Status:
UNKNOWN
CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Alberta Health services
Conditions:
Severe Acute Respiratory Syndrome Coronavirus 2
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to determine whether Prone Positioning (PP) improves outcomes for non-intubated hospitalized patients with hypoxemic respiratory failure due to COVID-19, who are not candi...
Detailed 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 f...
Eligibility Criteria
Inclusion
- Hospitalized patients with probable COVID-19. Probable is defined as Influenza like illness (ILI) symptoms OR confirmed COVID-19 exposure AND COVID-19 testing performed. ILI is defined as any one of the following symptoms including: fever, new or worsening cough, coryza, new or worsening dyspnea, or sore throat.
- Goals of care are do-not-intubate (R3 or M1/M2 in Alberta).
- Need for oxygen ≥2 L to maintain SpO2 ≥92%. If the patient is on long-term oxygen, the O2 requirements must be ≥2 L above their baseline.
- Patient can be positioned to and from prone to supine with minimal assistance (maximum one person assistance).
Exclusion
- Decreased level of consciousness (Glasgow Coma Scale \< 10) or precluding ability to self-reposition.
- Hemodynamic instability (Systolic Blood Pressure \< 90 mmHg and or Lactate \>5 mmol/L or HR \>120, not responsive to fluid resuscitation).
- Complete bowel obstruction.
- Active upper gastrointestinal bleeding.
- Poor neck mobility or patient inability to lie prone comfortably.
- Unstable spine, femur, or pelvic fractures.
- Pregnancy - third trimester.
- Full resuscitation status including ICU and willingness to accept invasive mechanical ventilation (i.e. R1/R2 goals of care).
- Imminent palliation or end of life expected on admission (i.e. C1/C2 goals of care).
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT04402879
Start Date
November 10 2020
End Date
June 1 2022
Last Update
December 17 2020
Active Locations (4)
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1
Peter Lougheed Centre (PLC)
Calgary, Alberta, Canada, T1Y 6J4
2
Foothills Hospital Intensive Care Unit
Calgary, Alberta, Canada, T2N 2T9
3
Rockyview General Hospital
Calgary, Alberta, Canada, T2V 1P9
4
South Health Campus
Calgary, Alberta, Canada, T3M 1M4