Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 COVID-19 (COVI-PRONE)

Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial

The aim of the COVI-PRONE Trial is to determine if early awake prone positioning in COVID-19 patients with hypoxemic respiratory failure; irrespective of the mode of oxygen delivery; reduces the need for invasive mechanical ventilation.

Inclusion Criteria:

1. Adults ≥ 18 years of age.
2. Suspected or confirmed COVID-19. Defined as: a positive PCR for SARS CoV-2 or pending PCR results for patients that are suspected to have COVID-19.
3. Hypoxemia on room air (SPO2<90%), and oxygen requirement ≥ 0.4 FiO2 (i.e. ≥ 40% oxygen).
4. Bilateral or unilateral chest infiltrates on x-ray as interpreted by the treating team.
5. Admitted to the ICU or an acute care bed where hemodynamic and respiratory monitoring is feasible.

Exclusion Criteria:

1. Immediate need for intubation as determined by the treating team.

2. Decreased level of consciousness (Glasgow Coma Scale score <10), or significant cognitive impairment hat may interfere with compliance (delirium, dementia)

3. Contraindication to proning including, but not limited to any of the following:

   Open chest or abdomen, abdominal surgery (i.e. laparotomy) within the 4 days, Unstable spine, facial, cervical, femur, or pelvic fractures. Limited neck mobility or inability to lie prone comfortably Skeletal deformities that interfere with proning. Complete bowel obstruction. Active upper gastrointestinal bleeding. Patient is unlikely/unable to prone, or to be compliant as indicated by the treating team.

4. Body mass index > 40 kg/m2

5. Pregnancy - third trimester.

6. Patient/substitute decision maker or caring physician's refusal to enroll in the study.

7. Patients with hemodynamic instability and moderate to high dose of vasopressors (norepinephrine dose ≥ 0.15 mcg/kg/min)

8. Intubation is not within patient's goals of care

9. Patient received awake proning session for > 1 day prior to randomization

10. Previous intubation within the same hospital admission