Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Comparison of Diastolic Blood Pressure
研究概览
简要总结
(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.
详细描述
(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.
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
- 否
入选标准
- •Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
- •Agree to commit to participate in the current protocol.
- •Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).
排除标准
- •Unable or unwilling to provide informed consent
- •Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
- •A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
- •Upper extremity arteriovenous hemodialysis shunt.
- •Wrist distortion or pain from arthritis.
- •Prior trauma or surgery at the radial artery monitoring site.
结局指标
主要结局
Comparison of Diastolic Blood Pressure
时间窗: up to 30 minutes
3 sets readings compared across blood pressure (mmHg)
Comparison of Systolic Blood Pressure
时间窗: up to 30 minutes
3 sets readings compared across blood pressure (mmHg)
次要结局
- Skin Irritation(Up to 72 hours)