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

Decompression Sickness Clinical Trial

— DACODEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736006
• Other study ID #: RB15.173 (DACODEC)
• 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
• 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

Related Conditions & MeSH terms

• Decompression Sickness

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