Validation of the Blood Pressure Monitoring Function

Blood Pressure Clinical Trial

Official title:

Validation of the Blood Pressure Monitoring Function of a Fingertip Photoplethysmography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104501
• Other study ID #: Validation of Blood Pressure
• Status: Not yet recruiting
• Start date: October 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: RadiRad Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
RadiRad Co., Ltd.	Hualien Tzu Chi General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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