Prone Positioning for Patients on General Medical Wards With COVID19

Unity Health Toronto340 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

340

Conditions

Covid-19 ARDS

Interventions

Prone positioningOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more

Time frame: From date of randomization until the date of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks

Secondary Outcomes

Length of hospitalization

Time frame: Up to 4 weeks [or until hospital discharge]

Adverse events of prone positioning (i.e., venous thromboembolism, pneumonia)

Time frame: Up to 7 days [or until hospital discharge]

In-hospital all-cause mortality

Time frame: From date of randomization until the date of in-hospital all-cause mortality or date of hospital discharge, whichever came first, assessed up to 4 weeks

Invasive or non-invasive mechanical ventilation

Time frame: From date of randomization until the date of invasive or non-invasive mechanical ventilation, or date of hospital discharge, whichever came first, assessed up to 4 weeks

Need for FiO2 of 60% or more

Time frame: From date of randomization until the date of need for FiO2 of 60% or more, or date of hospital discharge, whichever came first, assessed up to 4 weeks

Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more assessed at 30 days, 90 days and 1 year

Time frame: 30 days, 90 days and 1 year after randomization

Time spent in prone positioning among patients achieving the composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more

Data from ClinicalTrials.gov

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