Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-12-27
Brief Title:
Fume Events in Air Flights Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Évènements FeuxFuméesOdeurs Lors Des Vols aériens conséquences Sur la qualité de lAir à lintérieur Des Cabines dAvions et Sur la santé Des Personnels Navigants dUne Flotte aérienne française AviSan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
AVISAN
Brief Summary:
The subject of the study focuses on commercial aircrafts cabins air quality under conditions of both fume events and non-fume events It also delves into the immediate and delayed repercussions of these events on the health of aviation crew members The expological facet of this study is directed at the detection and quantification of organophosphorus compounds originating from engine oils The epidemiological facet is geared towards the identification of potential neurological consequences
Detailed Description:
The study has two components one in the field of expology and the other in epidemiology
The first part will involve instantaneous atmospheric measurement of organophosphorus additives in oils namely TCP isomers TXP isomers commercially available and TBP during any fume event using a portable device developed for this type of event pre-positioned on all aircraft over a short time span around 1 h
An identical measurement campaign will be systematically carried out on a control flight free of fume event within a week The aim of this experiment is to sample all fume event around 100 occurring over a period of 12 months and as many fume event free flights
At the same time carbon monoxide will be measured along with organophosphates during the event
In parallel with these measurements a flight self-questionnaire will be compiled on flight characteristics and cabin environmental conditions will be completed by the flights in-charge
The second epidemiological phase will take place in two stages Each measurement whether or not it concerns event or not will be coupled with a systematic self-questionnaire collection of symptoms experienced during the flight reported by exposed and non-exposed flight crews
T0 no later than 72 hours after the end of the flight
In addition in order to identify acute and delayed neurological impairment and to assess cognitive functions each subject included exposed and unexposed will perform
A self-assessment within 72 hours Phase 1 and 3 months later Phase 2 of their neurocognitive performance using the CANTAB Cambridge Neuropsychological Test Automated Battery coupled with a self-assessment of fatigue and anxiety levels using self-questionnaires
A medical consultation 3 months later Phase 2 including a standardized medical check-up with neuromuscular and neurosensory tests self-questionnaires and neurocognitive evaluation identical to those used in Phase 1
Phase 2 is carried out three months after exposure in order to investigate effects with a latency up to 5 weeks after exposure
The first part will involve instantaneous atmospheric measurement of organophosphorus additives in oils namely TCP isomers TXP isomers commercially available and TBP during any fume event using a portable device developed for this type of event pre-positioned on all aircraft over a short time span around 1 h
An identical measurement campaign will be systematically carried out on a control flight free of fume event within a week The aim of this experiment is to sample all fume event around 100 occurring over a period of 12 months and as many fume event free flights
At the same time carbon monoxide will be measured along with organophosphates during the event
In parallel with these measurements a flight self-questionnaire will be compiled on flight characteristics and cabin environmental conditions will be completed by the flights in-charge
The second epidemiological phase will take place in two stages Each measurement whether or not it concerns event or not will be coupled with a systematic self-questionnaire collection of symptoms experienced during the flight reported by exposed and non-exposed flight crews
T0 no later than 72 hours after the end of the flight
In addition in order to identify acute and delayed neurological impairment and to assess cognitive functions each subject included exposed and unexposed will perform
A self-assessment within 72 hours Phase 1 and 3 months later Phase 2 of their neurocognitive performance using the CANTAB Cambridge Neuropsychological Test Automated Battery coupled with a self-assessment of fatigue and anxiety levels using self-questionnaires
A medical consultation 3 months later Phase 2 including a standardized medical check-up with neuromuscular and neurosensory tests self-questionnaires and neurocognitive evaluation identical to those used in Phase 1
Phase 2 is carried out three months after exposure in order to investigate effects with a latency up to 5 weeks after exposure
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