PROSEVA
Trial question
What is the role of prone positioning in patients with severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 466
466 patients (148 female, 318 male).
Inclusion criteria: patients undergoing mechanical ventilation for severe ARDS.
Key exclusion criteria: contraindication for prone positioning, lung transplantation, underlying disease with a life expectancy of < 1 year, or end-of-life decision before inclusion.
Interventions
N=237 performing prone-positioning sessions (within the first hour after randomization for at least 16 consecutive hours).
N=229 standard supine positioning (remained in semirecumbent position).
Primary outcome
Death at 28 days
16%
32.8%
32.8 %
24.6 %
16.4 %
8.2 %
0.0 %
Performing prone-positioning
sessions
Standard supine
positioning
Significant
decrease ▼
NNT = 5
Significant decrease in death at 28 days (16% vs. 32.8%; HR 0.39, 95% CI 0.25 to 0.63).
Secondary outcomes
Significant decrease in death at 90 days (23.6% vs. 41%; HR 0.44, 95% CI 0.29 to 0.67).
Significant decrease in successful extubation at 90 day (80.5% vs. 65%; HR 0.45, 95% CI 0.29 to 0.7).
Safety outcomes
No significant differences in overall incidence of complications, with the exception of cardiac arrest, which was more common in the supine group.
Conclusion
In patients undergoing mechanical ventilation for severe ARDS, performing prone-positioning sessions were superior to standard supine positioning with respect to death at 28 days.
Reference
Guerin C, Reignier J, Richard JC et al. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68.
Open reference URL