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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Decompression Sickness; Oxygen Toxicity; Pulmonary Edema - Acute; Nitrogen Narcosis; Carbon Dioxide Poisoning

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anaïs CAILLARD; Phone Number: +33 0298347240; Email: anais.caillard@chu-brest.fr
• Study Contact Backup: Name: Emmanuel GOUIN; Email: emmanuel.gouin@univ-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Chu Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Occupational Diseases; Gas Poisoning; Barotrauma; Poisoning; Pulmonary Edema; Decompression Sickness; Inert Gas Narcosis
• Other Study ID Numbers: 29BRC24.0150 - TEKCare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No