Calibration of a New Reflectance Oximeter.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Calibration of the oximeter in normoxic situation
研究概览
简要总结
This study is about the development of a new medical device for the monitoring of of sleep disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of an oximeter, an actimeter in order to measure the activity level of the subject, his state of sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).
Developing this device is realized in several steps : a study (ALMOST) is already in progress and its goal is to acquire a database of polysomnography to create automatic algorithms in order to detect respiratory disorders with this device under development.
The main goal of the study is to calibrate the oxymeter under development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects (both gender) aged between 18 to 50 years affiliated to a certain social security, that has given their free consent to participate to the study
- •Subjets without any pathology known and not under medical treatment likely to suffer from controlled hypoxia at levels demanded in the protocol.
- •Subjets having a regular practice of sport
排除标准
- •Subjet non affiliated to a certain social security
- •Smoker or person exposed to passive smoking
- •History of acute mountain sickness or known sensitivity to hypoxia
- •Any chronic pathology known, in particular pathologies behind high rates of methaemoglobin
- •Pregnant, parturient or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under a legally protected order and could'nt be included in clinical trials (persons mentioned in L1121-5 to L1121-8 of CSP).
- •Subjets likely to not be cooperative or respectful of the inherent constraints to study participation.
结局指标
主要结局
Calibration of the oximeter in normoxic situation
时间窗: 2 hours
Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2
Calibration of the oximeter in hypoxia situation
时间窗: 2 hours
Measures with ALTITRAINER200® system Situation 1 : 90 % (92-88%) partial pressure in O2 Situation 2 : 85% (87-83%) partial pressure in O2 Situation 3 : 80% (82-78%) partial pressure in O2 Situation 4 : 75%(77%-73%) partial pressure in O2
次要结局
未报告次要终点