" Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft" (AVISAN)

I

Institut National de la Santé Et de la Recherche Médicale, France

Status

Not yet enrolling

Conditions

Neurologic Disorder
Neurologic Symptoms

Treatments

Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.

Study type

Observational

Funder types

Other

Identifiers

NCT06270095
C21-57

Details and patient eligibility

About

The subject of the study focuses on commercial aircraft's 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.

Full 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 flight's 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 67 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • be of legal age (18 years)
  • have signed the consent form

Exclusion criteria

  • be pregnant
  • be over 67 years of age

Trial design

1,200 participants in 2 patient groups

Exposed
Description:
Aircrew exposed to a fume event
Treatment:
Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.
Non-exposed
Description:
Aircrew not exposed to a fume event but present on a control flight
Treatment:
Diagnostic Test: Neurocognitive, neuromuscular and neurosensitive tests.

Trial contacts and locations

0

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Central trial contact

Jean-Ulrich MULLOT; Lynda BENSEFA-COLAS

Data sourced from clinicaltrials.gov

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