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 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.
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.
Procedure: 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.
Inclusion Criteria:
- 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 Criteria:
- 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).
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
Ken Parhar, MD, MSc
403-944-0735
ken.parhar@ahs.ca
Jason Weatherald, MD
403-943-4779
jcweathe@ucalgary.ca