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

NCT06627153 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0150 - TEKCare
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  15 years

Secondary Outcomes (1)

• Predictive factor of severity

  15 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Decompression Sickness; Inert Gas Narcosis

Condition Hierarchy (Ancestors)

Barotrauma; Wounds and Injuries; Occupational Diseases; Gas Poisoning; Poisoning; Chemically-Induced Disorders

Central Study Contacts

Anaïs CAILLARD

CONTACT

0298347240; anais.caillard@chu-brest.fr

Emmanuel GOUIN

CONTACT

emmanuel.gouin@univ-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 4, 2024
• Study Start: January 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

FR (1)