A Single-Center, Prospective Clinical Study to Demonstrate That mCVI(R) Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Traditional Measurements of the Nonin Lifesense Capnograph
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Respiration Rate Verification
研究概览
简要总结
This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to traditional measurements of the Nonin Lifesense Capnograph. This is a non significant risk device.
详细描述
In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to traditional measurements of the Nonin Lifesense Capnograph.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between the ages of 21 - 70
排除标准
- •Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
- •Medications that could compromise a participant's ability to participate in the study
- •Documented medical history of respiratory or cardiovascular disease
- •Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
- •Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
- •Recent (≤ 1 month) surgical procedure of any kind
- •Current participation in another investigational clinical trial
- •Inability to provide informed consent
结局指标
主要结局
Respiration Rate Verification
时间窗: 1 month
To demonstrate that mCVI(R) accurately captures respiratory rate in comparison to Nonin Lifesense Capnograph
Pulse Rate Verification
时间窗: 1 month
To demonstrate that mCVI(R) accurately captures pulse rate comparison to Nonin Lifesense Capnograph
次要结局
- Skin Tone Pulse Rate Verification(1 month)
- Skin Tone Respiration Rate Verification(1 month)