Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial (COVI-PRONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04350723|
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection Covid19||Procedure: Awake Proning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A multicenter, parallel-group randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||August 30, 2021|
Experimental: Intervention - 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.
Procedure: Awake Proning
The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
No Intervention: Control - Standard of Care
The patient will receive usual care without proning at the discretion of the treating team.
The oxygen mask or NIPPV or HFNC will be initiated, the choice of starting oxygen mask versus NIPPV versus HFNC will be up to the treating team, the patient will be observed for 15 minutes to ensure that: SPO2 > 90% and the patient is tolerating NIPPV or HFNC treatment.
- Endotracheal intubation [ Time Frame: within 30 days of randomization ]Medical procedure in which a tube is placed into the windpipe (trachea) through the mouth.
- Mortality [ Time Frame: 60 days ]Death
- Invasive mechanical ventilation free days [ Time Frame: 30 Days ]Number of days not receiving mechanical ventilation
- Non-invasive ventilation free days [ Time Frame: 30 days ]Number of days not receiving non-invasive mechanical ventilation
- ICU length of stay [ Time Frame: 30 Days ]Number of days admitted to ICU
- Hospital length of stay [ Time Frame: 30 days ]Number of days admitted to the hospital
- Change in oxygenation [ Time Frame: 30 days ]defined as the difference in SpO2: FiO2 ratio. The difference in SpO2: FiO2 ratio.
- Complications from proning, [ Time Frame: 30 days ]Includes any of the following: accidental removal of intravenous access, vomiting, falls from bed, pressure injuries, or cardiac arrest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350723
|Contact: Sarah Culgin||905-522-1155 ext firstname.lastname@example.org|
|Contact: Zainab Al Duhalibemail@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Waleed Alhazzani firstname.lastname@example.org|
|Contact: Sarah Culgin email@example.com|
|Sub-Investigator: Dan Perri, MD|
|Hamilton General Hospital||Not yet recruiting|
|Contact: Lori Hand|
|Principal Investigator: Maureen Meade|
|Juravinski Hospital||Not yet recruiting|
|Contact: Tina Millen|
|Principal Investigator: Bram Rochwerg|
|St. Catharine's General -||Not yet recruiting|
|St. Catharines, Canada|
|Contact: Lisa Patterson|
|Principal Investigator: Erick Duan|
|Sub-Investigator: Jenn Tsang|
|King Fahad Hospital of the University||Recruiting|
|Khobar, Eastern Province, Saudi Arabia|
|Contact: Mohammed Alshahrani, MD|
|Sub-Investigator: Yousef Almubarak, MD|
|Principal Investigator: Mohammed Alshahrani, MD|
|King Faisal Specialist Hospital & Research Center||Recruiting|
|Riyadh, Saudi Arabia|
|Contact: Sheryl Abdukahil|
|Principal Investigator: Yaseen Arabi|
|Principal Investigator:||Waleed Alhazzani||St. Joseph's Healthcare Hamilton|
|Principal Investigator:||Yaseen Arabi||King Saud Bin Abdulaziz University for Health Sciences|
|Principal Investigator:||Zainab Alduhailib||King Faisal Specialist Hospital and Research Center, Jeddah|