Prone Positioning for Patients on General Medical Wards With COVID19
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 350
Summary
- Conditions
- ARDS
- COVID-19
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial.Masking: None (Open Label)Masking Description: The study will be unblindedPrimary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial. The intervention is not a medication or a medical device. Instead, the intervention is instructing patients to lie on their stomach while they are in bed. Patients will be randomized to receive either s...
COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial. The intervention is not a medication or a medical device. Instead, the intervention is instructing patients to lie on their stomach while they are in bed. Patients will be randomized to receive either standard-of-care or pre-emptive prone positioning while in bed plus standard of care. Randomization will be stratified by site. Patients randomized to prone positioning will be instructed to i) lie on their stomach supported by their arms and a pillow at the level of their shoulders and another pillow at the level of the pelvis, ii) immediately thereafter their oxygen saturation will be checked, iii) after a two hour period they can reposition to supine (but should be educated on the use of prone position and encouraged to adopt prone position as often as tolerated while in bed); the 2-hour period will be encouraged four times each day in addition to during sleep overnight. Since there are limited data on the potential risks and benefits of prone positioning, a feasibility analysis will be performed after 30 patients are randomized to identify the rate of serious adverse events in the prone group (e.g., rate of pneumonia, death, intubation) and to understand the change in oxygenation as a result of prone positioning.
Tracking Information
- NCT #
- NCT04383613
- Collaborators
- Sunnybrook Health Sciences Centre
- Sinai Health System
- Toronto General Hospital
- University Health Network, Toronto
- William Osler Health System
- Investigators
- Principal Investigator: Michael Fralick, MD, PhD Sinai Health System Principal Investigator: Fahad Razak, MD, MSc St. Michael's Hospital (Unity Health Toronto) Principal Investigator: Amol Verma, MD, MPhil St. Michael's Hospital (Unity Health Toronto)