Clinical trial NCT04647591: Diver Ear, Nose and Throat Barotrauma Epidemiology
Official title: ENT Barotrauma Epidemiology Among French Army Divers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barotrauma Epidemiology
Keywords: ENT barotrauma
Epidemiology
Risk factors
Diving
Professional impact
Barotrauma management
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ENT Barotrauma incidence among French army divers and student divers followed for 2 years
timeFrame: 4 years
Secondary outcomes:
measure: Correlation between ENT barotrauma and divers characteristics
timeFrame: 4 years
measure: ENT barotrauma treatment
timeFrame: 4 years
measure: ENT barotrauma-induced incapacity periods
timeFrame: 4 years
measure: ENT barotrauma incidence among student divers followed for one year
timeFrame: 3 years
measure: ENT barotrauma-induced permanent incapacities
timeFrame: 4 years
Other outcomes:
Locations:
city: Antibes
country: France
facility: 160e Antenne Médicale d'Antibes
state: Alpes Maritimes
city: Brest
country: France
facility: 2nd Groupe Plongeurs Démineurs Brest
state: Finistère
city: Cherbourg
country: France
facility: 1er Groupe Plongeurs Démineurs Cherbourg
state: Manche
city: Toulon
country: France
facility: 152e Antenne Médicale de St Mandrier
state: Var
city: Toulon
country: France
facility: 3e Groupe Plongeurs Démineurs Toulon
state: Var
city: Toulon
country: France
facility: Base navale de Toulon
state: Var
city: Toulon
country: France
facility: Service de médecine hyperbare et expertise de la plongée
state: Var
Study officials:
affiliation: Hopital d'Instruction des Armées Sainte Anne
name: Jean Morin, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.