Validation of RespiLife for Detection of Respiratory Suppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- oxygen saturation percentage using photoplethysmography
研究概览
简要总结
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.
详细描述
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and sign the informed consent
- •English speaking.
- •Able to comply with visits and follow ups included in this protocol
- •Ages 18-80 years
排除标准
- •Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.
- •An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
- •If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.
- •Skin rash on the forehead.
- •A history of skin allergy to medical tape, even hypoallergenic tape.
- •A history of skin cancer on the forehead.
研究组 & 干预措施
Normal subjects
respiratory suppressing drugs
干预措施: Respilife monitor (Diagnostic Test)
结局指标
主要结局
oxygen saturation percentage using photoplethysmography
时间窗: 6 hours
The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer.
Respiratory rate, breaths per minute using photoplethysmography
时间窗: 6 hours
The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography.
次要结局
未报告次要终点