Materials and Methods
HEAT, ACUTE RESPIRATORY DISTRESS SYNDROME, GROUP B
This was a single-center randomized controlled pilot trial (NCT04494867), and we have previously published the study protocol (Bonfanti et al., Once the randomization form was entered into the system and saved, the back-end algorithm ran and participants were assigned an arm corresponding to either study device (Group A—Core warming) or standard of care (Group B—Control). Patients underwent randomization after being enrolled into the study and before the placement of the core warming device. Randomization was performed in a 1:1 manner and maintained on the limited access, encrypted, Redcap database. All procedures followed were in accordance with the ethical standards of the Sharp Memorial Hospital IRB (IRB No. 2007901; approved August 17, 2020) and with the Helsinki Declaration of 1975.The primary outcome was the severity of acute respiratory distress syndrome as measured by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ratio. Secondary outcomes included the change in viral load measured in lower respiratory tract samples, the duration of mechanical ventilation, and mortality. Patient core warming was provided by a commercially available esophageal heat exchange system (ensoETM; Attune Medical). The device was set to 42°C after initiation and maintained at 42°C for the duration of 72 hours of treatment unless patient temperature exceeded 39.8°C, at which point the device setpoint was reduced to 40°C. Control patients were provided standard temperature management.