COVI-PRONE: Awake prone positioning did not reduce endotracheal intubation vs. usual care
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SAN FRANCISCO — Awake prone positioning did not reduce endotracheal intubation at 30 days compared with usual care in patients with acute hypoxemic respiratory failure from COVID-19, according to results of the COVI-PRONE trial.
At 30 days, 34.1% of patients randomly assigned to awake prone positioning were intubated compared with 40.5% of patients assigned usual care without prone positioning (HR = 0.81; 95% CI, 0.59-1.12; P = .2), Waleed Alhazzani, MD, MSc, associate professor in the department of medicine at McMaster University in Hamilton, Ontario, Canada, said during a presentation at the American Thoracic Society International Conference. The trial was simultaneously published in JAMA.
While the primary outcome result does not support awake prone positioning in this population, “the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit,” the researchers wrote in JAMA.
COVI-PRONE was a pragmatic, unblinded, randomized trial that evaluated efficacy and safety of awake prone positioning in nonintubated adults with acute hypoxemic respiratory failure from COVID-19 who required oxygen ( 40%) or noninvasive ventilation. The trial was conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia and the United States.
Researchers enrolled 400 patients from May 2020 to May 2021. The mean age of patients was 57.6 years and 29% were women.
Those assigned to awake prone positioning had a target duration of 8 to 10 hours per day, with breaks, if needed. Median duration of prone positioning following randomization was 4.8 hours per day.
At 60 days, 22.4% of patients died in the prone positioning group vs. 23.6% in the control group (HR = 0.93; 95% CI, 0.62-1.4; P = .72). The median number of days free from invasive mechanical ventilation was 21.6 vs. 19.6, respectively (P = .11). Results also showed no significant difference in ventilator-free days at 30 days (P = .12), ICU-free days at 60 days (P = .09) or hospital-free days at 60 days (P = .13), the researchers reported.
No serious adverse events occurred. Adverse events occurred in 10% of the awake prone positioning group, most frequently musculoskeletal pain or discomfort (10%) and desaturation (0.98%).
A preplanned subgroup analysis suggested a “possible reduction” in risk for endotracheal intubation in patients with an SpO2 to FiO2 ratio greater than 150 and in those receiving high-flow oxygen. The researchers noted that “it is possible that patients with more severe disease do not benefit from awake prone positioning.”
“It appears that it’s challenging to leave people prone for long hours when they’re awake and not sedated,” Alhazzani said during the presentation. “The effect size was imprecise; however, the subgroup analysis suggests that maybe there are certain subgroups that need to be validated in future studies.”
The researchers also noted the importance of evaluating strategies to enhance adherence to prone positioning, such as verbal support, pain control and mechanical support devices.