Clinical trial NCT06491433: Clinical Trial of H2-BP Electronic Sphygmomanometer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Blood Pressure
Normal Blood Pressure
Prehypertension
Hypertension
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 141
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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 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.

Primary outcomes:
measure: Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
timeFrame: serial assessment during 1 day
Secondary outcomes:
measure: Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
timeFrame: secondary outcome will be out in 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital,
Study officials:
References: