Early Pulmonary Effects of Excursion Deep Diving With Closed-circuit Gas Recycling: SPIDD Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Variation in Vital Capacity Measurement before and after diving
研究概览
简要总结
Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities.
The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. More and more divers are seeking to reach depths previously considered unusual or inaccessible in recreational diving, beyond 100 meters. By pushing back these limits, the diver is exposed to new risks which should lead to a reflection on the means of prevention and treatment in case of incident.
The physiological repercussions of these deep dives are not well known. During daily deep excursions in the 90-120 meter zone, there is a significant reduction in vital capacity on leaving the dive, which persists and worsens the following day.
It seems necessary to confirm the importance of this impairment, never documented before, and to explore its mechanisms. A better knowledge of this respiratory impact could allow to improve the prevention and the preliminary evaluation of the medical aptitude of these divers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diver ≥ 18 years old
- •Recreational rebreather diver with a recognised qualification (Mixed Gas CCR training or equivalent) and the necessary experience for this type of diving who has scheduled a dive in the 60 metre depth zone
- •Diver using his/her own equipment, i.e. a closed circuit rebreather with back lungs meeting CE standards.
- •Having a medical certificate of no contraindication to the practice of underwater activities < 1 year issued by an authorised doctor
- •Having taken out personal insurance covering this type of activity
- •Voluntary and having given his/her express, free and informed consent
- •Affiliated to the Social Security
排除标准
- •Diver refusal
- •Known previous respiratory pathology
- •Use of medication that may alter pulmonary and/or vascular function as well as inflammatory and haemostasis parameters
- •Any temporary contraindication to the practice of scuba diving
- •Patient under guardianship or trusteeship
- •Immersion beyond 30 metres within 7 days or any scuba diving within the previous 48 hours.
研究组 & 干预措施
Diving arm
The standard arm involves all participants in the study. Subjects will perform pre-dive and post-dive examinations to characterize the respiratory impact of deep water diving
干预措施: Pre and post dive examinations (Diagnostic Test)
结局指标
主要结局
Variation in Vital Capacity Measurement before and after diving
时间窗: Day +1
Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))
次要结局
- Variations in lung ultrasound (B lines) before and after diving(Day +1)
- Variations in lung ultrasound (condensations) data before and after diving(Day +1)
- Variations in right ventricle function data before and after diving(Day +1)
- Variations in biological markers of coagulation activation before and after diving(Day +1)
- Variations in lung ultrasound (condensations) before and after diving(Day 0 (after diving))
- Variations in DLCO before and after diving(Day +1)
- Variations in decompression (circulating bubbles) data before and after diving(Day 0 (after diving))
- Variations in biological markers of inflammation before and after diving(Day +1)
- Variations in water balance before and after diving(Day +1)
- Variations in Spirometry data before and after diving(Day +1)
- Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving(Day +1)
- Variations in biomarkers of lipid peroxidation before and after diving(Day +1)
- Variations in biomarkers of oxidative stress before and after diving(Day +1)
- Variations in plethysmography data before and after diving(Day +1)