Decompression SicknessDACODECNCT02736006
Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
A study testing 20 meters air dive in people with Decompression Sickness, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Decompression Sickness
- What is being tested?
- 20 meters air dive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2016to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric
- Pregnant and nursing mothers
- Patient who refuse to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Decompression Sickness
- Being tested
- 20 meters air dive
- Keywords
- Alveolo-capillar membrane, decompression illness, diving, occupational
- Medical subject headings
- Decompression Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 meters air diveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 meters air dive | Experimental | Not described Receives: Other: 20 meters air dive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous bubbles will be detected by precordial Doppler
Venous bubbles will be detected by precordial Doppler
Measured: 30 minutes after the dive
Secondary outcomes (3)
Vascular abnormality
Assessement of microvascular reactivity by brachial artery flow mediated dilation
Measured: 60 minutes after the dive
Coagulation activation
Assessment of blood coagulation factor after the dive
Measured: 60 minutes after the dive
Inflammatory activation
Assessment of inflammatory factor after the dive
Measured: 60 minutes after the dive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start22 Mar 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736006
- Sponsor's protocol ID
- RB15.173 (DACODEC)
- Acronym
- DACODEC
- Status last verified
- Jun 2017
- First submitted
- 16 Mar 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreases in Diffusing Lung Capacity for Carbon Monoxide (DLCO) in Occupational Divers and Their Impact on Decompression Sickness Risks
- ClinicalTrials.gov ID
- NCT02736006
- Acronym / sponsor ID
- DACODEC / RB15.173 (DACODEC)
- Conditions
- Decompression Sickness
- Keywords
- Alveolo-capillar membrane, decompression illness, diving, occupational
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 meters air dive | Experimental | Other: 20 meters air dive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Concomitant pathology identified by the Investigator, justifying a contraindication for hyperbaric
- Pregnant and nursing mothers
- Patient who refuse to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20 meters air diveA 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. | Other | 20 meters air dive |
Primary outcome
Venous bubbles will be detected by precordial Doppler
Time frame: 30 minutes after the dive
Venous bubbles will be detected by precordial Doppler
3 secondary outcomes
Vascular abnormality
Time frame: 60 minutes after the dive
Coagulation activation
Time frame: 60 minutes after the dive
Inflammatory activation
Time frame: 60 minutes after the dive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20 meters air dive in people with Decompression Sickness, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous bubbles will be detected by precordial Doppler (time frame: 30 minutes after the dive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.