60 days following randomization. ECMO weaning (ie, ECMO discontinuation) was considered successful only if a patient survived without a second ECMO run or lung transplant within 30 days after ECMO discontinuation. Body mass index was calculated as weight in kilograms divided by height in meters squared. aUsing Fine and Gray models. bPreplanned analysis. Respiratory system compliance measures the ability of the lungs to expand and accommodate changes in volume (ie, elasticity) in response to changes in pressure. It is expressed as tidal volume/(plateau pressure − positive end-expiratory pressure). cPost hoc subgroup analysis. dHigh volume was defined as inclusion of more than 30 patients in the study from that center.
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