Clinical trial NCT06270095: " Fume Events in Air Flights: Consequences on Cabin Air Quality and on Aircrews Health of a French Fleet of Aircraft"
Official title: " Évènements Feux/Fumées/Odeurs Lors Des Vols aériens : conséquences Sur la qualité de l'Air à l'intérieur Des Cabines d'Avions et Sur la santé Des Personnels Navigants d'Une Flotte aérienne française " (AviSan)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurologic Symptoms
Neurologic Disorder
Keywords: Fume events
Aircrew
Air quality
Organophosphorus compounds
Occupational exposure
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Université Paris Cité
name: National Agency for Sanitary Safety of the Food of the Environment and Labor
First posted: 2024-02-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy aircrew population of a French airline exposed with (exposed) and whithout (non-exposed) fume events.

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* be pregnant
* be over 67 years of age

Primary outcomes:
measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning
timeFrame: Inclusion and month 3
measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing
timeFrame: Inclusion and month 3
measure: Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge
timeFrame: Inclusion and month 3
measure: Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies
timeFrame: At month 3
measure: Neuromuscular test to evaluate muscle strength assessment
timeFrame: At month 3
measure: Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight
timeFrame: Inclusion and month 3
Secondary outcomes:
measure: Characteristics of plane and fume event and possible causes of fume event
timeFrame: Inclusion
measure: Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.
timeFrame: Inclusion
Other outcomes:
Locations:
city: Roissy CDG
country: France
facility: Air France DP.ZM Service de Santé au travail de Roissy-Charles-de-Gaulle
Study officials:
affiliation: National Institute of Health and Medical Research
name: Lynda BENSEFA-COLAS
role: STUDY_DIRECTOR
References: