Continuous BP monitoring of ICU Taiwanese patients: training-phase evaluation of oCare™ BP100 according to ISO 81060-3: 2022

Abstract

Objective This study aimed to conduct a training-phase evaluation of a novel continuous automated non-invasive sphygmomanometer, oCare™ BP100, in intensive care unit (ICU) Taiwanese patients according to ISO 81060-3:2022 in Type T mode. The evaluation included stability testing and blood pressure change tracking. Methods A total of forty ICU patients were recruited from the National Taiwan University Hospital Hsin-Chu Branch. All enrolled patients had undergone unilateral radial artery catheterization in the forearm as part of routine clinical care. The catheter was connected to Philips patient monitors (Models: IntelliVue MX800 and X2) to obtain invasive blood pressure measurements for calibration purposes. Each subject underwent simultaneous monitoring with oCare™ BP100 sensors placed on the fingers of both hands. Paired measurements of the same side were further processed and followed ISO 81060-3:2022, for the defined Type T blood pressure monitor, the well-established stability method and the blood pressure change method were implemented and analyzed. Results The present study belongs to the training phase and therefore the study was not carried out completely according to the ISO 81060-3:2022 protocol, e.g., the distribution of gender and the eligible subject in BP change test not fulfilled. For all 6 analysis periods, for the corrected standard deviations of SBP, DBP, and MAP parameter defined ISO target thresholds (A) scorr ≤ 6 mmHg for each analysis period. In the Blood Pressure Change Test, at most 22 subjects the minimum requirement of 50 change points per subject, the for the change requirements were (B1) E¯50th≤25% and (B2) E¯85th≤50% error for blood pressure. Conclusion The present study demonstrated that a training-phase evaluation of Type T mode continuous automated non-invasive sphygmomanometer repeated SBP, DBP, and MAP measurement of oCare™ BP100 in Type T mode are stable across various analysis periods and patients. oCare™ BP100 in Type T Mode can track blood pressure changes in ICU patients during different activities. Even with the absence of females in the sex ratio and an insufficient number of participants in the blood pressure change test, the exploratory study still showed training-phase results that were within ISO target thresholds, full ISO validation remains to be completed.