CORONA (COvid pRONe hypoxemiA): Prone Positioning for Hypoxemic COVID-19 Patients With Do-not-intubate Goals
NCT ID: NCT04402879
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
596 participants
INTERVENTIONAL
2020-11-10
2022-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prone Positioning (PP)
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day.
Prone Positioning (PP)
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge.
The target duration (dose) of PP is \> 8 hours per day for up to 60 days, or until oxygen requirements are \< 2 L per minute or \< 2 L per minute above baseline home oxygen requirements.
Control - usual management
The control group will consist of standard medical care with no instructions or prompts to change positioning to staff or patients.
No interventions assigned to this group
Interventions
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Prone Positioning (PP)
The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge.
The target duration (dose) of PP is \> 8 hours per day for up to 60 days, or until oxygen requirements are \< 2 L per minute or \< 2 L per minute above baseline home oxygen requirements.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
No
Sponsors
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Alberta Health services
OTHER
University of Calgary
OTHER
Responsible Party
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Ken Kuljit Parhar, MD
Consultant Intensivist & Clinical Assistant Professor
Principal Investigators
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Ken Parhar, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Jason Weatherald, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Peter Lougheed Centre (PLC)
Calgary, Alberta, Canada
Foothills Hospital Intensive Care Unit
Calgary, Alberta, Canada
Rockyview General Hospital
Calgary, Alberta, Canada
South Health Campus
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Jason Weatherald, MD
Role: primary
Ken Parhar, MD, MSc
Role: primary
Kevin Solverson, MD
Role: primary
Henry T Stelfox, MD PhD
Role: primary
References
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Weatherald J, Norrie J, Parhar KKS. Awake prone positioning in COVID-19: is tummy time ready for prime time? Lancet Respir Med. 2021 Dec;9(12):1347-1349. doi: 10.1016/S2213-2600(21)00368-4. Epub 2021 Aug 20. No abstract available.
Other Identifiers
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REB20-0518
Identifier Type: -
Identifier Source: org_study_id