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Prone Positioning for Patients on General Medical Wards With COVID19

NCT04383613 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-05-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • Sinai Health System

    collaborator OTHER

  • Toronto General Hospital

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • William Osler Health System

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Michael Fralick, MD, PhD · Sinai Health System

  • Fahad Razak, MD, MSc · St. Michael's Hospital (Unity Health Toronto)

  • Amol Verma, MD, MPhil · St. Michael's Hospital (Unity Health Toronto)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383613 on ClinicalTrials.gov