COVI-PRONE
Trial question
What is the role of awake prone positioning in patients with COVID-19 and acute respiratory failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 400
400 patients (117 female, 283 male).
Inclusion criteria: nonintubated adult patients with acute hypoxemia and COVID-19.
Key exclusion criteria: receipt of invasive mechanical ventilation; contraindications to prone positioning; at risk of complications from prone positioning; prior self-prone positioning.
Interventions
N=205 prone positioning (awake prone positioning sessions for 8-10 hours/day with usual care).
N=195 usual care (usual care alone).
Primary outcome
Rate of endotracheal intubation within 30 days
34.1%
40.5%
40.5 %
30.4 %
20.3 %
10.1 %
0.0 %
Prone
positioning
Usual
care
No significant
difference ↔
No significant difference in the rate of endotracheal intubation within 30 days (34.1% vs. 40.5%; HR 0.81, 95% CI 0.59 to 1.12).
Secondary outcomes
No significant difference in death at day 60 (22% vs. 24%; HR 0.93, 95% CI 0.62 to 1.4).
No significant difference in days free from invasive mechanical ventilation or noninvasive ventilation at day 30 (21.4% vs. 19.4%; MD 2.04, 95% CI -0.5 to 4.59).
No significant difference in hospital free days at day 60 (34.4% vs. 30.8%; MD 3.52, 95% CI -1.05 to 8.08).
Safety outcomes
Significant difference in adverse events including musculoskeletal pain or discomfort from prone positioning (10% vs. 0%).
Conclusion
In nonintubated adult patients with acute hypoxemia and COVID-19, prone positioning was not superior to usual care with respect to the rate of endotracheal intubation within 30 days.
Reference
Waleed Alhazzani, Ken Kuljit S Parhar, Jason Weatherald et al. Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2022 Jun 7;327(21):2104-2113.
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