Validation of the Blood Pressure Monitoring Function

NCT ID: NCT06104501

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-05-31

Brief Summary

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.

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.

Conditions

Blood Pressure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

RadiHeart

The participants' blood pressure will be measured multiple times by both the mercury sphygmomanometer and RadiHeart, by using the same arm sequential method.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hualien Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

RadiRad Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Validation of Blood Pressure

Identifier Type: -

Identifier Source: org_study_id