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COVI-PRONE Trial

COVI-PRONE Trial

JAMA

May 15, 2022

Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure.

Mazen Kherallah

Summarized by: 

What was the research question?

  • Does prone positioning reduce the rate of endotracheal intubation in patients with COVID-19 and hypoxemic respiratory failure?


How did they do it?

  • A Pragmatic, unblinded, randomized clinical trial in 21 hospitals in Canada, Saudi Arabia, Kuwait, and the US.

  • 400 patients with COVID-19 infection and hypoxemic respiratory      failure requiring FiO2 ≥40% or non-invasive ventilation but not intubated, were randomized to receive usual care and 8-10 hours/day of awake prone positioning (205 patients) or usual care without prone positioning (195 patients).

  • · The primary outcome measure was endotracheal intubation within 30 days of randomization.


What did they find?

  • Midian duration of prone was 4.8 days in the prone positioning group.

  • Endotracheal intubation within 30 days was not significantly different between the prone positioning group compared to the control group (34.1% vs. 40.5%, P = .20)

  • Secondary outcomes were not different between the prone positioning group and the control group including 60-day mortality (22% vs. 24%, P = .72), days free from invasive mechanical ventilation or noninvasive ventilation at 30 days (21.4 vs. 19.4 days, P=0.12), or days free from the intensive care unit or hospital at 60 days.


Are there any limitations?

  • Unblinded study with potential for bias.

  • Contamination of intervention group as 19% of the control group patients were proned (median of < 1 hour, and 58% required intubation indicating severity of illness).

  • The study has 80% power for 13.5% reduction in rate of intubation, but the effect size was imprecise and cannot exclude a benefit. 95% CI for the absolute difference was −15.83% to 3.10%.

  • Results cannot be generalized to longer duration of prone positioning as the target for the median hours of prone positioning was not achieved.


What does it mean?

  • There was no significant difference between prone positioning and usual care compared to usual care alone in patients with COVID-19 causing acute hypoxemic respiratory failure but not requiring intubation. However, the effect size was imprecise, and a clinically important benefit cannot be excluded.

  • Continue to offer awake prone position in patient with COVID-19 and hypoxemic respiratory failure before intubation.

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