SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparative data of monitoring respiratory by 2 technologies
研究概览
简要总结
SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.
详细描述
Patients performing endoscopy procedures under sedation at the gastro clinic will be monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist. All patients will be monitored using the same two techniques (SafeSed and Capnography). No clinical decisions will be made based upon the data generated by the SafeSed system.
The data from all sources will be compared (post factum) to validate SafeSed performance.
The data collected on the SafeSed prototype will not be used for treatment of the patient.
The comparative analysis will be free vto be used by the sponsor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •class 1-3 per American Society Anesthesiologists Physical Status Classification
- •Subject signed Informed Concent Form
排除标准
- •Pregnancy
- •Unresolved pulmonary infection requiring active treatment
- •Chronic pulmonary disease
- •Any othe medical condition, that treating physician determines participating in the study is unadvisable
结局指标
主要结局
Comparative data of monitoring respiratory by 2 technologies
时间窗: 4 months
Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.
次要结局
未报告次要终点