Bubbles, Stress, Diastole
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Best gas mixture
研究概览
简要总结
This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).
详细描述
The participants will be measured for vital parameters, blood samples and transthoracic cardiac ultrasound before diving (baseline).
Participants will be requested to perform recreational dive, which does not require particular decompression stops, at a depth of 30 meters with a 30 minutes botton time. 20 minutes after dive the same measurements as baseline will be repeated, once at rest and once after a physical effort by performing a series of 10 bending on the legs (squats). The day after dive, the participants will be interviewed by phone (FOLLOW-UP) by a physician. It will be required to report any unusual event, MDD symptom, or neurological complication.
Same procedure will be repeated with three different type of blends (AIR, NITROX, TRIMIX).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 60
- •healthy subjects
- •body mass BMI < a 30
- •physical status ASA 1
排除标准
- •subjects with significant clinical impairments such as important head trauma, general pain, low back pain, diabetes, asthma, cardiac and coagulation dysfunctions
- •pregnant women
- •participation in another study in the last 3 months
- •use of drugs and alcohol
- •psychiatric disorder
结局指标
主要结局
Best gas mixture
时间窗: 1 month
Best gas mixture with minimal cardiac function impact (endothelial stress)
次要结局
- diastolic function evaluation(1 month)
研究者
Dr. med. Claudio Camponovo
Principal Investigator
Clinica ARS Medica