" 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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 357
- 试验地点
- 2
- 主要终点
- Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be of legal age (18 years)
- •have signed the consent form
排除标准
- •be pregnant
- •be over 67 years of age
研究组 & 干预措施
Exposed
Aircrew exposed to a fume event
干预措施: Neurocognitive, neuromuscular and neurosensitive tests. (Diagnostic Test)
Non-exposed
Aircrew not exposed to a fume event but present on a control flight
干预措施: Neurocognitive, neuromuscular and neurosensitive tests. (Diagnostic Test)
结局指标
主要结局
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Paired Associates Learning
时间窗: 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.
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: Rapid Visual Information Processing
时间窗: 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.
Neurosensitive test to explore superficial and deep sensitivity deficits in peripheral neuropathies
时间窗: 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).
Neuromuscular test to evaluate muscle strength assessment
时间窗: 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).
Symptoms experienced during the flight or within 72 hours after the flight, duration of symptoms, symptoms experienced previously outside the flight
时间窗: Inclusion and month 3
Collect of symptoms by self-administered questionnaire on professional electronic tablet
Neurocognitive self-assessment tests on digital tablet - CANTAB test battery: One Touch Stockings of Cambridge
时间窗: 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.
次要结局
- Characteristics of plane and fume event and possible causes of fume event(Inclusion)
- Measurement of organophosphorus and carbon monoxide in cabin air using an air sampler and a piston syringe.(Inclusion)