ClinicalTrials.gg
CompletedNCT02736006DACODECUpdated Jun 14, 2017

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

An interventional study of 20 meters air dive in Decompression Sickness, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Decompression Sickness

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Keywords

  • Alveolo-capillar membrane
  • decompression illness
  • diving
  • occupational
03

In context

Decompression Sickness

21 studies on the registry are indexed under Decompression Sickness; 6 are open to participants now.

Browse Decompression Sickness studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  • Concomitant pathology identified by the Investigator, justifying a for hyperbaric
  • Pregnant and nursing mothers
  • Patient who refuse to sign consent form
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    20 meters air dive

    Other: 20 meters air dive

Interventions

  • Other20 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.

06

What researchers measure

Primary outcomes

  1. Venous bubbles will be detected by precordial Doppler

    Venous bubbles will be detected by precordial Doppler

    Time frame: 30 minutes after the dive

Secondary outcomes

  1. Vascular abnormality

    Assessement of microvascular reactivity by brachial artery flow mediated dilation

    Time frame: 60 minutes after the dive

  2. Coagulation activation

    Assessment of blood coagulation factor after the dive

    Time frame: 60 minutes after the dive

  3. Inflammatory activation

    Assessment of inflammatory factor after the dive

    Time frame: 60 minutes after the dive

07

Study locations

1 site
  • Brest, University Hospital
    Brest, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in May 2017, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2016
First posted
Apr 13, 2016
StartActual
Mar 22, 2016
Primary completionActual
May 30, 2017
CompletionActual
May 30, 2017
Last update
Jun 14, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02736006
Responsible party
Sponsor
First posted
Apr 13, 2016
Start date
Mar 22, 2016
Primary completion
May 30, 2017
Completion
May 30, 2017
Last update
Jun 14, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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