Clinical Validation of Moni-Patch TM for Perioperative Core Temperature Monitoring: A Prospective Observational Study Comparing with Esophageal Temperature Measurements

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Abstract

Purpose Maintaining normothermia during surgery is essential for reducing perioperative complications. Although esophageal temperature monitoring is considered the gold standard for intraoperative core temperature assessment, it is invasive. Moni-Patch TM is a novel, noninvasive, wireless skin-surface sensor designed to estimate core temperature by measuring over the carotid artery. This study aimed to evaluate the clinical agreement between Moni-Patch TM , a novel noninvasive wireless temperature sensor, and esophageal temperature measurements during general anesthesia. Methods We conducted a prospective observational study in 40 adult patients undergoing non-cardiac surgery under general anesthesia lasting ≥120 minutes. Temperature measurements were recorded at one-minute intervals using both devices. Agreement was assessed using Bland-Altman analysis with random-effects modeling and Lin's concordance correlation coefficient (CCC). The proportion of measurements within ±0.5 °C of the reference value was calculated. Sensitivity and specificity for detecting hypothermia and hyperthermia were also evaluated. Results A total of 12,320 paired measurements were analyzed. Bland-Altman analysis demonstrated a small mean bias of 0.063 °C. The 95% limits of agreement ranged from -0.59 °C to 0.71 °C. Lin’s CCC was 0.90 (95% CI, 0.897-0.904). Overall, 88.8% of measurements were within ±0.5 °C of the esophageal reference. Moni-Patch demonstrated high sensitivity and specificity for detecting both hypothermia and hyperthermia. No device-related adverse events were observed. Conclusion Moni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a reliable noninvasive alternative for intraoperative core temperature monitoring. UMIN Clinical Trials Registry ID: UMIN000038589

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