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临床试验/NCT02736006
NCT02736006已完成不适用

Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Venous bubbles will be detected by precordial Doppler

研究概览

简要总结

Diving disorders and particularly Decompression sickness (DCS) represent a major concern in recreational and occupational pressure-related activities. As a result of decompression from higher to lower ambient pressure bubbles which are formed in vascular flow and in tissues take part in embolism then resulting in DCS. Individual factors such as vascular or respiratory defects are now considered to increase the risk of this dysbarism disease.

详细描述

2 groups of occupational divers will be separated after a fitness medical examination by regarding DLCO decrease or not.

The divers will be evaluated before and 30, 60, 180 minutes after a 20 meters air dive. Venous bubbles will be detected by precordial Doppler 30 minutes after the dive.

In association with this Doppler, Flow Mediated Dilation, blood samples analysing inflammatory and thrombotic factors and other biomarkers will be explored before and after the dive in order to know how vascular and respiratory tracts in this environment react.

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

  • •Be professional and voluntary diver
  • •Man or woman aged 18 years or older
  • •Diffusing Lung Capacity for Carbon Monoxide measured beforehand in the study
  • •No medical contraindication for hyperbaric
  • •No hyperbaric constraint in 3 days before the dive
  • •No prior Decompression sickness
  • •Not to follow medicinal treatment modifying the vascular endothelial and/or the coagulation and/or the respiratory function
  • •Patient affiliated to social security
  • •Informed and signed

排除标准

  • •Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric
  • •Pregnant and nursing mothers
  • •Patient who refuse to sign consent form

研究组 & 干预措施

20 meters air dive

Experimental

干预措施: 20 meters air dive (Other)

结局指标

主要结局

Venous bubbles will be detected by precordial Doppler

时间窗: 30 minutes after the dive

Venous bubbles will be detected by precordial Doppler

次要结局

  • Inflammatory activation(60 minutes after the dive)
  • Vascular abnormality(60 minutes after the dive)
  • Coagulation activation(60 minutes after the dive)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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