Core Warming of COVID-19 Patients

Withdrawn before enrolling · Not applicable

Conditions studied: COVID 19

In brief

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 overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.

Key facts

Study ID

NCT04426344

Run by

Washington University School of Medicine

People needed

0

Starts

2020-10-01

Expected to finish

2020-12-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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