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

NCT ID: NCT06270095

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2025-04-30

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.

Conditions

Neurologic Symptoms; Neurologic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed

Aircrew exposed to a fume event

Neurocognitive, neuromuscular and neurosensitive tests.

Intervention Type: 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.

Non-exposed

Aircrew not exposed to a fume event but present on a control flight

Neurocognitive, neuromuscular and neurosensitive tests.

Intervention Type: 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.

Interventions

Neurocognitive, neuromuscular and neurosensitive tests.

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Paris Cité

OTHER

Sponsor Role: collaborator

National Agency for Sanitary Safety of the Food of the Environment and Labor

OTHER_GOV

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynda BENSEFA-COLAS

Role: STUDY_DIRECTOR

National Institute of Health and Medical Research

Locations

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

Roissy CDG, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lynda BENSEFA-COLAS

Role: CONTACT

lynda.bensefa-colas@aphp.fr

+33 6 11 74 88 15

Jean-Ulrich MULLOT

Role: CONTACT

jean-ulrich.mullot@intradef.gouv.fr

+33 6 12 55 47 56

Facility Contacts

Michel KLERLEIN

Role: primary

miklerlein@airfrance.fr

0141567070

Other Identifiers

C21-57

Identifier Type: -

Identifier Source: org_study_id