Awake Prone Position in Hypoxemic Patients With Coronavirus Disease 19 (COVI-PRONE): A Randomized Clinical Trial (COVI-PRONE)
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|ClinicalTrials.gov Identifier: NCT04350723|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection||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|
|Estimated Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 31, 2020|
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: 30 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|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Waleed Alhazzani||St. Joseph's Healthcare Hamilton|