Continuous Vital Signs Monitoring with a Wireless and Wearable Earsensor in Surgical Patients: A Clinical Validation Study

Abstract

(1) Background: Evidence on the clinical accuracy of wireless photoplethysmography (PPG)-based vital sign monitoring is limited. This study evaluated the accuracy, technical performance, and patient comfort of a novel PPG-based earsensor for measuring oxygen saturation (SpO2), pulse rate (PR), and respiratory rate (RR) in postoperative patients. (2) Methods: In this observational method comparison study, SpO2, PR, and RR were simultaneously recorded using the earsensor and compared with continuous monitoring in patients admitted overnight to the post-anesthesia care unit. Outcome measures were bias, 95% limits of agreement (LoA), and average root mean square (ARMS). Technical performance was evaluated by data loss and data gap duration. Patient comfort was assessed using a questionnaire. (3) Results: Twenty-one patients contributed to 264 h of data. Bias was 1.7% for SpO2 (ARMS 2.4%; LoA −1.8% to 5.1%), 1.2 bpm for PR (ARMS 3.9 bpm; LoA –6.1 to 8.4 bpm), and 0.3 brpm for RR (ARMS 4.4 brpm; LoA –8.4 to 8.9 brpm). Overall, data loss was 42% for SpO2, 33% for RR, and 29% for PR; most data gaps were under 30 min. Patient-reported comfort was high (77%). (4) Conclusions: The earsensor accurately measured SpO2 and PR. RR accuracy was outside the predefined criteria. Despite substantial data loss, patient comfort was high, supporting the potential of PPG-based sensors for unobtrusive vital sign trend monitoring in low-acuity settings.