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

Not Applicable

Completed

• Conditions: Corona Virus Infection; Covid19; COVID-19
• Interventions: Procedure: Awake Proning

• Registration Number: NCT04350723
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-17
• Study Start: 2020-06-10
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - Awake Proning	Awake Proning	The oxygen mask or NIPPV or HFNC will be initiated at the treating team's discretion. The patient will be observed for 15 minutes to ensure that: SPO2 \> 90% and the patient is tolerating oxygen mask or NIPPV or HFNC treatment. Once the patient achieves the above parameters within 15 minutes of initiating oxygen therapy through any modality, the healthcare team will start awake proning.

Primary Outcome Measures

Name	Time	Method
Endotracheal intubation	within 30 days of randomization	Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.

Secondary Outcome Measures

Name	Time	Method
Mortality	60 days	Death
Days alive and outside of hospital	60 days	Number of days alive and outside of hospital
Complications from proning,	30 days	Includes any of the following: accidental removal of intravenous access, hypotension, pressure injuries, or other.
Invasive mechanical ventilation free days	censored at 30 Days	Number of days not receiving mechanical ventilation
Days alive and outside ICU	60 Days	Number of days alive and outside the ICU
Non-invasive ventilation free days	censored 30 days	Number of days not receiving non-invasive mechanical ventilation

Trial Locations

Locations (17)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

University of Texas Health Sciences Centre; 🇺🇸 Dallas, Texas, United States

St. Catharine's General -; 🇨🇦 St. Catharines, Ontario, Canada

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Sinai Health System; 🇨🇦 Toronto, Ontario, Canada

CHU de Québec - Université Laval; 🇨🇦 Quebec, Canada

Jaber Al Ahmed hospital; 🇰🇼 Kuwait, Kuwait

Prince Mohammed bin Abdulaziz Hospital; 🇸🇦 Al Madīnah, Saudi Arabia

King Abdulaziz Medical City - Jeddah; 🇸🇦 Jeddah, Saudi Arabia

King Abdulaziz Hospital - NGHA; 🇸🇦 AlAhsa, Saudi Arabia

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Saudi Arabia

King Fahad Hospital of the University; 🇸🇦 Khobar, Eastern Province, Saudi Arabia

Al-Amir Hospital; 🇰🇼 Kuwait, Kuwait

Univeristy of Calgary; 🇨🇦 Calgary, Alberta, Canada

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada