Clinical trial NCT06815614: This Study Aims to Assess the Performances of Optical Blood Pressure Monitoring Device, tBPC Product With Reference to ISO 81060-3:2022
Official title: A Photoplethysmography-Based Continuous Automated Non-Invasive Sphygmomanometer: Performance Evaluation in Stability and Blood Pressure Change Tracking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Blood Pressure Variability
Keywords: ISO 81060-3:2022
Photoplethysmography
Lead sponsor: Taiwan Biophotonic Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Confirm the stability of the repeated measurements of SUT by calculating the corrected standard deviation of each analysis period
timeFrame: 4 hours
measure: Confirm the consistency of SUT vs. the reference BPM equipment by calculating the blood pressure change during the change evaluation interval
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu Branch
Study officials:
References: