Status:
WITHDRAWN
Core Warming of COVID-19 Patients
Lead Sponsor:
Washington University School of Medicine
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater ...
Detailed Description
Participants will be randomized in a 1:1 fashion to core warming with the study device (ensoETM) or to standard of care (standard temperature management and treatment). The device will be used as indi...
Eligibility Criteria
Inclusion
- Patients above the age of 18 years old.
- Patients with a diagnosis of COVID-19 on mechanical ventilation.
- Patient maximum baseline temperature (within previous 12 hours) \< 38.3°C.
- Patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form.
Exclusion
- Patients without surrogate or legally authorized representative able to provide informed consent.
- Patients with contraindication to core warming using an esophageal core warming device.
- Patients known to be pregnant.
- Patients with \<40 kg of body mass.
- Patients with DNR status.
- Patients with acute stroke, post-cardiac arrest, or multiple sclerosis.
- Patients with history of esophageal disease
- Patients with a baseline epinephrine dose greater than 0.6 mcg/kg/min
- Patients with atrial fibrillation, atrial flutter, or other multifocal atrial tachycardia with a heart rate greater than 110 beats per minute.
- Patients on 0.2 mcg/kg/min or more of norepinephrine
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04426344
Start Date
October 1 2020
End Date
December 1 2020
Last Update
October 19 2020
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110