NCT04935190Unknown不适用
Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
DawnLight1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of Respiratory Rate
研究概览
简要总结
- Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor.
- Determine agreement (accuracy) of resting respiratory rate measured by Vitalpercept when compared to an FDA-cleared capnographer, Capnostream 20.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects ≥ 21 years of age at the time of signing the informed consent.
- •Subjects willing to sign the informed consent and capable of committing to the duration of the study.
- •Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair.
- •Subjects who are able to breathe through their nose for the capnography assessment.
- •Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group
- •Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.
排除标准
- •Subjects who are prone to excessive coughing and excessive movement
- •Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor.
- •Subjects with a history of allergy to adhesive, latex or Nuprep.
结局指标
主要结局
Measurement of Respiratory Rate
时间窗: During Data collection-Expected time=45-60 minutes
Effectiveness
Incidence of Adverse events
时间窗: During Data collection-Expected time=45-60 minutes
Safety
Measurement of Heart Rate
时间窗: During Data collection-Expected time=45-60 minutes
Effectiveness
次要结局
未报告次要终点
研究者
研究点 (1)
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