For a study, researchers examined the effectiveness and side effects of prone posture in non-intubated adult patients with acute hypoxemia and COVID-19.
Unblinded, a pragmatic randomized clinical study was undertaken at 21 institutions in Canada, Kuwait, Saudi Arabia, and the United States. Adult patients with COVID-19 who were eligible were not intubated and required oxygen (≥40%) or noninvasive ventilation. Between May 19, 2020, and May 18, 2021, 400 patients were enrolled, with the final follow-up performed in July 2021. Patients were randomly assigned to either awake prone placement (n=205) or normal care without prone positioning (n=195). Endotracheal intubation within 30 days after randomization was the main endpoint. The secondary outcomes were death after 60 days, days free of invasive mechanical ventilation or noninvasive ventilation after 30 days, days free of the intensive care unit or hospital after 60 days, adverse events, and significant adverse events.
The experiment was completed by all (100%) of the 400 randomized patients (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women). The median length of prone positioning in the first four days following randomization was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs. 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone posture group and 79 of 195 patients (40.5%) in the control group had been intubated (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P=.20; absolute difference, 6.37% [95% CI, 15.83% to 3.10%]). Prone positioning did not affect days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or days free from the intensive care unit or hospital at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P=.54; absolute difference, 1.15% [95% CI, 9.40% to 7.10%]). In either group, there were no significant adverse effects. The most frequently reported adverse events in the awake prone positioning group were musculoskeletal pain or discomfort from prone posture (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). In the control group, no adverse events were noted.
In patients with acute hypoxemic respiratory failure caused by COVID-19, prone posture did not substantially reduce endotracheal intubation at 30 days when compared to normal treatment without prone positioning. The impact size for the primary study endpoint, on the other hand, was imprecise and did not rule out a clinically significant advantage.