Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Cuffless blood pressure measurement performance
研究概览
简要总结
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
详细描述
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years or older,
- •Willing and able to provide informed consent,
- •Able to comply with study procedure.
排除标准
- •Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference > 42 cm),
- •Patient with a pacemaker,
- •History of reactions to medical adhesives,
- •Inability to comply with the study procedure,
- •Non-English Speaker.
结局指标
主要结局
Cuffless blood pressure measurement performance
时间窗: 3 months
Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.
次要结局
- Demographic performance variance(3 months)