A wearable cuffless blood pressure monitoring system: real-time measurement using force sensing and waveform analysis

This paper introduces a wearable, cuffless blood pressure (BP) monitoring system for continuous, real-time measurement in the operating room. Traditional cuff-based BP monitoring is intermittent and unsuitable for surgery, while intra-arterial measurements are invasive. The system uses a finger clip with a force sensor to detect pressure changes caused by arterial pulsations, with a waveform decomposition analysis algorithm estimating systolic and diastolic BP in real time. A clinical validation study involving 46 patients in the operating room demonstrated the system's accuracy, with reference measurements from an intra-arterial catheter. The reference systolic pressure ranged from 83 mmHg to 194 mmHg, and diastolic pressure from 42 mmHg to 105 mmHg. The error between paired measurements was - 1.44 ± 6.64 mmHg for systolic and 3.35 ± 6.91 mmHg for diastolic, with the device's measurements meeting the ISO 81060-2:2018 accuracy specification of 5 ± 8 mmHg. Pearson correlation coefficients were r = 0.90 (p < 0.01) for systolic and r = 0.78 (p < 0.01) for diastolic, indicating significant correlations with intra-arterial catheter measurements. The data analysis also considered the IEEE 1708 standard, ensuring compliance with guidelines for non-invasive BP monitoring. In collaboration with the device developer, the authors designed the clinical calibration protocol and user interface to ensure compatibility with intra-operative monitoring workflows. This study represents the first clinical validation of a tactile force-sensing cuffless system against intra-arterial reference measurements, demonstrating its feasibility for real-time, non-invasive blood pressure monitoring during anesthesia.