Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation: protocol for a randomized controlled pilot study

Nathaniel Bonfanti; Emily Gundert; Kristina Goff; Anne Drewry; Roger Bedimo; Erik Kulstad

Participants who have a signed research study consent form (via surrogate or legally authorized representative) will be randomized in a 1:1 fashion to core warming or to standard of care (standard temperature management and treatment). The esophageal heat transfer device will be used according to FDA 510(k) labeling (for patient warming). Patient temperature measurements will be collected for both the device and standard-of-care arms during the study period (up to 72 hours). Device placement will be performed using standard protocol per instructions for use. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. All patients will have usual standard of care labs, vital signs, and imaging for patients in critical condition undergoing mechanical ventilation in the ICU. Specific parameters to be measured include PaO2 at regular intervals appropriate for patients undergoing mechanical ventilation, and FiO2 at the time of obtaining blood gases for PaO2 measurement, to allow calculation of P/F ratio.