Status:
UNKNOWN
Prone Positioning for Patients on General Medical Wards With COVID19
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Sinai Health System
Conditions:
Covid-19
ARDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 positi...
Detailed 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 pat...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age
- COVID-19 infection is suspected by the treating clinician or confirmed by diagnostic test
- Able to lie on their stomach with verbal instruction
- Requiring supplemental oxygen less than or equal to 50% FiO2
- Capable to make treatment related decisions
- 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
- Inability to follow commands (e.g., delirium, dementia)
- indication for mechanical ventilation (e.g., reduced level of consciousness, rapid clinical deterioration)
- 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)
- patients on home CPAP (continue positive airway pressure)
- transfer from ICU in past 72 hours
- need for telemetry at the time of randomization
- pregnant (i.e., more than 20 weeks)
- body mass index above 40 kg/m2 (based on clinician's assessment)
- Recently completed or plan for intrathoracic or intra-abdominal surgical procedure
- severe hemoptysis
- pace-maker inserted in past 48 hours
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT04383613
Start Date
May 15 2020
End Date
June 1 2021
Last Update
May 13 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
William Osler Health System
Brampton, Ontario, Canada
2
William Osler Health System
Etobicoke, Ontario, Canada
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8