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

NCT06815614 | Completed

• 1 other identifier: tBPC-BP-202309072DS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Blood Pressure Variability

Keywords

ISO 81060-3:2022; Photoplethysmography

Outcome Measures

Primary Outcomes (2)

• Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period

  4 hours

• Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval

  4 hours

Interventions

A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer DEVICE

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted in the National Taiwan University Hospital Hsin-Chu Branch. A total of 30\~40 patients are intended to be recruited.

You may qualify if:

• Subject must be over 22 years old on the date of informed consent.
• Subject who has undergone radial artery cannulation (A-line) (for medical purposes, specifically for arterial pressure monitoring.
• Subject or his/her legal representative understand the written informed consent and willing to participate as evidenced by signing the informed consent.

You may not qualify if:

• Pregnancy
• Patients with an intra-aortic balloon pump
• Patients with arm or finger injuries
• Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
• Patients with A-line placement in the brachial artery
• Participants or his/her legal representative refuse to sign the informed consent form

Sponsors & Collaborators

• Taiwan Biophotonic Corporation: lead

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 30059, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: February 7, 2025
• Study Start: November 29, 2023
• Primary Completion: September 19, 2024
• Study Completion: November 26, 2024
• Last Updated: February 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)