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

February 3, 2025 updated by: Taiwan Biophotonic Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 30059
        • National Taiwan University Hospital Hsin-Chu Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnancy
  2. Patients with an intra-aortic balloon pump
  3. Patients with arm or finger injuries
  4. Patients who have undergone vascular surgery for upper extremities or contraindications for local treatment upon upper extremities
  5. Patients with A-line placement in the brachial artery
  6. Participants are considered not suitable for inclusion after evaluation by the researchers (such as poor compliant mental status or health conditions, etc.)
  7. Participants or his/her legal representative refuse to sign the informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
Time Frame: 4 hours
4 hours
Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Biophotonic Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Actual)

September 19, 2024

Study Completion (Actual)

November 26, 2024

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • tBPC-BP-202309072DS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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