Institute of Mountain Emergency Medicine, Eurac Research, Via Ipazia 2, 39100, Bolzano, Italy.
Laboratory of Biophysics and Translational Cardiology, Department of Cellular, Computational and Integrative Biology-CIBIO, University of Trento, Trento, Italy.
Sci Rep. 2024 Aug 18;14(1):19117. doi: 10.1038/s41598-024-68936-0.
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 (SpO), 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 SpO 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. SpO and HR monitoring was feasible, although malfunctioning was observed in one third of the tests. SpO and HR bias did not show any significant dependence on environmental conditions, with values ranging from - 1.71 to - 0.52% for SpO 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 SpO 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.
准确评估生命参数对于危重病患者的诊断和分诊至关重要，但由于缺乏合适的设备，在院外环境中并不总是可行。我们对一种新型耳内设备进行了广泛验证，该设备旨在用于在恶劣环境中进行非侵入性、核心体温 (Tc)、氧饱和度 (SpO) 和心率 (HR) 的组合测量。一项采用随机对照设计的初步研究在 terraXcube 环境室中进行。随后，参与者在受控环境温度为 20°C、5°C 和 -10°C 的三个 15 分钟测试时段中随机进行。通过原型测量的生命参数与商业食管 (参考) 和鼓室 (比较器) 探头测量的 Tc 以及手指脉搏血氧仪 (参考) 测量的 SpO 和 HR 进行比较。性能评估基于与参考测量的偏差和 Lin 相关系数 (CCC)，并采用线性混合模型进行分析。23 名参与者（12 名男性，平均（标准差）年龄 35（9）岁）完成了实验方案。在环境温度为 20°C 和 5°C 时，原型的平均 Tc 偏差范围在 -0.39 至 -0.80°C 之间，仅在 -10°C 暴露 15 分钟后才达到 -1.38°C。CCC 值范围在 0.07 到 0.25 之间。SpO 和 HR 监测是可行的，尽管在三分之一的测试中观察到了故障。SpO 和 HR 偏差没有表现出任何对环境条件的显著依赖，SpO 的范围为 -1.71% 至 -0.52%，HR 的范围为 1.12bpm 至 5.30bpm。在所有环境条件下，HR 的 CCC 值均在 0.81 到 0.97 之间。这种用于测量寒冷环境中生命参数的新型原型设备证明了 Tc 测量的可靠性以及 SpO 和 HR 监测的可行性。通过从耳道进行非侵入性和准确的生命参数监测，我们的原型设备可为在恶劣的院外环境中对危重病患者进行分诊和治疗提供支持。
