NCT03992651已完成不适用
Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparison of capnia values
研究概览
简要总结
This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Males or females between 18 and 50 year old
- •Individual having health insurance
- •Individual able to provided informed consent
- •Subjects with no known pathology and not taking any medical treatment a priori capable of interfering with controlled hypoxia at levels required in the protocol
排除标准
- •Body mass index >27 kg/m²
- •History of acute mountain sickness
- •Chronic diseases know to be associated with high methemoglobinemia
- •Known allergy to one of the materials used in the devices (lycra, polyamide...), or to the adhesive plaster.
- •Active smoker (>3 cigarets/day)
- •Alcohol consumption (>10g/day)
- •Individual with high skin sensitivity due to skin diseases
- •Mental disorders
- •Persons who refuse to sign the information sheet and participation agreement
- •Persons under guardianship or not subject to a social security system
- •Pregnant woman, parturient, breastfeeding mother
- •Person deprived of liberty by judicial or administrative decision
- •A person who is subject to a legal protection measure that cannot be included in clinical trials.
结局指标
主要结局
Comparison of capnia values
时间窗: Continuous measurement during the only experimental session (1 hour)
Comparison of capnia values measured by the new sensors and the standard laboratory sensors
次要结局
- Comparison of tissue oxygenation values(Continuous measurement during the only experimental session (1 hour))
研究者
研究点 (2)
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