Abstract
Accurate assessment of vital parameters is essential for diagnosis and triage of critically ill patients, but not always feasible in out-of-hospital settings due to the lack of suitable devices. We performed an extensive validation of a novel prototype in-ear device, which was proposed for the non-invasive, combined measurement of core body temperature (Tc), oxygen saturation (SpO2), and heart rate (HR) in harsh environments. A pilot study with randomized controlled design was conducted in the terraXcube environmental chamber. Participants were subsequently exposed to three 15 min test sessions at the controlled ambient temperatures of 20 °C, 5 °C, and − 10 °C, in randomized order. Vital parameters measured by the prototype were compared with Tc measurements from commercial esophageal (reference) and tympanic (comparator) probes and SpO2 and HR measurements from a finger pulse-oximeter (reference). Performance was assessed in terms of bias and Lin’s correlation coefficient (CCC) with respect to the reference measurements and analyzed with linear mixed models. Twenty-three participants (12 men, mean (SD) age, 35 (9) years) completed the experimental protocol. The mean Tc bias of the prototype ranged between − 0.39 and − 0.80 °C at ambient temperatures of 20 °C and 5 °C, and it reached − 1.38 °C only after 15 min of exposure to − 10 °C. CCC values ranged between 0.07 and 0.25. SpO2 and HR monitoring was feasible, although malfunctioning was observed in one third of the tests. SpO2 and HR bias did not show any significant dependence on environmental conditions, with values ranging from − 1.71 to − 0.52% for SpO2 and 1.12 bpm to 5.30 bpm for HR. High CCC values between 0.81 and 0.97 were observed for HR in all environmental conditions. This novel prototype device for measuring vital parameters in cold environments demonstrated reliability of Tc measurements and feasibility of SpO2 and HR monitoring. Through non-invasive and accurate monitoring of vital parameters from the ear canal our prototype may offer support in triage and treatment of critically ill patients in harsh out-of-hospital conditions.