NCT06491433

Clinical Trial of H2-BP Electronic Sphygmomanometer

A Prospective, Single Arm, Single Center, Non-randomized, Open Label Study to Evaluate the Accuracy of the Wrist Blood Pressure Monitor (H2-BP) Comparing With Aneroid Sphygmomanometer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP.

Conditions

• Low Blood Pressure
• Normal Blood Pressure
• Prehypertension
• Hypertension

Interventions

Type	Name	Description
DEVICE	H2-BP	The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure. 1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen. 2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff. Due to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2024-07-09
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: South Korea