Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Mean error for blood pressure
研究概览
简要总结
This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (aged between 21 and 65)
- •Subjects fluent in written and spoken French
- •Subjects enrolled in a 12-weeks cardiac rehabilitation program
- •Subjects agreeing to participate
- •Subjects that have signed the informed consent form
排除标准
- •Subjects with tachycardia (heart rate at rest > 120bpm)
- •Subjects with atrial fibrillation
- •Subjects with severe heart failure (LVEF<35%)
- •Subjects with severe renal dysfunctions (eGFR < 30mL/min/1.73 m2)
- •Subjects with pheochromocytoma
- •Subjects with Raynaud's disease
- •Subjects with trembling and shivering
- •Subjects with interarm systolic difference > 15 mmHg
- •Subjects with interarm diastolic difference > 10 mmHg
- •Subjects with arm paralysis
- •Women in known pregnancy
- •Subjects with an arteriovenous fistula
- •Subjects with arm amputations
- •Subjects with the upper arm circumference > 64 cm
- •Subjects with the wrist circumference > 22 cm
- •Subjects with the exfoliative skin diseases
- •Subjects with lymphoedema
结局指标
主要结局
Mean error for blood pressure
时间窗: up to 24 hours
The mean error between the Reference and Aktiia.product for SYS and DIA in mmHg
Mean absolute error for blood pressure
时间窗: up to 24 hours
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for systolic (SYS) and diastolic (DIA) blood pressure in mmHg
Standard deviation of the error for blood pressure
时间窗: up to 24 hours
The standard deviation of the error between Reference and Aktiia.product for SYS and DIA in mmHg
Mean absolute error for heart rate
时间窗: up to 24 hours
The mean absolute error between the Reference (standard ambulatory blood pressure monitor) and Aktiia.product for heart rate in bpm
Mean error for heart rate
时间窗: up to 24 hours
The mean error between the Reference and Aktiia.product for heart rate in bpm
Standard deviation of the error for heart rate
时间窗: up to 24 hours
The standard deviation of the error between Reference and Aktiia.product for heart rate in bpm
次要结局
- Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program(12 weeks)
- Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.(1 week)
- Evaluation of patient's satisfaction for the two devices through a survey with multiple questions(up to 24 hours)
- Assessment of the calibration stability of Aktiia OBPM algorithms(12 weeks)
研究者
Cyril Pellaton
Cyril Pellaton
Hopital Neuchatelois