NCT06368206招募中不适用
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aktiia SA
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Number of study subjects that contribute with analyzable raw data collected
研究概览
简要总结
The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 21 to 85yo
- •Subjects fluent in written and spoken French
- •Subjects agreeing to attend the study visit and follow study procedures
- •Subjects that have signed the informed consent form.
排除标准
- •Amputated index fingers
- •Damaged/injured skin at index fingers
- •Damaged/injured skin at wrists
- •Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
- •Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
- •Pregnant women
- •Polyneuropathy
结局指标
主要结局
Number of study subjects that contribute with analyzable raw data collected
时间窗: 1 hour
Min 85 study subjects contribute with analyzable raw data collected
次要结局
- Pulse rate root-mean-square error(1 hour)
- Blood pressure mean value of differences(1 hour)
- Blood pressure standard deviation of differences(1 hour)
研究者
研究点 (2)
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