Prone Positioning for Patients on General Medical Wards With COVID19 (COVID-PRONE)

Unity Health Toronto

Status: Unknown

Conditions: Covid-19; ARDS

Treatments: Other: Prone positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT04383613

2020-1

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

PRONE POSITIONING

Experimental group

Description:

Patients in this arm will be instructed 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.

Treatment:

Other: Prone positioning

STANDARD OF CARE

No Intervention group

Description:

Patients in this arm are not specifically instructed to lie on their stomach while they are in bed.