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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02736006
Other study ID # RB15.173 (DACODEC)
Secondary ID
Status Completed
Phase N/A
First received March 16, 2016
Last updated June 12, 2017
Start date March 22, 2016
Est. completion date May 30, 2017

Study information

Verified date June 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Brest, University Hospital Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous bubbles will be detected by precordial Doppler Venous bubbles will be detected by precordial Doppler 30 minutes after the dive
Secondary Vascular abnormality Assessement of microvascular reactivity by brachial artery flow mediated dilation 60 minutes after the dive
Secondary Coagulation activation Assessment of blood coagulation factor after the dive 60 minutes after the dive
Secondary Inflammatory activation Assessment of inflammatory factor after the dive 60 minutes after the dive
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