Clinical performance evaluation of a cuffless continuous non-invasive blood pressure monitoring device in ICU patients

Purpose To evaluate the accuracy, stability, and dynamic BP tracking capability of a cuffless continuous non-invasive blood pressure (CNIBP) wearable system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) to track dynamic blood pressure (BP) changes in intensive care unit (ICU) patients. Methods A multicenter, prospective clinical trial enrolled ICU patients aged ≥ 12 years who required continuous invasive blood pressure (IBP) monitoring for ≥ 24 h. The mWear wearable monitoring system (Mindray) served as the test device, with IBP as the reference standard. The study followed the International Organization for Standardization (ISO) 81060-3:2022 guidelines to evaluate the accuracy, stability, and dynamic BP tracking. Results Forty-nine participants (mean age, 57.3 ± 18.7 years) were included in the study. The mean differences between CNIBP and IBP measurements for systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were -0.31 mmHg, -0.81 mmHg, and -0.37 mmHg, respectively, all within the predefined 95% confidence interval (CI). The corrected experimental standard deviations (SD) were 5.3, 3.6, and 3.6 mmHg, respectively, consistent with the ISO 81060-3:2022 criteria (mean difference: -6 to 6 mmHg; corrected experimental SD: ≤10 mmHg). The Pearson correlation coefficient (PCC) exceeded 0.9, indicating a strong linear correlation. Stability assessments demonstrated that CNIBP remained within ISO error ranges over 24 h. For BP change-tracking ability, the median absolute error (E percent , 50th percentile) averaged ≤25%, and the 85th percentile averaged ≤50%, both of which met ISO requirements. Conclusion The findings indicate that CNIBP device measurements are consistent with IBP readings in terms of accuracy, stability, and dynamic BP tracking capability within the ICU. This consistency effectively supports real-time hemodynamic assessment in critically ill patients.