NCT06104501

Validation of the Blood Pressure Monitoring Function

Validation of the Blood Pressure Monitoring Function of a Fingertip Photoplethysmography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 170 (estimated)
• Sponsor: RadiRad Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-20
• Primary completion: 2023-12-31
• Completion: 2024-05-31
• First posted: 2023-10-27
• Last updated: 2023-10-27