Clinical Trial of H2-BP Electronic Sphygmomanometer

NCT ID: NCT06491433

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2024-10-15

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Test subjects using H2-BP and big ben® Sphygmomanometer

Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer).

Group Type: EXPERIMENTAL

H2-BP

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Sphygmomanometer; Blood Pressure Measurement

Eligibility Criteria

Inclusion Criteria

• Outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension
• Individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants.
• Those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions.

Exclusion Criteria

• Patients who do not consent to participate in the study.
• Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.
• Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.
• Individuals with arrhythmia.
• Those who have eaten within 30 minutes before blood pressure measurement.
• Individuals who have consumed caffeine-containing beverages within 1 hour or smoked within 15 minutes before measurement.
• Participants who have exercised immediately before blood pressure measurement.
• Other patients deemed unsuitable for the study at the discretion of the researchers.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Byoung Kwon Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severance Hospital,

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3-2022-0427

Identifier Type: -

Identifier Source: org_study_id