Clinical Trial of H2-BP Electronic Sphygmomanometer

NCT06491433 | Completed Results

• 1 other identifier: 3-2022-0427
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.

  Average difference between blood pressure measurements obtained with the test medical device and the comparator. Standard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements).

  serial assessment during 1 day

Secondary Outcomes (1)

• Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.

  secondary outcome will be out in 1 day

Study Arms (1)

Test subjects using H2-BP and big ben® Sphygmomanometer

EXPERIMENTAL

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

Device: H2-BP

Interventions

H2-BP 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.

Also known as: Sphygmomanometer, Blood Pressure Measurement

Test subjects using H2-BP and big ben® Sphygmomanometer

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Gender Eligibility Description: At least 30% of the total participants must be composed of each gender (male and female)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital,

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypotension; Prehypertension; Hypertension

Interventions

Sphygmomanometers; Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Results Point of Contact

• Title: Byoung Kwon Lee
• Organization: Department of Cardiology at Gangnam Severance hospital

CARDIOBK@yuhs.ac

+82-10-2721-8813

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 9, 2024
• Study Start: April 27, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Locations

KR (1)