Clinical Validation of a Soft Wireless Continuous Blood Pressure Sensor During Surgery

Abstract

We test a new wireless soft capacitance sensor (CAP) based on applanation tonometry at the radial and dorsalis pedis arteries against the gold standard, invasive arterial line (A-Line), for continuous beat to beat blood pressure (BP) measurements in the Operating Room during surgical procedures under anesthesia in 17 subjects with the mean age and body mass index (BMI) of 57. 35 ± 18.72 years and 27.36 ± 4.20 kg/m2, respectively. We have identified several parameters to monitor in order to compare how well the CAP sensor tracks the entire hemodynamic waveform as compared to the A-Line. This includes waveform similarity, heart rate (HR), absolute systolic BP (SBP), diastolic BP (DBP), and temporal response to a vasopressor. Overall, the CAP sensor shows good correlations with A-Line with respect to hemodynamic shape (r > 0.89), HR (mean bias = 0.0006; SD = 0.17), absolute SBP, and DBP in a line of best fit (slope = 0.98 in SBP; 1.08 in DBP) and the mean bias derived from Bland-Altman method to be 1.92 (SD = 12.55) in SBP and 2.38 (SD = 12.19) in DBP across body habitus and age in OR patients under general anesthesia. While we do observe drifts in the system, we still obtain decent correlations with respect to the A-Line as evidenced by excellent linear fit and low mean bias across patients. When we post-process using a different calibration method to account for the drift, the mean bias and SD improve dramatically to −1.85 and 7.19 DBP as well as 1.43 and 7.43 SBP, respectively, indicating a promising potential for improvement when we integrate strategies to account for movement identified by our integrated accelerometer data.