Validation of a Noninvasive Automated Blood Pressure Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Systolic and Diastolic blood pressure (criteria 1 and 2)
研究概览
简要总结
The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.
详细描述
A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 92 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 12 to 92 years of age.
- •generally healthy but can be on medication for blood pressure regulation.
排除标准
- •heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
- •using a pacemaker to maintain a suitable heart rate.
- •missing their natural left arm.
- •exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (~40min) or prevent a BP reading taken from the left arm.
- •Special populations, for example pregnant women and patients with known arrhythmias.
结局指标
主要结局
Systolic and Diastolic blood pressure (criteria 1 and 2)
时间窗: 60 minutes
Mean value of the differences of the paired (i.e., device under test - reference method) determinations for all study participants shall be within or equal to ± 5 mmHg with a standard deviation no greater than 8 mmHg (criterion 1). Standard deviation of the averaged paired determinations per participant shall meet the criterion 2 listed in the standard.
次要结局
未报告次要终点
研究者
Todd Schroeder
Assistant Professor
University of Southern California