Prone Positioning for Patients on General Medical Wards With COVID19

NCT ID: NCT04383613

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-06-01

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

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 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.

Conditions

Covid-19; ARDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PRONE POSITIONING

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.

Group Type: EXPERIMENTAL

Prone positioning

Intervention Type: OTHER

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.

STANDARD OF CARE

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Sinai Health System

OTHER

Sponsor Role: collaborator

Toronto General Hospital

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

William Osler Health System

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fralick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Fahad Razak, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital (Unity Health Toronto)

Amol Verma, MD, MPhil

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital (Unity Health Toronto)

Locations

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

Countries

Canada

References

Fralick M, Colacci M, Munshi L, Venus K, Fidler L, Hussein H, Britto K, Fowler R, da Costa BR, Dhalla I, Dunbar-Yaffe R, Branfield Day L, MacMillan TE, Zipursky J, Carpenter T, Tang T, Cooke A, Hensel R, Bregger M, Gordon A, Worndl E, Go S, Mandelzweig K, Castellucci LA, Tamming D, Razak F, Verma AA; COVID Prone Study Investigators. Prone positioning of patients with moderate hypoxaemia due to covid-19: multicentre pragmatic randomised trial (COVID-PRONE). BMJ. 2022 Mar 23;376:e068585. doi: 10.1136/bmj-2021-068585.

Reference Type: DERIVED

PMID: 35321918 (View on PubMed)

Other Identifiers

2020-1

Identifier Type: -

Identifier Source: org_study_id