An interventional study of H2-BP in Low Blood Pressure, Normal Blood Pressure and Prehypertension, sponsored by Gangnam Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Diagnostic
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's enrollment of 141 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Gangnam Severance Hospital is the lead sponsor of 146 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
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. 1. 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. 2. 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.
Also known as: Sphygmomanometer, Blood Pressure Measurement
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).
Time frame: serial assessment during 1 day
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)
Time frame: secondary outcome will be out in 1 day
| Milestone | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| Started | 141 |
| Completed | 87 |
| Not completed | 54 |
| Withdrew: Protocol violation | 51 |
| Withdrew: Consent withdrawal | 2 |
| Withdrew: Screen failure | 1 |
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).
| kPa | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| systolic blood pressure | 0,276 ± 0,937 |
| diastolic blood pressure | -0,004 ± 0,904 |
Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)
| kPa | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| systolic blood pressure | 0,276 ± 0,789 |
| diastolic blood pressure | -0,004 ± 0,735 |
Collected over 1day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Subjects Using H2-BP and Big Ben® Sphygmomanometer | — | — | — |
| Age, Categorical(Participants) | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 83 |
| >=65 years | 4 |
| Age, Continuous(years) | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| Mean | 44.69 ± 12.62 |
| Sex: Female, Male(Participants) | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| Female | 42 |
| Male | 45 |
| Race (NIH/OMB)(Participants) | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 87 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2023 to primary completion in Oct 2024, 17 months.
Results were first posted in Mar 2025, 4 months after primary completion.
Of 210 non-industry interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 17 months is above that.
Counting every sponsor, half of 217 studies reached it within 12 months; a quarter within 6 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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