NCT06491433Completed
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 141 (actual)
- First submitted
- 30 Jun 2024
- Start date
- 27 Apr 2023
- Primary completion date
- 15 Oct 2024
- Lead sponsor
- Gangnam Severance Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06491433
What you commit to
- Study type: Interventional
- Participants enrolled: 141
- From 27 Apr 2023 to the primary completion date, 15 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.
Other illness
- Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.
- Individuals with arrhythmia.
Other
- Patients who do not consent to participate in the study.
- 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.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.