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

June 12, 2017 updated by: University Hospital, Brest
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • Brest, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous bubbles will be detected by precordial Doppler
Time Frame: 30 minutes after the dive
Venous bubbles will be detected by precordial Doppler
30 minutes after the dive

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular abnormality
Time Frame: 60 minutes after the dive
Assessement of microvascular reactivity by brachial artery flow mediated dilation
60 minutes after the dive
Coagulation activation
Time Frame: 60 minutes after the dive
Assessment of blood coagulation factor after the dive
60 minutes after the dive
Inflammatory activation
Time Frame: 60 minutes after the dive
Assessment of inflammatory factor after the dive
60 minutes after the dive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2016

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB15.173 (DACODEC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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