COVID-PRONE is a multicenter, pragmatic, unblinded, 2-arm, parallel, randomized controlled trial seeking to compare the pre-emptive prone positioning (i.e. encouraging patients to adopt a prone position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.
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.
Other: Prone positioning
The intervention is prone positioning (i.e., instructing a patient to lie on their stomach while they are in bed) for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for >24 hours or study outcome. Patients will be asked to aim for prone positioning four times per day for at least two hours each time, and will be encouraged to sleep on their stomach at night.
Inclusion Criteria:
1. Patients ≥ 18 years of age
2. COVID-19 infection is suspected by the treating clinician or confirmed by diagnostic
test
3. Able to lie on their stomach with verbal instruction
4. Requiring supplemental oxygen less than or equal to 50% FiO2
5. Capable to make treatment related decisions
6. Hospitalized in the last 48 hours with suspected or confirmed COVID-19 infection or
diagnosed for nosocomial infection in the last 48 hours during their hospital stay
Exclusion Criteria:
1. Inability to follow commands (e.g., delirium, dementia)
2. indication for mechanical ventilation (e.g., reduced level of consciousness, rapid
clinical deterioration)
3. contraindication to prone positioning (spinal cord injury, unstable c-spine, pelvic
fracture, unstable airway, open chest or abdomen, anterior chest tube, recent
abdominal surgery in past 14 days)
4. patients on home CPAP (continue positive airway pressure)
5. transfer from ICU in past 72 hours
6. need for telemetry at the time of randomization
7. pregnant (i.e., more than 20 weeks)
8. body mass index above 40 kg/m2 (based on clinician's assessment)
9. Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
10. severe hemoptysis
11. pace-maker inserted in past 48 hours
William Osler Health System
Brampton, Ontario, Canada
William Osler Health System
Etobicoke, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada