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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
时间窗: 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).
次要结局
- Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.(secondary outcome will be out in 1 day)
研究者
Byoung Kwon Lee
Professor
Gangnam Severance Hospital