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Trial record 43 of 137 for:    carbon monoxide

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

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ClinicalTrials.gov Identifier: NCT02736006
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Decompression Sickness Other: 20 meters air dive Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
Actual Study Start Date : March 22, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Arm Intervention/treatment
Experimental: 20 meters air dive Other: 20 meters air dive

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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736006


Locations
France
Brest, University Hospital
Brest, France
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02736006     History of Changes
Other Study ID Numbers: RB15.173 (DACODEC)
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by University Hospital, Brest:
Alveolo-capillar membrane
decompression illness
diving
occupational

Additional relevant MeSH terms:
Decompression Sickness
Barotrauma
Wounds and Injuries
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs