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Completed

NCT Number: NCT06270095

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

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.

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Key information

Conditions

Neurologic Symptoms Nervous System Diseases Neurologic Disorder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Air France DP.ZM Service de Santé au travail de Roissy-Charles-de-Gaulle

Roissy CDG, 95700, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • be pregnant
  • be over 67 years of age

Treatment and study plan

Neurocognitive, neuromuscular and neurosensitive tests.

Diagnostic Test

At T0, the subject realizes a neurocognive test and an self-assessment of health symptoms autonomously on its professional digital tablet. They also realizes two self questionnaires on their state of fatigue (Samn-Perelli Fatigue Scale) and anxiety (Hospital Anxiety and Depression scale).

At T0 + 3 months, the subject follows a standardized medical examination carried out by a physician, assessing neuromuscular score using the Medical Research Council questionnaire and assessing neurosensitivity score using the Incat Sensory Sum Score. If necessary, the DN4 questionnaire for neuropathic pain is used. The same neurocognitive tests than T0, and Samn-Perelli Fatigue Scale and Hospital Anxiety and Depression scale are also repeated.

Primary outcomes

  1. Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning

    Time frame: Inclusion and month 3

    Boxes are displayed on the screen and are "opened" in a randomised order. One or more of them will contain a pattern. The patterns are then displayed in the middle of the screen, one at a time and the participant must select the box in which the pattern was originally located.

  2. Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing

    Time frame: Inclusion and month 3

    A white box is shown in the centre of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits. When the participant sees the target sequence they must respond as quickly as possible.

  3. Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge

    Time frame: Inclusion and month 3

    The participant is shown two displays containing three coloured balls. The displays are presented in such a way that they can be easily perceived as stacks of coloured balls held in stockings or socks suspended from a beam. This arrangement makes the 3-D concepts involved apparent to the participant and fits with the verbal instructions.

  4. Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies

    Time frame: At month 3

    Neurosensitive test performed by the doctor during the medical consultation using the Incat Sensory Sum Score (total score: 0-20 with 0: normal sensitivity and 20: very severe sensitivity deficit; each part of the body is graduated from 0: normal sensitivity to 4: very severe sensitivity deficit).

  5. Neuromuscular test to evaluate muscle strength assessment

    Time frame: At month 3

    Neuromuscular test performed by the doctor during the medical consultation using the Medical Research Council questionnaire (total score: 0-60 with 0:.complete tetraplegia and 60: normal muscle strength; each muscular group to a score ranging 0: no visible contraction and 5: normal muscle strength).

  6. Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight

    Time frame: Inclusion and month 3

    Collect of symptoms by self-administered questionnaire on professional electronic tablet

Secondary outcomes

  1. Characteristics of plane and fume event and possible causes of fume event

    Time frame: Inclusion

    Characteristics of plane and fume event recorded by a self-administered questionnaire to the Chief Flight Attendant. the information collected is:

    aeroplane type; aerodrome of departure and arrival; meteorological conditions at take-off and landing; characteristics of the occurrence for flights with fume event (phase of flight during the occurrence, estimated duration, nature of the occurrence, location, potential sources of contamination).

  2. Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.

    Time frame: Inclusion

    Sampling of flight with and without fume event. A short-term (1h) selected organophosphates measurments after all reported fume event on board, by means of a small air sampler operated by flight crew as well as measurements in a similar flight (control) without fume event is carried out during the following week.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • National Agency for Sanitary Safety of the Food of the Environment and Labor
  • Université Paris Cité

Registry information

Official study 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)

Acronym: AVISAN

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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