Diver Ear, Nose and Throat Barotrauma Epidemiology

NCT04647591 | Unknown

• 2 other identifiers: 2020PRI072020-A02893-36
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

ENT barotrauma; Epidemiology; Risk factors; Diving; Professional impact; Barotrauma management

Outcome Measures

Primary Outcomes (1)

• ENT Barotrauma incidence among French army divers and student divers followed for 2 years

  Number of ENT barotrauma occurring among French army divers and student divers enrolled in the study for 2 years. Characteristics of concerned divers (diving level, medical history…) will also be presented. ENT Barotrauma events will be defined according to Haines and Harris classification after otoscopic examination for middle ear and by sinus pain sudden onset during diving for sinuses. Clinical confirmation will be obtained through questioning and suggestive disease history. In case of doubt, a scanner will be used.

  4 years

Secondary Outcomes (5)

• Correlation between ENT barotrauma and divers characteristics

  4 years

• ENT barotrauma treatment

  4 years

• ENT barotrauma-induced incapacity periods

  4 years

• ENT barotrauma incidence among student divers followed for one year

  3 years

• ENT barotrauma-induced permanent incapacities

  4 years

Study Arms (1)

ENT Barotrauma incidence and link with risk factors

EXPERIMENTAL

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

ENT Barotrauma incidence and link with risk factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• French military professional diver of French army diver following diving training (this includes navy, land forces, police, air force, army health service)
• year or older man or woman

You may not qualify if:

• Diver opposing his study participation
• Diver who doesn't master enough French language reading or understanding to be able to oppose his study participation
• Every other reason which, according to investigator, might interfere with the assessment of research outcomes
• Diver being part of special forces

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (7)

160e Antenne Médicale d'Antibes

Antibes, Alpes Maritimes, 06606, France

RECRUITING

2nd Groupe Plongeurs Démineurs Brest

Brest, Finistère, 29240, France

RECRUITING

1er Groupe Plongeurs Démineurs Cherbourg

Cherbourg, Manche, 50115, France

RECRUITING

152e Antenne Médicale de St Mandrier

Toulon, Var, 83800, France

RECRUITING

3e Groupe Plongeurs Démineurs Toulon

Toulon, Var, 83800, France

RECRUITING

Base navale de Toulon

Toulon, Var, 83800, France

RECRUITING

Service de médecine hyperbare et expertise de la plongée

Toulon, Var, 83800, France

RECRUITING

Related Publications (2)

• Taylor DM, O'Toole KS, Ryan CM. Experienced scuba divers in Australia and the United States suffer considerable injury and morbidity. Wilderness Environ Med. 2003 Summer;14(2):83-8. doi: 10.1580/1080-6032(2003)014[0083:esdiaa]2.0.co;2.

  PMID: 12825881 BACKGROUND

• Fitzpatrick DT, Franck BA, Mason KT, Shannon SG. Risk factors for symptomatic otic and sinus barotrauma in a multiplace hyperbaric chamber. Undersea Hyperb Med. 1999 Winter;26(4):243-7.

  PMID: 10642071 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean Morin, MD

  Hopital d'Instruction des Armées Sainte Anne

  STUDY DIRECTOR

Central Study Contacts

Jean Morin, MD

CONTACT

04 83 16 23 42; jean.morin@intradef.gouv.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 1, 2020
• Study Start: October 4, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)