Prone Positioning for Patients on General Medical Wards With COVID19

Covid-19 Clinical Trial

— COVID-PRONE  

Official title:

Prone Positioning for Patients on General Medical Wards With COVID19: A Multicenter Pragmatic Randomized Trial [COVID-PRONE]

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04383613
• Other study ID #: 2020-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 position before they require mechanical ventilation) to the control arm of standard care alone. Randomization will be stratified by site.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 340
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• Covid-19

Intervention

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.

Locations

Country	Name	City	State
Canada	William Osler Health System	Brampton	Ontario
Canada	William Osler Health System	Etobicoke	Ontario
Canada	Sinai Health System	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
Unity Health Toronto	Sinai Health System, Sunnybrook Health Sciences Centre, Toronto General Hospital, University Health Network, Toronto, William Osler Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility outcome: Change in oxygen saturation before and after prone positioning (to be measured for 72 hours beginning at the time of randomization), which will be calculated as:	I) The ratio between the patient's oxygen saturation and the amount of oxygen they're inspiring, II) Sustained (i.e., more than 5 minutes) drop in oxygen saturation less than 88% in the prone position on the same oxygen therapy required to maintain a saturation of >92% in the supine position.	72 hours
Other	Feasibility outcome: Rate or serious adverse events	Rate of serious adverse events as identified through routine care by the patient's attending physician (e.g., venous thromboembolism, pneumonia) or through objective testing (i.e., death, transfer to the intensive care unit). Notably, bacterial pneumonia will be pragmatically defined through the combination of a chest x-ray report identifying evidence of pneumonia and the receipt of antibiotics known to treat pneumonia	Up to 7 days
Other	Feasibility outcome: Adherence to prone positioning	The patients will be called on day 3 and 7. The research assistant/coordinator will ask the patient to estimate the number of hours spent in prone position.	Day 3 and day 7
Primary	Composite outcome of in-hospital all-cause mortality, invasive or non-invasive mechanical ventilation, or need for FiO2 of 60% or more		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	Length of hospitalization		Up to 4 weeks [or until hospital discharge]
Secondary	Adverse events of prone positioning (i.e., venous thromboembolism, pneumonia)		Up to 7 days [or until hospital discharge]
Secondary	In-hospital all-cause mortality		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
Secondary	Invasive or non-invasive mechanical ventilation		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
Secondary	Need for FiO2 of 60% or more		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
Secondary	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		30 days, 90 days and 1 year after randomization
Secondary	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		Up to 7 days