Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Device comparison to standard monitoring (Sphygmomanometer)
研究概览
简要总结
Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor offers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are able to provide informed consent
- •Have at least one arm
排除标准
- •Active cardiac arrhythmias
- •Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
- •Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
- •Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
- •Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
- •Diagnosis of dementia
结局指标
主要结局
Device comparison to standard monitoring (Sphygmomanometer)
时间窗: 4 years
Clinical feasibility of the device accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 90 participants in consulting room on orthostatic hypotension participants.
Device comparison to standard monitoring (A-line)
时间窗: 3 years
Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.
次要结局
未报告次要终点
研究者
Sheng Xu
Associate Professor
University of California, San Diego