CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- ARDS
- COVID-19
- Hypoxemic Respiratory Failure
- Severe Acute Respiratory Syndrome Coronavirus 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective, unblinded, randomized controlled trial at four (4) medical sites in Calgary, Alberta.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients. The objective of this trial is to...
As part of the management of COVID-19 related severe ARDS, the World Health Organization (WHO) recommends prone positioned mechanical ventilation. At this time, it is unclear whether there is a role for prone positioning (PP) of non-mechanically ventilated patients. The objective of this trial is to determine whether PP improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candidates for mechanical ventilation in the ICU. The investigators hypothesize that PP will reduce in-hospital mortality or discharge to hospice, compared with usual care for non-intubated patients with do-not-intubate goals of care with hypoxemic respiratory failure due to probable COVID-19. Patients randomized to the intervention arm will continue with prone positioning until study inclusion criteria are no longer met, discharge from hospital, day 60 in hospital, or until death or discharge to hospice. Daily assessments will occur until day 60 or until the patient is discharged from hospital or is deceased. The investigators anticipate recruitment to be completed within 12 months of starting the trial.
Tracking Information
- NCT #
- NCT04402879
- Collaborators
- Alberta Health Services
- Investigators
- Principal Investigator: Ken Parhar, MD, MSc University of Calgary Principal Investigator: Jason Weatherald, MD University of Calgary
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