Diver Ear, Nose and Throat Barotrauma Epidemiology (BTORL PAF)
Primary Purpose
Barotrauma Epidemiology
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional screening trial for Barotrauma Epidemiology focused on measuring ENT barotrauma, Epidemiology, Risk factors, Diving, Professional impact, Barotrauma management
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
Sites / Locations
- 160e Antenne Médicale d'AntibesRecruiting
- 2nd Groupe Plongeurs Démineurs BrestRecruiting
- 1er Groupe Plongeurs Démineurs CherbourgRecruiting
- 152e Antenne Médicale de St MandrierRecruiting
- 3e Groupe Plongeurs Démineurs ToulonRecruiting
- Base navale de ToulonRecruiting
- Service de médecine hyperbare et expertise de la plongéeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ENT Barotrauma incidence and link with risk factors
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
ENT barotrauma treatment
Treatments prescribed for ENT barotrauma will be presented.
ENT barotrauma-induced incapacity periods
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
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
Number of permanent incapacities induced by ENT barotrauma will be presented.
Full Information
NCT ID
NCT04647591
First Posted
October 23, 2020
Last Updated
October 5, 2021
Sponsor
Direction Centrale du Service de Santé des Armées
1. Study Identification
Unique Protocol Identification Number
NCT04647591
Brief Title
Diver Ear, Nose and Throat Barotrauma Epidemiology
Acronym
BTORL PAF
Official Title
ENT Barotrauma Epidemiology Among French Army Divers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barotrauma Epidemiology
Keywords
ENT barotrauma, Epidemiology, Risk factors, Diving, Professional impact, Barotrauma management
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ENT Barotrauma incidence and link with risk factors
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
ENT Barotrauma incidence among French army divers and student divers followed for 2 years
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Correlation between ENT barotrauma and divers characteristics
Description
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
Time Frame
4 years
Title
ENT barotrauma treatment
Description
Treatments prescribed for ENT barotrauma will be presented.
Time Frame
4 years
Title
ENT barotrauma-induced incapacity periods
Description
Duration of incapacity periods that will be prescribed after ENT barotrauma events will be presented.
Time Frame
4 years
Title
ENT barotrauma incidence among student divers followed for one year
Description
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.
Time Frame
3 years
Title
ENT barotrauma-induced permanent incapacities
Description
Number of permanent incapacities induced by ENT barotrauma will be presented.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Morin, MD
Phone
04 83 16 23 42
Ext
+33
Email
jean.morin@intradef.gouv.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Morin, MD
Organizational Affiliation
Hopital d'Instruction des Armées Sainte Anne
Official's Role
Study Director
Facility Information:
Facility Name
160e Antenne Médicale d'Antibes
City
Antibes
State/Province
Alpes Maritimes
ZIP/Postal Code
06606
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Rouquette
Phone
0492907236
Ext
+33
Email
dominique.rouquette@intradef.gouv.fr
Facility Name
2nd Groupe Plongeurs Démineurs Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Riesemann
Phone
0233929680
Ext
+33
Email
nicolas.riesemann@intradef.gouv.fr
Facility Name
1er Groupe Plongeurs Démineurs Cherbourg
City
Cherbourg
State/Province
Manche
ZIP/Postal Code
50115
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didier Routelous
Phone
0298229589
Ext
+33
Email
didier.routelous@intradef.gouv.fr
Facility Name
152e Antenne Médicale de St Mandrier
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien De Maistre
Phone
0422428345
Ext
+33
Email
Sebastien.demaistre@intradef.gouv.fr
Facility Name
3e Groupe Plongeurs Démineurs Toulon
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric Bergmann
Phone
0422423930
Ext
+33
Email
cedric.bergmann@intradef.gouv.fr
Facility Name
Base navale de Toulon
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarie Curet
Phone
0422420479
Ext
+33
Email
clarie.curet@intradef.gouv.fr
Facility Name
Service de médecine hyperbare et expertise de la plongée
City
Toulon
State/Province
Var
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Morin, MD
Phone
0483162342
Ext
+33
Email
jean.morin@intradef.gouv.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12825881
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.
Results Reference
background
PubMed Identifier
10642071
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.
Results Reference
background
Links:
URL
https://www.editions-ellipses.fr/accueil/2064-physiologie-et-medecine-de-la-plongee-9782729829834.html
Description
Related Info
Learn more about this trial
Diver Ear, Nose and Throat Barotrauma Epidemiology
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