Back to resultsDecreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks (DACODEC)
Primary Purpose
Decompression Sickness
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
20 meters air dive
Sponsored by
About this trial
This is an interventional basic science trial for Decompression Sickness focused on measuring Alveolo-capillar membrane, decompression illness, diving, occupational
Eligibility 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
Sites / Locations
- Brest, University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
20 meters air dive
Arm Description
Outcomes
Primary Outcome Measures
Venous bubbles will be detected by precordial Doppler
Venous bubbles will be detected by precordial Doppler
Secondary Outcome Measures
Vascular abnormality
Assessement of microvascular reactivity by brachial artery flow mediated dilation
Coagulation activation
Assessment of blood coagulation factor after the dive
Inflammatory activation
Assessment of inflammatory factor after the dive
Full Information
NCT ID
NCT02736006
First Posted
March 16, 2016
Last Updated
June 12, 2017
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02736006
Brief Title
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
Acronym
DACODEC
Official Title
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 22, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompression Sickness
Keywords
Alveolo-capillar membrane, decompression illness, diving, occupational
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 meters air dive
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
20 meters air dive
Intervention Description
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 Measure Information:
Title
Venous bubbles will be detected by precordial Doppler
Description
Venous bubbles will be detected by precordial Doppler
Time Frame
30 minutes after the dive
Secondary Outcome Measure Information:
Title
Vascular abnormality
Description
Assessement of microvascular reactivity by brachial artery flow mediated dilation
Time Frame
60 minutes after the dive
Title
Coagulation activation
Description
Assessment of blood coagulation factor after the dive
Time Frame
60 minutes after the dive
Title
Inflammatory activation
Description
Assessment of inflammatory factor after the dive
Time Frame
60 minutes after the dive
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Brest, University Hospital
City
Brest
Country
France
12. IPD Sharing Statement
Learn more about this trial
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
We'll reach out to this number within 24 hrs