Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647591
Status:
UNKNOWN
Last Update Posted:
2021-10-12
First Post:
2020-10-23
Brief Title:
Diver Ear Nose and Throat Barotrauma Epidemiology
Sponsor:
Direction Centrale du Service de Santé des Armées
Organization:
Direction Centrale du Service de Santé des Armées
Study Overview
Official Title:
ENT Barotrauma Epidemiology Among French Army Divers
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BTORL PAF
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A02893-36 | OTHER | Id-RCB | None |