Barotrauma EpidemiologyBTORL PAFNCT04647591
Diver Ear, Nose and Throat Barotrauma Epidemiology
A study testing Questionnaires in people with Barotrauma Epidemiology, run by Direction Centrale du Service de Santé des Armées at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barotrauma Epidemiology
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Oct 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
160e Antenne Médicale d'Antibes
Antibes, Alpes Maritimes, 06606
Dominique Rouquette, 0492907236 ext. +33, dominique.rouquette@intradef.gouv.fr
- Recruiting
2nd Groupe Plongeurs Démineurs Brest
Brest, Finistère, 29240
Nicolas Riesemann, 0233929680 ext. +33, nicolas.riesemann@intradef.gouv.fr
- Recruiting
1er Groupe Plongeurs Démineurs Cherbourg
Cherbourg, Manche, 50115
Didier Routelous, 0298229589 ext. +33, didier.routelous@intradef.gouv.fr
- Recruiting
152e Antenne Médicale de St Mandrier
Toulon, Var, 83800
Sébastien De Maistre, 0422428345 ext. +33, Sebastien.demaistre@intradef.gouv.fr
- Recruiting
3e Groupe Plongeurs Démineurs Toulon
Toulon, Var, 83800
Cédric Bergmann, 0422423930 ext. +33, cedric.bergmann@intradef.gouv.fr
- Recruiting
Base navale de Toulon
Toulon, Var, 83800
Clarie Curet, 0422420479 ext. +33, clarie.curet@intradef.gouv.fr
- Recruiting
Service de médecine hyperbare et expertise de la plongée
Toulon, Var, 83800
Jean Morin, MD, 0483162342 ext. +33, jean.morin@intradef.gouv.fr
About this study
Official 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.
Read the 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.
- Conditions
- Barotrauma Epidemiology
- Being tested
- Questionnaires
- Keywords
- ENT barotrauma, Epidemiology, Risk factors, Diving, Professional impact, Barotrauma management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ENT Barotrauma incidence and link with risk factors | Experimental | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (5)
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
Measured: 4 years
ENT barotrauma treatment
Treatments prescribed for ENT barotrauma will be presented.
Measured: 4 years
ENT barotrauma-induced incapacity periods
Duration of incapacity periods that will be prescribed after ENT barotrauma events will be presented.
Measured: 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.
Measured: 3 years
ENT barotrauma-induced permanent incapacities
Number of permanent incapacities induced by ENT barotrauma will be presented.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Oct 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Barotrauma EpidemiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Morin, MD, Study director, Hopital d'Instruction des Armées Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647591
- Sponsor's protocol ID
- 2020PRI07
- Other IDs
- 2020-A02893-36
- Acronym
- BTORL PAF
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1580/1080-6032(2003)014[0083:esdiaa]2.0.co;2.
PubMed 12825881Fitzpatrick 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.
PubMed 10642071
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENT Barotrauma Epidemiology Among French Army Divers
- ClinicalTrials.gov ID
- NCT04647591
- Acronym / sponsor ID
- BTORL PAF / 2020PRI07
- Conditions
- Barotrauma Epidemiology
- Keywords
- ENT barotrauma, Epidemiology, Risk factors, Diving, Professional impact, Barotrauma management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENT Barotrauma incidence and link with risk factors | Experimental | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesUse 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. | Other | ENT Barotrauma incidence and link with risk factors |
Primary outcome
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.
5 secondary outcomes
Correlation between ENT barotrauma and divers characteristics
Time frame: 4 years
ENT barotrauma treatment
Time frame: 4 years
ENT barotrauma-induced incapacity periods
Time frame: 4 years
ENT barotrauma incidence among student divers followed for one year
Time frame: 3 years
ENT barotrauma-induced permanent incapacities
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 12825881Taylor 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.
- Background: PubMed 10642071Fitzpatrick 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Morin, MD study director
Hopital d'Instruction des Armées Sainte Anne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Barotrauma Epidemiology, run by Direction Centrale du Service de Santé des Armées at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Morin, MD (04 83 16 23 42 ext. +33, jean.morin@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ENT Barotrauma incidence among French army divers and student divers followed for 2 years (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647591, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.