Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
DACODEC
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2016
CompletedStudy Start
First participant enrolled
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2017
CompletedJune 14, 2017
June 1, 2017
1.2 years
March 16, 2016
June 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Venous bubbles will be detected by precordial Doppler
Venous bubbles will be detected by precordial Doppler
30 minutes after the dive
Secondary Outcomes (3)
Vascular abnormality
60 minutes after the dive
Coagulation activation
60 minutes after the dive
Inflammatory activation
60 minutes after the dive
Study Arms (1)
20 meters air dive
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric
- Pregnant and nursing mothers
- Patient who refuse to sign consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brest, University Hospital
Brest, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
April 13, 2016
Study Start
March 22, 2016
Primary Completion
May 30, 2017
Study Completion
May 30, 2017
Last Updated
June 14, 2017
Record last verified: 2017-06