Diver Ear, Nose and Throat Barotrauma Epidemiology (BTORL PAF)

ENT Barotrauma Epidemiology Among French Army Divers

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.

Study Overview

• Status: Recruiting
• Conditions: Barotrauma Epidemiology
• Intervention / Treatment: Other: Questionnaires

Detailed Description

Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. 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 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.

Futhermore, few data on military population exist while 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. 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 aim of this research is then to study middle ear and sinus barotrauma in order to identify main risk factors, the characteristics and missions of concerned military divers and the impact of those pathologies on this population. Two kind of questionnaires will be used : one which will be completed by divers just after their inclusion in the study and one that will be filled in case of ENT barotrauma suspicion over a period of two years. The first questionnaire will give information about diving level and medical history and the second one will allow standardized assessment of barotrauma suspicion . Divers will be followed for two years, whether they experience an ENT barotrauma or not.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Morin, MD; Phone Number: +33 04 83 16 23 42; Email: jean.morin@intradef.gouv.fr

Study Locations

• France
  • Alpes Maritimes
    • Antibes, Alpes Maritimes, France, 06606
      • Recruiting
      • 160e Antenne Médicale d'Antibes
      • Contact: Dominique Rouquette; Phone Number: +33 0492907236; Email: dominique.rouquette@intradef.gouv.fr
  • Finistère
    • Brest, Finistère, France, 29240
      • Recruiting
      • 2nd Groupe Plongeurs Démineurs Brest
      • Contact: Nicolas Riesemann; Phone Number: +33 0233929680; Email: nicolas.riesemann@intradef.gouv.fr
  • Manche
    • Cherbourg, Manche, France, 50115
      • Recruiting
      • 1er Groupe Plongeurs Démineurs Cherbourg
      • Contact: Didier Routelous; Phone Number: +33 0298229589; Email: didier.routelous@intradef.gouv.fr
  • Var
    • Toulon, Var, France, 83800
      • Recruiting
      • 152e Antenne Médicale de St Mandrier
      • Contact: Sébastien De Maistre; Phone Number: +33 0422428345; Email: Sebastien.demaistre@intradef.gouv.fr
    • Toulon, Var, France, 83800
      • Recruiting
      • 3e Groupe Plongeurs Démineurs Toulon
      • Contact: Cédric Bergmann; Phone Number: +33 0422423930; Email: cedric.bergmann@intradef.gouv.fr
    • Toulon, Var, France, 83800
      • Recruiting
      • Base navale de Toulon
      • Contact: Clarie Curet; Phone Number: +33 0422420479; Email: clarie.curet@intradef.gouv.fr
    • Toulon, Var, France, 83800
      • Recruiting
      • Service de médecine hyperbare et expertise de la plongée
      • Contact: Jean Morin, MD; Phone Number: +33 0483162342; Email: jean.morin@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENT Barotrauma incidence and link with risk factors	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between ENT barotrauma and divers characteristics	Correlation will be performed between ENT events and characteristics of enrolled divers (diving level, dive kind, medical history…) to determine if one these characteristics constitutes a risk factor	4 years
ENT barotrauma treatment	Treatments prescribed for ENT barotrauma will be presented.	4 years
ENT barotrauma-induced incapacity periods	Duration of incapacity periods that will be prescribed after ENT barotrauma events will be presented.	4 years
ENT barotrauma incidence among student divers followed for one year	Number of ENT barotrauma occurring among French army student divers enrolled in the study and followed for 1 year. Characteristics of concerned student 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.	3 years
ENT barotrauma-induced permanent incapacities	Number of permanent incapacities induced by ENT barotrauma will be presented.	4 years

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Investigators: Study Director: Jean Morin, MD, Hôpital d'Instruction des Armées Sainte Anne

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Epidemiology; Risk factors; ENT barotrauma; Diving; Professional impact; Barotrauma management
• Additional Relevant MeSH Terms: Wounds and Injuries; Barotrauma
• Other Study ID Numbers: 2020PRI07; 2020-A02893-36 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No