A Wireless Photoplethysmography Chest Patch for Continuous Vital Sign Monitoring: A Clinical Validation Study in...

Area of Science:

• Biomedical Engineering
• Critical Care Medicine
• Wearable Technology

Background:

• Continuous vital sign monitoring with wearable biosensors can improve patient safety by enabling earlier detection of clinical deterioration.
• This study focused on a wireless photoplethysmography-based chest patch biosensor designed to measure five vital signs for Early Warning Score calculation.

Purpose of the Study:

• To validate an integrated wireless photoplethysmography-based chest patch biosensor against standard continuous bedside monitoring in an intensive care unit setting.
• To assess the agreement of vital sign measurements between the wearable biosensor and a reference monitor.

Main Methods:

• Bland-Altman analysis was used to assess agreement, calculating bias and limits of agreement for repeated measurements.
• Deming regression, Pearson correlation, and Clarke Error Grid analyses were performed to evaluate measurement differences.
• Data were aligned at 5- and 15-minute intervals using median reference values.

Main Results:

• Heart rate showed a bias of 0.16 bpm with limits of agreement from -17.06 to 17.38.
• Respiratory rate exhibited a bias of 3.77 breaths/min with limits of agreement from -6.78 to 14.31, with over 60% exceeding the 10% threshold.
• Systolic blood pressure, oxygen saturation, and temperature showed biases of -4.69 mmHg, -1.34%, and -0.29°C, respectively.

Conclusions:

• Overall agreement between the wearable chest-patch biosensor and standard bedside monitoring in intensive care patients was variable.
• A substantial proportion of measurements fell outside predefined accuracy thresholds, indicating a need for further optimization.
• Broader clinical application of the wearable biosensor requires further validation and improvement in device performance.