Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Quality of the vascular Doppler signal: scale
研究概览
简要总结
The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.
- Electrocardiogram
- Vascular doppler
- Laser doppler with iontophoresis
- Continuous blood pressure recording at the finger level
- Brachial blood pressure
- Ultrasound
- Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Height between 160 et 180 cm
- •Body mass index between 18 et 24
- •Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
- •Normal electrocardiogram
- •Possibility to perform transcranial doppler
- •Able to understand aims and constraints of this study
- •National health insurance
- •Signature of the informed consent form
排除标准
- •Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
- •Participating at the time to another clinical trial investigating
- •Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
- •Taking any chronic treatment
- •Any sign of cardiovascular or respiration disease
- •Any sign of syncopal events by questioning (>2 events per year)
- •Contraindication to perform physical activity
结局指标
主要结局
Quality of the vascular Doppler signal: scale
时间窗: Through study completion, an average of 6 months
Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the ambulatory measurements (ECG / SAO2)
时间窗: Through study completion, an average of 6 months
ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the ECG signal given by CARDIOSPACE II: scale
时间窗: Through study completion, an average of 6 months
ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the laser doppler signal: scale
时间窗: Through study completion, an average of 6 months
Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the ultrasound images: scale
时间窗: Through study completion, an average of 6 months
Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image
Quality of the blood pressure wave: scale
时间窗: Through study completion, an average of 6 months
Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
次要结局
未报告次要终点