Clinical Trial of H2-BP Electronic Sphygmomanometer

Last updated: February 10, 2025
Sponsor: Gangnam Severance Hospital
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Williams Syndrome

Stress

Treatment

H2-BP

Clinical Study ID

NCT06491433
3-2022-0427
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Outpatients and inpatients aged 19 years or older showing hypotension, normal bloodpressure, prehypertension, and hypertension

  • Individuals who meet the criteria for wrist circumference, age, gender, and upperarm circumference as specified in the target number of participants.

  • Those who have listened to a detailed explanation of the clinical trial, fullyunderstand it, voluntarily decide to participate, and provide written consent tocomply with precautions.

Exclusion

Exclusion Criteria:

  • Patients who do not consent to participate in the study.

  • Individuals who may not maintain stable blood pressure for approximately 30 minutesdue to conditions resembling hypovolemia or similar conditions.

  • Those who may not maintain stable blood pressure for approximately 30 minutes due toshort-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 smokedwithin 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.

Study Design

Total Participants: 141
Treatment Group(s): 1
Primary Treatment: H2-BP
Phase:
Study Start date:
April 27, 2023
Estimated Completion Date:
October 15, 2024

Connect with a study center

  • Gangnam Severance Hospital,

    Seoul,
    Korea, Republic of

    Site Not Available

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