Hypertension, Low Blood Pressure, Normal Blood Pressure, Prehypertension
Conditions
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.
Interventions
DEVICEH2-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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | serial assessment during 1 day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | secondary outcome will be out in 1 day | Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants) |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | consent withdrawal | 2 |
| Overall Study | Protocol Violation | 51 |
| Overall Study | screen failure | 1 |
Baseline characteristics
| Characteristic | Test Subjects Using H2-BP and Big Ben® Sphygmomanometer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 83 Participants |
| Age, Continuous | 44.69 years STANDARD_DEVIATION 12.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 87 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Subjects Using H2-BP and Big Ben® Sphygmomanometer | Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | systolic blood pressure | 0,276 kPa |
| Test Subjects Using H2-BP and Big Ben® Sphygmomanometer | Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | diastolic blood pressure | -0,004 kPa |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Test Subjects Using H2-BP and Big Ben® Sphygmomanometer | Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | systolic blood pressure | 0,276 kPa |
| Test Subjects Using H2-BP and Big Ben® Sphygmomanometer | Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. | diastolic blood pressure | -0,004 kPa |