NEW YORK (Reuters Health) - Results of the COVI-PRONE trial do not support prone positioning for awake non-intubated COVID-19 patients with acute respiratory distress.
However, the effect size for the primary outcome (intubation) was "imprecise and does not exclude a clinically important benefit," the study team says in JAMA.
The COVI-PRONE trial enrolled 400 adult COVID patients who were not intubated and who required oxygen (≥ 40%) or noninvasive ventilation; 205 were randomly allocated to awake prone positioning and 195 to usual care without prone positioning.
Endotracheal intubation within 30 days of randomization (the primary outcome) occurred in fewer patients in the prone positioning group (34.1% vs 40.5%), but the difference was not statistically significant (hazard ratio, 0.81; 95% CI, 0.59 to 1.12).
Several small trials have assessed awake prone positioning in patients with COVID-19 but none have shown a reduction in endotracheal intubation or death, Dr. Waleed Alhazzani, with McMaster University in Hamilton, Canada, and colleagues note in their paper.
The preplanned subgroup analysis of COVI-PRONE showed a possible reduction in risk for intubation with prone positioning in patients with oxygen saturation to fraction of inspired oxygen ratio (SpO2:FIO2) >150 and in those receiving high-flow oxygen.
"It is possible that patients with more severe disease do not benefit from awake prone positioning. However, the false discovery rate did not reach statistical significance for any of the preplanned subgroups, therefore, these findings should be interpreted with great caution and considered hypothesis generating," the researchers say.
There were 26 adverse events reported in the trial, most (62%) of which were related to pain and discomfort from prone positioning, in line with findings from other trials.
"Long hours of awake prone positioning are challenging and highly influenced by patient comfort and preference in contrast to prone positioning of sedated (and often pharmacologically paralyzed) patients requiring invasive mechanical ventilation," the researchers say.
The median duration of prone positioning per day was roughly five hours. While this was longer than in most published studies, the target of eight to 10 hours per day was not universally achieved.
"The most common reason for interruption of prone positioning was patient request, which might have been related to overall subjective improvement or related to discomfort from prone positioning," Dr. Alhazzani and colleagues report.
"Given the pragmatic design of this trial, these findings reflect the challenges with implementing prone positioning in awake patients with severe illness," they add.
SOURCE: https://bit.ly/39ZzrJ3 JAMA, online May 15, 2022.
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