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

Area of Science:

• Biomedical Engineering
• Medical Devices
• Physiological Monitoring

Background:

• Limited evidence exists on the clinical accuracy of wireless photoplethysmography (PPG) for vital sign monitoring.
• This study addresses the need to evaluate a novel PPG-based earsensor for SpO2, PR, and RR in postoperative patients.

Purpose of the Study:

• To assess the accuracy, technical performance, and patient comfort of a novel wireless PPG earsensor.
• To compare earsensor vital sign measurements against continuous monitoring in a post-anesthesia care unit setting.

Main Methods:

• Observational method comparison study involving 21 postoperative patients.
• Simultaneous recording of SpO2, PR, and RR using the earsensor and standard monitoring.
• Evaluation of bias, 95% limits of agreement (LoA), ARMS, data loss, and patient comfort.

Main Results:

• The earsensor demonstrated accurate measurement of SpO2 (bias 1.7%, ARMS 2.4%) and PR (bias 1.2 bpm, ARMS 3.9 bpm).
• Respiratory rate (RR) accuracy was outside predefined criteria (bias 0.3 brpm, ARMS 4.4 brpm).
• Significant data loss occurred (SpO2 42%, RR 33%, PR 29%), but patient comfort was high (77%).

Conclusions:

• The wireless PPG earsensor shows potential for accurate SpO2 and PR monitoring in postoperative patients.
• While RR accuracy requires improvement, the high patient comfort supports its use for unobtrusive vital sign trend monitoring in low-acuity settings.