Barotrauma Epidemiology Clinical Trial
— BTORL PAFOfficial title:
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | October 2024 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 160e Antenne Médicale d'Antibes | Antibes | Alpes Maritimes |
| France | 2nd Groupe Plongeurs Démineurs Brest | Brest | Finistère |
| France | 1er Groupe Plongeurs Démineurs Cherbourg | Cherbourg | Manche |
| France | 152e Antenne Médicale de St Mandrier | Toulon | Var |
| France | 3e Groupe Plongeurs Démineurs Toulon | Toulon | Var |
| France | Base navale de Toulon | Toulon | Var |
| France | Service de médecine hyperbare et expertise de la plongée | Toulon | Var |
| Lead Sponsor | Collaborator |
|---|---|
| Direction Centrale du Service de Santé des Armées |
France,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | ENT barotrauma treatment | Treatments prescribed for ENT barotrauma will be presented. | 4 years | |
| Secondary | ENT barotrauma-induced incapacity periods | Duration of incapacity periods that will be prescribed after ENT barotrauma events will be presented. | 4 years | |
| Secondary | 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 | |
| Secondary | ENT barotrauma-induced permanent incapacities | Number of permanent incapacities induced by ENT barotrauma will be presented. | 4 years |