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临床试验/NCT03192956
NCT03192956招募中不适用

Neuroskademarkörer Vid Dykarsjuka

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Biochemical signs of central nervous system injury

研究概览

简要总结

Research hypothesis

  • There is a correlation between the quantity of fluid markers of CNS injury in blood and DCS.
  • There is a correlation between quantity and kind of fluid markers of CNS injury in blood and both diving profile and severity of DCS.
  • There is a correlation between the quantity of inflammatory markers in blood an DCS.

Objectives:

  • Assess whether individuals suffering decompression sickness exhibit fluid markers of central nervous system injury.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical signs of neurological impairment.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical outcome after 3-6 months.
  • Assess whether individuals suffering decompression sickness exhibit inflammatory markers in blood.

详细描述

Decompression sickness (DCS) is a risk associated with diving. Common symptoms are joint and limb pain, skin rash, ataxia, hemiplegia, visual disturbances, paresthesias, limb numbness, nystagmus and vertigo. Treatment consists of recompression in a hyperbaric chamber, commonly referred to as hyperbaric oxygen treatment (HBOT).

It has been thought since the last quarter of the 19th century that DCS is caused by bubble formation in the tissues when dissolved inert gas comes out of solution. It was long thought that decompression schedules that did not give rise to any gas bubbles in the body also averted DCS. However, with the advent of ultrasound Doppler technology in the 1970s it was found that intravascular gas bubbles could exist even after uneventful dives. Dives well within limits established by military and sports authorities have been shown to generate intravascular bubbles. Hence, additional pathophysiological factors have been sought.

There is evidence of endothelial dysfunction, coagulopathy and inflammatory activation after diving. Though, their role in the pathophysiology of DCS remains to be determined.

Studies have shown that fluid markers of CNS injury can be found in blood samples obtained from athletes practising ice-hockey, boxing and american football. There is reason to believe that fluid markers of CNS injury will be present in blood samples obtained from divers with DCS as well.

Study subjects will be recruited by the attending physician at the Hyperbaric chamber at SU/Omrade 2 after the patient has been given a diagnosis of decompression sickness. Prior to treatment in the hyperbaric chamber, 4 ml of blood will be drawn via a plastic intravenous catheter that is placed in an arm vein as part of normal, established care of injured divers in the Emergency Department (to provide intravenous fluid and medications). A second 4 ml sample will be obtained from the same catheter after the patient has completed treatment (the typical hyperbaric treatment for decompression sickness lasts ~5.5 hours). The study object will also provide information regarding his/her general health and the completed dive. All study data, including blood samples, will anonymized and provided with a study code.

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

  • Presence of decompression sickness
  • Signed informed consent

排除标准

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

结局指标

主要结局

Biochemical signs of central nervous system injury

时间窗: 6 months

E. g: Tau, NfL, GFAP, UCHL-1

次要结局

  • Symptoms of decompression sickness(24 hours)
  • Dive time(1 hour)
  • Inflammatory activity(6 months)
  • Dive depth(1 hour)
  • Remaining symptoms of decompression sickness after 3-6 months(6 months)

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

Sahlgrenska University Hospital, Sweden

研究点 (1)

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