Validation of the Blood Pressure Monitoring Function

Validation of the Blood Pressure Monitoring Function of a Fingertip Photoplethysmography

High blood pressure is a major risk factor for cardiovascular diseases, stroke, and kidney disorders. Accurate blood pressure monitoring is crucial for the diagnosis, treatment, and prevention of complications related to high blood pressure. In recent years, due to the rapid development of wearable devices and mobile technology, wearable blood pressure monitors have gradually become a non-invasive and convenient method for blood pressure monitoring. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiHeart (an application program) in blood pressure measurement.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: RadiHeart

Detailed Description

Following the ISO 81060-2:2018 standard, the accuracy of RadiHeart will be evaluated by comparing the blood pressure values obtained by the device with those measured by a conventional mercury sphygmomanometer. This research is expected to recruit 170 adults aged 20 and above. All participants will undergo blood pressure measurements using both RadiHeart and a mercury sphygmomanometer. Participants will operate RadiHeart under the guidance of the testing personnel, while the mercury sphygmomanometer will be operated by trained healthcare professionals. The blood pressure measurement results from both devices will be recorded simultaneously, and the consistency between the blood pressure values measured by RadiHeart and the traditional mercury sphygmomanometer will be compared to validate the accuracy of the blood pressure application.

• Study Type: Observational
• Enrollment (Estimated): 170

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This trial expects to enroll 170 participants. The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Description

Inclusion Criteria:

The subjects should be aged 20 or older, with an equal gender distribution of 50% male and 50% female. From this group, 85 subjects with reasonable data values will be selected, with a requirement that at least 30% of them are male and at least 30% are female. Additionally, they must meet the following blood pressure conditions:

1. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≥ 160 mmHg (21.33 kPa).
2. At least 20% (17 individuals) of the participants should have reference systolic blood pressure readings ≥ 140 mmHg (18.66 kPa).
3. At least 5% (5 individuals) of the participants should have reference systolic blood pressure readings ≤ 100 mmHg (13.33 kPa).
4. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≤ 60 mmHg (8.0 kPa).
5. At least 20% (17 individuals) of the participants should have reference diastolic blood pressure readings ≥ 85 mmHg (11.33 kPa).
6. At least 5% (5 individuals) of the participants should have reference diastolic blood pressure readings ≥ 100 mmHg (13.33 kPa).

Exclusion Criteria:

1. Pregnant.

2. Having any of the following conditions:

   • Arrhythmia
   • Medical assessment indicates that poor blood circulation would affect the blood pressure data collection.
   • Involuntary hand movements that would affect the blood pressure data collector.
   • Nail polish on the light sensor area of the fingertip oximeter.
   • Other conditions as determined by a physician that make the individual unsuitable for participation in the trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in blood pressure (mean)	The mean value of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be within or equal to ±5.0 mmHg.	1 hour per individual
Difference in blood pressure (standard deviation)	The standard deviation of the differences in blood pressure measured by RadiHeart and the reference sphygmomanometer should be no greater than 8.0 mmHg.	1 hour per individual

Collaborators and Investigators

• Sponsor: RadiRad Co., Ltd.
• Collaborators: Hualien Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: blood pressure; Artificial Intelligence(AI) Algorithm
• Other Study ID Numbers: Validation of Blood Pressure

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