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Published on: December 22, 2016
Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial
Michael Fralick1, Michael Colacci2, Laveena Munshi3
1Division of General Internal Medicine, Sinai Health, Toronto, ON, Canada mike.fralick@mail.utoronto.ca.
Insights
Prone positioning did not improve outcomes for non-critically ill COVID-19 patients needing oxygen. Adherence was low, suggesting future trials should focus on improving patient positioning strategies.
Area of Science:
- Critical Care Medicine
- Respiratory Medicine
- Infectious Diseases
Background:
- COVID-19 can cause hypoxemia requiring supplemental oxygen in non-critical patients.
- Prone positioning is a known intervention to improve oxygenation in severe respiratory distress.
Purpose of the Study:
- To evaluate the effectiveness of prone positioning in reducing death or respiratory failure in hospitalized COVID-19 patients.
- To assess the impact of awake prone positioning on clinical outcomes in non-critically ill COVID-19 patients.
Main Methods:
- A multicenter pragmatic randomized clinical trial involving 257 patients with COVID-19 requiring supplemental oxygen.
- Patients were randomized to either receive instructions for prone positioning or standard care.
- The primary outcome was a composite of in-hospital death, mechanical ventilation, or worsening respiratory failure.
Main Results:
- The trial was stopped early due to futility.
- No significant difference in the primary outcome was observed between the prone positioning group (14%) and the standard care group (14%).
- Adherence to prone positioning was poor, with a median of 6 hours in the prone arm versus 0 hours in the control arm over 72 hours.
Conclusions:
- A multifaceted intervention to increase prone positioning did not improve outcomes in non-critically ill COVID-19 patients with hypoxemia.
- Wide confidence intervals mean benefit or harm cannot be definitively ruled out.
- Future trials should focus on strategies to improve adherence to awake prone positioning.
Objectives:
To assess the effectiveness of prone positioning to reduce the risk of death or respiratory failure in non-critically ill patients admitted to hospital with covid-19.
Design:
Multicentre pragmatic randomised clinical trial.
Setting:
15 hospitals in Canada and the United States from May 2020 until May 2021.
Participants:
Eligible patients had a laboratory confirmed or a clinically highly suspected diagnosis of covid-19, needed supplemental oxygen (up to 50% fraction of inspired oxygen), and were able to independently lie prone with verbal instruction. Of the 570 patients who were assessed for eligibility, 257 were randomised and 248 were included in the analysis.
Intervention:
Patients were randomised 1:1 to prone positioning (that is, instructing a patient to lie on their stomach while they are in bed) or standard of care (that is, no instruction to adopt prone position).
Main Outcome Measures:
The primary outcome was a composite of in-hospital death, mechanical ventilation, or worsening respiratory failure defined as needing at least 60% fraction of inspired oxygen for at least 24 hours. Secondary outcomes included the change in the ratio of oxygen saturation to fraction of inspired oxygen.
Results:
The trial was stopped early on the basis of futility for the pre-specified primary outcome. The median time from hospital admission until randomisation was 1 day, the median age of patients was 56 (interquartile range 45-65) years, 89 (36%) patients were female, and 222 (90%) were receiving oxygen via nasal prongs at the time of randomisation. The median time spent prone in the first 72 hours was 6 (1.5-12.8) hours in total for the prone arm compared with 0 (0-2) hours in the control arm. The risk of the primary outcome was similar between the prone group (18 (14%) events) and the standard care group (17 (14%) events) (odds ratio 0.92, 95% confidence interval 0.44 to 1.92). The change in the ratio of oxygen saturation to fraction of inspired oxygen after 72 hours was similar for patients randomised to prone positioning and standard of care.
Conclusion:
Among non-critically ill patients with hypoxaemia who were admitted to hospital with covid-19, a multifaceted intervention to increase prone positioning did not improve outcomes. However, wide confidence intervals preclude definitively ruling out benefit or harm. Adherence to prone positioning was poor, despite multiple efforts to increase it. Subsequent trials of prone positioning should aim to develop strategies to improve adherence to awake prone positioning.
Study Registration:
ClinicalTrials.gov NCT04383613.
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