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OpenTrials
Completed

NCT Number: NCT02736006

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

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.

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Key information

Conditions

Decompression Sickness Barotrauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brest, University Hospital

Brest, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

20 meters air dive

Other

A dive in the depth of 20 m during 40 minutes. 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.

Primary outcomes

  1. Venous bubbles will be detected by precordial Doppler

    Time frame: 30 minutes after the dive

    Venous bubbles will be detected by precordial Doppler

Secondary outcomes

  1. Vascular abnormality

    Time frame: 60 minutes after the dive

    Assessement of microvascular reactivity by brachial artery flow mediated dilation

  2. Coagulation activation

    Time frame: 60 minutes after the dive

    Assessment of blood coagulation factor after the dive

  3. Inflammatory activation

    Time frame: 60 minutes after the dive

    Assessment of inflammatory factor after the dive

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: DACODEC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2016
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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