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Completed

NCT Number: NCT06491433

Clinical Trial of H2-BP Electronic Sphygmomanometer

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.

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Key information

Conditions

Low Blood Pressure Cardiovascular Diseases Hypertension Hypotension Normal Blood Pressure Prehypertension Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital,

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  • 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.
  • 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.

Other names: Sphygmomanometer, Blood Pressure Measurement

Primary outcomes

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

    Time frame: serial assessment during 1 day

    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).

Secondary outcomes

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

    Time frame: secondary outcome will be out in 1 day

    Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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