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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Prehypertension; Normal Blood Pressure; Low Blood Pressure
• Intervention / Treatment: Device: H2-BP

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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.; 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: Blood Pressure Measurement; Sphygmomanometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.	Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)	secondary outcome will be out in 1 day

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Prehypertension
• Other Study ID Numbers: 3-2022-0427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No