Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation
|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: NCT04494867|
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Device: Core Warming Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Core Warming of COVID-19 Patients Undergoing Mechanical Ventilation: a Randomized, Single Center Pilot Study|
|Actual Study Start Date :||August 19, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Core warming
Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Device: Core Warming
Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
Other Name: EnsoETM
Active Comparator: Standard of Care
Patients receive standard temperature management and treatment
Other: Standard of Care
Standard temperature management and treatment
- PaO2/FiO2 ratio [ Time Frame: 0, 24, 48, and 72 hours after initiation of core warming ]Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
- Viral Load Measurement [ Time Frame: 72 hours after initiation of core warming ]Determine the change in viral load (measured in tracheal aspirate or other appropriate sample as available) after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
- Duration of mechanical ventilation [ Time Frame: 72 hours after initiation of core warming ]Measure the impact of core warming on duration of mechanical ventilation.
- Mortality [ Time Frame: 30 days ]Determine impact of core warming on patient mortality.
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): NCT04494867
|Contact: Katie Miller||(858) 939-7162||Kathryn.Miller@sharp.com|
|United States, California|
|Sharp Memorial Hospital||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Katie Miller 858-939-7162|
|Principal Investigator: David Willms, MD|
|Sub-Investigator: Ahmed Salem, MD|
|Principal Investigator:||David Willms, MD||Sharp HealthCare|
|Principal Investigator:||Ahmed Salem, MD||Sharp HealthCare|