Status:
COMPLETED
Clinical Trial of H2-BP Electronic Sphygmomanometer
Lead Sponsor:
Gangnam Severance Hospital
Conditions:
Low Blood Pressure
Normal Blood Pressure
Eligibility:
All Genders
19+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2024
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT06491433
Start Date
April 27 2023
End Date
October 15 2024
Last Update
March 3 2025
Active Locations (1)
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1
Gangnam Severance Hospital,
Seoul, South Korea