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Diver Ear, Nose and Throat Barotrauma Epidemiology

NCT04647591 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-12

No results posted yet for this study

Summary

Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. One study related to recreational diving reports that ENT barotrauma concern 10% of dives with experimented divers and 30% with novice divers. Nevertheless, a low number of studies were realized on ENT barotrauma, particularly those involving middle ear and sinuses, maybe because most of them evolve favorably without sequelae.

Besides, it has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But once again no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence. Few data on military population exist either. However, operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Furthermore, therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption.

The purpose of this research is to study middle ear and sinus barotrauma thanks to questionnaires focused on those pathologies and their potential risk factors. The hypothesis is that it will allow identification of main risk factors in order to develop preventive measures as well as the characteristics and missions of concerned divers and the impact of those barotrauma on this population.

Conditions

  • Barotrauma Epidemiology

Interventions

OTHER

Questionnaires

Use of a questionnaire focused on diver experience and medical history upon inclusion and another questionnaire in case of ENT Barautrauma over a period of two years to standardize Barotrauma assessment.

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Principal Investigators

  • Jean Morin, MD · Hopital d'Instruction des Armées Sainte Anne

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647591 on ClinicalTrials.gov