Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Evolution of decompression sickness clinical symptoms
研究概览
简要总结
The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness.
In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria.
Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells.
The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes.
The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Healthy subject with no contraindications to diving OR patient admitted to the hospital for suspicion of a diving accident OR patient admitted to the hospital for hyperbaric oxygen therapy
排除标准
- •Contraindication to diving or contraindication to hyperbaric oxygen therapy
结局指标
主要结局
Evolution of decompression sickness clinical symptoms
时间窗: Until the end of the oxygen therapy treatment (up to 1 year)
Decompression sickness clinical symptoms will be assessed through a medical examination after each hyperbaric session. Decompression sickness clinical symptoms include: paresthesia, sensory deficit, motor deficit, spinal pain, sphincter disorder and brain injury. The evolution of symptoms will be rated as following: total regression, improvement, stabilization, fluctuation or worsening
次要结局
未报告次要终点