PRONECMO
Trial question
What is the role of prone positioning in patients with severe ARDS supported by venovenous ECMO?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 170
170 patients (60 female, 110 male).
Inclusion criteria: patients with severe ARDS undergoing venovenous ECMO for < 48 hours.
Key exclusion criteria: age < 18 years or > 75 years; pregnancy and lactation; initiation of venovenous ECMO > 48 hours prior; end-stage chronic lung disease; ARDS secondary to abdominal surgery; a moribund condition or a Simplified Acute Physiology Score value > 90; contraindications for prone positioning.
Interventions
N=86 prone ECMO (placement in a prone position during ECMO for at least four 16-hour sessions during the first 4 days).
N=84 supine ECMO (placement in a supine position for the duration of ECMO).
Primary outcome
Rate of successful extracorporeal membrane oxygenation weaning by day 60
44.2%
44%
44.2 %
33.2 %
22.1 %
11.1 %
0.0 %
Prone extracorporeal membrane
oxygenation
Supine extracorporeal membrane
oxygenation
No significant
difference ↔
No significant difference in the rate of successful ECMO weaning by day 60 (44.2% vs. 44%; HR 1.11, 95% CI 0.71 to 1.75).
Secondary outcomes
No significant difference in the rate of pneumothorax by day 60 (16% vs. 21%; RR 0.8, 95% CI 0.42 to 1.53).
No significant difference in death at day 90 (51% vs. 48%; RR 1.1, 95% CI 0.72 to 1.69).
No significant difference in mean days receiving ECMO during first 90 days (27.51 days vs. 32.19 days; MD -4.9, 95% CI -11.2 to 1.5).
Safety outcomes
No significant differences in bleeding event requiring packed RBC transfusion, hemorrhagic stroke.
Significant difference in ≥ 1 cardiac arrest by day 60 (3.5% vs. 13.1%).
Conclusion
In patients with severe ARDS undergoing venovenous ECMO for < 48 hours, prone ECMO was not superior to supine ECMO with respect to the rate of successful ECMO weaning by day 60.
Reference
Matthieu Schmidt, David Hajage, Guillaume Lebreton et al. Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial. JAMA. 2023 Dec 26;330(24):2343-2353.
Open reference URL