PROJECT HIGHLIGHTS
Governance Organization
SMH – St. Michael’s Hospital Medical Services Association
Project Title
SMH-21-005 – Prone positioning for patients on general medical wards with COVID-19: A multicenter pragmatic randomized trial [COVID-PRONE]
Project Highlights
Prone positioning has been part of clinical practice since the 1970s and is considered standard of care for mechanically ventilated patients who have severe acute respiratory distress syndrome. Early in the COVID-19 pandemic, uncontrolled studies suggested prone positioning may reduce the risk of respiratory failure and death among non-intubated patients with severe hypoxia; however, without data from randomized clinical trials, it was impossible to definitively know whether this is the case.
In this unblinded pragmatic randomized clinical trial conducted in 15 hospitals in Canada and the United States, we assessed the efficacy of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients hospitalized with COVID-19 (NCT04383613). Among 248 patients randomized, we found no improvements in the risk of the composite of death, mechanical ventilation, or worsening respiratory failure. Further, we did not observe improvements in oxygenation. Overall, adherence to prone positioning was low (the median total time spent in prone position in the first 72 hours was 6 hours (interquartile range [IQR] 1.5,12.8) for the prone arm), despite inclusion and exclusion criteria identifying patients most likely to be able to prone and multiple efforts to encourage prone positioning. The trial was stopped early based on the futility of finding the pre-specified effect size. The poor adherence to prone positioning we observed highlights that it is generally not well tolerated and innovative approaches are needed to improve adherence. Subsequent trials of prone positioning would benefit from considering patients at potential highest likelihood for benefit, and developing strategies that allow greater tolerability and adherence to prone positioning.
Theme
Prevention and Treatment
Primary Project Lead for Contact
Dr. Amol Verma
Secondary Project Lead for Contact
Dr. Fahad Razak