Dr. Melissa I Naiman, a healthcare technology adoption and evaluation researcher at the University of Illinois at Chicago, aggregated data from three clinical sites to assess real-world performance of the ensoETM.

Study Abstract:

Core temperature management is an important aspect of critical care; preventing unintentional hypothermia, reducing fever, and inducing therapeutic hypothermia when appropriate are each tied to positive health outcomes. The purpose of this study is to evaluate the performance of a new temperature management device that uses the esophageal environment to conduct heat transfer. De-identified patient data were aggregated from three clinical sites where an esophageal heat transfer device (EHTD) was used to provide temperature management. The device was evaluated against temperature management guidelines and best practice recommendations, including performance during induction, maintenance, and cessation of therapy. Across all active cooling protocols, the average time-to-target was 2.37 h and the average maintenance phase was 22.4 h. Patients spent 94.9% of the maintenance phase within ±1.0°C and 67.2% within ±0.5°C (574 and 407 measurements, respectively, out of 605 total). For warming protocols, all of the patient temperature readings remained above 36°C throughout the surgical procedure (average 4.66 h). The esophageal heat transfer device met performance expectations across a range of temperature management applications in intensive care and burn units. Patients met and maintained temperature goals without any reported adverse events.