NCT06815614

This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022

A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer: Performance Evaluation in Stability and Blood Pressure Change Tracking

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Taiwan Biophotonic Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP100 start-to-end blood pressure calibration. The invasive arterial catheter (A-line) blood pressure measurement will be used as a reference invasive blood pressure monitor (BPM) equipment. The purpose of the study is to evaluate the stability of the device under evaluation (DUE) and its performance in blood pressure change tracking.

Detailed description

1. The primary goal (Stability Test): to validate the stability of the repeated measurements of DUE, and the corrected standard deviation of each analysis period shall not exceed 6 mmHg. 2. The secondary goal (Blood Pressure Change Tracking): to validate the consistency of DUE vs. the reference BPM equipment in blood pressure change tracking during the change evaluation interval.

Conditions

• Blood Pressure
• Blood Pressure Variability

Interventions

Type	Name	Description
DEVICE	A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer	The investigation medical device under evaluation is oCareTM BP 100, a non-invasive continuous blood pressure monitoring system developed by Taiwan Biophotonic Co. (tBPC). The main function is to use a fingerclip sensor to receive PPG signals and collect continuous blood pressure values and uninterruptedly within the initialization time. In this study, according to the latest released ISO 81060-3:2022 standard requirements, non-invasive blood pressure measurement by cuff at the start and the end time points will be used as oCareTM BP 100 start-to-end blood pressure calibration. The A-line invasive arterial catheter blood pressure measurement will be used as a reference invasive BPM equipment. The purpose of the study is to confirm the stability of the investigational medical device under evaluation and its performance of blood pressure change tracking.

Timeline

• Start date: 2023-11-29
• Primary completion: 2024-09-19
• Completion: 2024-11-26
• First posted: 2025-02-07
• Last updated: 2025-02-07

Locations

1 site across 1 country: Taiwan