Diver Ear, Nose and Throat Barotrauma Epidemiology (BTORL PAF)
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| ClinicalTrials.gov Identifier: NCT04647591 |
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Recruitment Status :
Recruiting
First Posted : December 1, 2020
Last Update Posted : October 12, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Barotrauma Epidemiology | Other: Questionnaires | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | ENT Barotrauma Epidemiology Among French Army Divers |
| Actual Study Start Date : | October 4, 2021 |
| Estimated Primary Completion Date : | October 2024 |
| Estimated Study Completion Date : | October 2024 |
| 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. |
- ENT Barotrauma incidence among French army divers and student divers followed for 2 years [ Time Frame: 4 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.
- Correlation between ENT barotrauma and divers characteristics [ Time Frame: 4 years ]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
- ENT barotrauma treatment [ Time Frame: 4 years ]Treatments prescribed for ENT barotrauma will be presented.
- ENT barotrauma-induced incapacity periods [ Time Frame: 4 years ]Duration of incapacity periods that will be prescribed after ENT barotrauma events will be presented.
- ENT barotrauma incidence among student divers followed for one year [ Time Frame: 3 years ]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.
- ENT barotrauma-induced permanent incapacities [ Time Frame: 4 years ]Number of permanent incapacities induced by ENT barotrauma will be presented.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647591
| Contact: Jean Morin, MD | 04 83 16 23 42 ext +33 | jean.morin@intradef.gouv.fr |
| France | |
| 160e Antenne Médicale d'Antibes | Recruiting |
| Antibes, Alpes Maritimes, France, 06606 | |
| Contact: Dominique Rouquette 0492907236 ext +33 dominique.rouquette@intradef.gouv.fr | |
| 2nd Groupe Plongeurs Démineurs Brest | Recruiting |
| Brest, Finistère, France, 29240 | |
| Contact: Nicolas Riesemann 0233929680 ext +33 nicolas.riesemann@intradef.gouv.fr | |
| 1er Groupe Plongeurs Démineurs Cherbourg | Recruiting |
| Cherbourg, Manche, France, 50115 | |
| Contact: Didier Routelous 0298229589 ext +33 didier.routelous@intradef.gouv.fr | |
| 152e Antenne Médicale de St Mandrier | Recruiting |
| Toulon, Var, France, 83800 | |
| Contact: Sébastien De Maistre 0422428345 ext +33 Sebastien.demaistre@intradef.gouv.fr | |
| 3e Groupe Plongeurs Démineurs Toulon | Recruiting |
| Toulon, Var, France, 83800 | |
| Contact: Cédric Bergmann 0422423930 ext +33 cedric.bergmann@intradef.gouv.fr | |
| Base navale de Toulon | Recruiting |
| Toulon, Var, France, 83800 | |
| Contact: Clarie Curet 0422420479 ext +33 clarie.curet@intradef.gouv.fr | |
| Service de médecine hyperbare et expertise de la plongée | Recruiting |
| Toulon, Var, France, 83800 | |
| Contact: Jean Morin, MD 0483162342 ext +33 jean.morin@intradef.gouv.fr | |
| Study Director: | Jean Morin, MD | Hopital d'Instruction des Armées Sainte Anne |
Publications:
| Responsible Party: | Direction Centrale du Service de Santé des Armées |
| ClinicalTrials.gov Identifier: | NCT04647591 |
| Other Study ID Numbers: |
2020PRI07 2020-A02893-36 ( Other Identifier: Id-RCB ) |
| First Posted: | December 1, 2020 Key Record Dates |
| Last Update Posted: | October 12, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Barotrauma Wounds and Injuries |