1. This randomized clinical trial demonstrated no difference in the risk of endotracheal intubation requirement at 30 days between awake prone positioning and standard positioning for patients with COVID-19 who suffered from acute hypoxemic respiratory failure.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Prone positioning has been shown to reduce the risk of mortality in patients undergoing invasive mechanical ventilation for acute respiratory distress. Given the concern of limited resources during the COVID-19 pandemic, awake prone positioning has been attempted as an intervention for non-intubated patients with respiratory failure. However, the evidence is mixed regarding whether prone positioning reduces endotracheal intubation requirements in COVID-19 patients with respiratory distress. The COVI-PRONE unblinded, randomized clinical trial examined whether awake prone positioning in COVID-19 patients with hypoxemic respiratory failure reduced the risk of endotracheal requirement and mortality. This study was conducted at 21 hospitals and included adults who required at least 40% oxygen or non-invasive positive pressure ventilation and had not received invasive mechanical ventilation. Four hundred patients were randomized to either the intervention group (205 participants; prone position 8-10 hours per day) or the control group (195 participants; no prone positioning). The primary outcome was endotracheal intubation within 30 days of randomization. The risk of endotracheal intubation did not significantly differ between groups at 30 days (prone group: 34.1%, control group: 40.5%; absolute difference: -6.37% [95% CI: -15.83 to 3.1]; HR: 0.81 [95%: 0.59-1.12]). Similarly, the risk of mortality at 60 days was similar between groups (HR: 0.93 [95% CI: 0.62-1.40]). Despite no serious adverse events in both groups, the prone positioning group reported more overall adverse events (26 vs. 0), mainly consisting of pain or discomfort laying in the prone position. Of note, there were no differences in the use of pharmacological agents, such as steroids, antivirals, anticoagulants, or immunomodulators between cohorts. Overall, this trial demonstrated that prone positioning did not decrease the risk of endotracheal intubation or mortality in patients with acute hypoxemic respiratory failure due to COVID-19. One limitation of this study is, however, that the effect size was imprecise as the confidence interval consisted of a large interval range.
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