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Not yet recruitingNCT06627153TEKCareUpdated Oct 4, 2024

Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity (TEKCare)

An observational study in Decompression Sickness, Pulmonary Edema - Acute and Oxygen Toxicity, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Decompression Sickness
  • Pulmonary Edema - Acute
  • Oxygen Toxicity
  • Carbon Dioxide Poisoning
  • Nitrogen Narcosis

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03

In context

Decompression Sickness

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

This study's planned enrollment of 100 is above the median of 74 across 12 observational studies indexed under Decompression Sickness.

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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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

  • 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

Exclusion criteria

Exclusion Criteria:

  • Participation denied by the diver
  • Diving incident diagnosis not retained by the hyperbaric physician
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 15 years

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

Time frame: Data will be available beginning three years and ending fifteen years following the final study report completion

Access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for May 2025, 4 months later.

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

Registered
Sep 23, 2024
First posted
Oct 4, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
May 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Oct 4, 2024
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 Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06627153
Responsible party
Sponsor
First posted
Oct 4, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 4, 2024

Study contacts

Anaïs CAILLARD
Contact
anais.caillard@chu-brest.fr
0298347240 ext. +33
Emmanuel GOUIN
Contact
emmanuel.gouin@univ-brest.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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