Decompression SicknessTEKCareNCT06627153
Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity (TEKCare)
An observational study of Decompression Sickness and Pulmonary Edema - Acute, run by University Hospital, Brest at 1 site in France.
Trial summary
This retrospective study aims at an epidemiological description of the clinical presentation of medical problems in technical diving. It assess anthropometric data, diving experience and dive planification, clinical presentation, treatment received and pronostic to understand specificity of this community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompression Sickness, Pulmonary Edema - Acute, Oxygen Toxicity
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Technical divers are defined by specialized equipment (e.g. rebreather) and/or helium based mixed-gases used to conduct deeper and longer dives. All divers who consulted hyperbaric installations after one of these dives with a retained diagnosis of a diving accident are eligible to participate.
Who may be able to join
- Civilian technical diver
- Diving accident history (decompression sickness, biochemical accident or immersion pulmonary edema) following a technical dive in a trimix and/or rebreather dive
- Treated in a hyperbaric center on the coast of mainland France
Who cannot join
- Participation denied by the diver
- Diving incident diagnosis not retained by the hyperbaric physician
Trial locations and contacts
1 site in 1 country.
Emmanuel GOUIN contact
About this study
Official title: Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity
This retrospective study aims at an epidemiological description of the clinical presentation of medical problems in technical diving. It assess anthropometric data, diving experience and dive planification, clinical presentation, treatment received and pronostic to understand specificity of this community.
Read the detailed description
In recent years, the increased availability of breathing gas mixtures, together with progressive technical development of specialized diving equipment, has contributed to expansion of the diver's community. Deep and long dives expose to decompression sickness (DCS) risk and hyperbaric oxygen therapy (HBO) is the definitive treatment. Incidence, clinical expression or prognosis of pathological events after technical diving might differ from recreational ones. A better knowledge of these specificity will facilitate risk assessment, analysis and medical care for hyperbaric physician community.
- Conditions
- Decompression Sickness, Pulmonary Edema - Acute, Oxygen Toxicity, Carbon Dioxide Poisoning, Nitrogen Narcosis
- Medical subject headings
- Decompression Sickness, Inert Gas Narcosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic description of injured technical divers treated in French hyperbaric center
Comparison of technical diver populations according to length of hospitalization (< 48 hours vs > 48 hours) corresponding to treatment with simple hyperbaric oxygen therapy or requiring several consolidation sessions in view of the severity and/or intensity of symptoms.
Measured: 15 years
Secondary outcomes (1)
Predictive factor of severity
Evaluation regarding the number of OHB treatment (reflecting the gravity if more than 2) and diving profil (breathing apparatus, maximal depth, dive total time, composition of mixed gas), demographic profile of divers (age, sex, medical conditions) and symptoms presentation.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627153
- Sponsor's protocol ID
- 29BRC24.0150 - TEKCare
- Acronym
- TEKCare
- Status last verified
- Jun 2024
- First submitted
- 23 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity
- ClinicalTrials.gov ID
- NCT06627153
- Acronym / sponsor ID
- TEKCare / 29BRC24.0150 - TEKCare
- Conditions
- Decompression Sickness, Pulmonary Edema - Acute, Oxygen Toxicity, Carbon Dioxide Poisoning, Nitrogen Narcosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- 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.
This retrospective study aims at an epidemiological description of the clinical presentation of medical problems in technical diving. It assess anthropometric data, diving experience and dive planification, clinical presentation, treatment received and pronostic to understand specificity of this community.
Detailed description
In recent years, the increased availability of breathing gas mixtures, together with progressive technical development of specialized diving equipment, has contributed to expansion of the diver's community. Deep and long dives expose to decompression sickness (DCS) risk and hyperbaric oxygen therapy (HBO) is the definitive treatment. Incidence, clinical expression or prognosis of pathological events after technical diving might differ from recreational ones. A better knowledge of these specificity will facilitate risk assessment, analysis and medical care for hyperbaric physician community.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Technical divers are defined by specialized equipment (e.g. rebreather) and/or helium based mixed-gases used to conduct deeper and longer dives. All divers who consulted hyperbaric installations after one of these dives with a retained diagnosis of a diving accident are eligible to participate.
Key inclusion criteria (3 listed)
- Civilian technical diver
- Diving accident history (decompression sickness, biochemical accident or immersion pulmonary edema) following a technical dive in a trimix and/or rebreather dive
- Treated in a hyperbaric center on the coast of mainland France
Key exclusion criteria (2 listed)
- Participation denied by the diver
- Diving incident diagnosis not retained by the hyperbaric physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic description of injured technical divers treated in French hyperbaric center
Time frame: 15 years
Comparison of technical diver populations according to length of hospitalization (< 48 hours vs > 48 hours) corresponding to treatment with simple hyperbaric oxygen therapy or requiring several consolidation sessions in view of the severity and/or intensity of symptoms.
1 secondary outcome
Predictive factor of severity
Time frame: 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Emmanuel GOUIN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompression Sickness and Pulmonary Edema - Acute, 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anaïs CAILLARD (0298347240 ext. +33, anais.caillard@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic description of injured technical divers treated in French hyperbaric center (time frame: 15 years). 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 4 Oct 2024.