The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
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.
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
Other: Standard of Care
Standard temperature management and treatment
Inclusion Criteria:
- 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 Criteria:
- 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.
Sharp Memorial Hospital
San Diego, California, United States