跳至主要内容
临床试验/NCT03192930
NCT03192930已完成不适用

Inflammatoriska Och Neurokemiska förändringar Vid ökat Omgivningstryck

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2017年3月17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
26
试验地点
1
主要终点
Concentration of inflammatory and cerebrospinal biochemical markers in blood

研究概览

简要总结

Research hypothesis

  • Prolonged hyperbaric exposure will affect the central nervous system
  • Prolonged hyperbaric exposure will induce inflammatory changes
  • Prolonged hyperbaric exposure will affect fluid regulation in the body

Objectives:

  • To investigate the presence of cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of cerebrospinal biochemical markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate the presence of inflammatory markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of inflammatory markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate if prolonged hyperbaric exposure alters fluid balance in the body

详细描述

When diving with compressed air, a continuous accumulation of nitrogen will take place in the body. The total uptake of nitrogen by the tissues is dependent on the duration and depth of the performed dive. During prolonged exposure to hyperbaric conditions the body eventually will become saturated with nitrogen. In a hyperbaric environment corresponding to a depth of 30 meters seawater, nitrogen saturation could be expected after about 24 hours. Decompression can cause accumulated nitrogen to form intravascular bubbles.

It has long been considered that decompression sickness (DCS) is caused by bubble formation when dissolved nitrogen at the end of diving comes out of solution. Doppler ultrasound techniques have shown that intravascular gas bubbles could exist even after uneventful dives. Therefore, additional pathophysiological factors must be sought.

Dehydration is a common finding after diving in water. It is probably caused by a combination of a non-existent water intake during diving and a physiologically increased urine production, caused by the increased ambient pressure.

There is evidence of an increased inflammatory activity in blood after diving. Signs of neutrophil activation is a common finding. It is not known if hyperbaric exposure in itself is enough to elicit these biochemical changes or if the presence of intravascular nitrogen bubbles is needed.

Studies have shown that biochemical markers of central nervous system (CNS) injury can be detected in blood samples obtained from patients with DCS, metabolic and neurologic disease, during cardiac surgery and after traumatic brain injuries. Such markers can also be seen in blood after sport activities like boxing and breath hold diving. If biochemical markers of CNS injury will be present in blood after hyperbaric exposure is not known.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Submariners and divers employed by the Swedish navy or individuals approved by the Swedish navy for work in a hyperbaric Environment.
  • Subjects in the intervention group must be participating in the Swedish navy saturation diving tests.

排除标准

  • As this is a highly selected population there is no exclusion criteria.

结局指标

主要结局

Concentration of inflammatory and cerebrospinal biochemical markers in blood

时间窗: 14 days

E. g: tau, NfL, GFAP, UCHL-1, VCAM-1, ICAM-1, Endothemin-1 and others

次要结局

  • Biochemical signs of altered fluid balance in the body(7 days)
  • Changes in lung function(7 days)
  • Decompression sickness (DCS)(7 days)
  • Presence of Venous gas Emboli (VGE)(7 days)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Rosén

MD PhD student

Sahlgrenska University Hospital, Sweden

研究点 (1)

Loading locations...

相似试验