Respiratory Function Clinical Trial
Official title:
Nanoparticles Emitted by Aircraft Engines, Impact on Respiratory Function
The goal of this study is to assess the respiratory health of the Air France company's employees working in the Marseilles and Paris airports (flight line and administrative employees). This study was promoted by the Montpellier CHRU, Regional University Hospital Centre (ANSM identification number 2011-A00646-35). It allowes voluntary employees to be involved. They answer a lifestyle survey and perform a spirometry, an exhaled CO measurement and a sampling of exhaled air condensate (EAC). A metrological study of particles emitted by aircraft engines and found in the airport environment will be conducted and the elementary chemical composition analysis, as well a sieve analysis of particles present in the EAC will be conducted.
Air traffic is increasing, raising concern about local pollution and its adverse health
effects on the people living in the vicinity of large airports. However, the highest risk is
probably occupational exposure due to proximity. Jet exhaust is one of the main concerns at
an airport and may have a health impact, particularly on the respiratory tract. Current
studies are neither numerous enough nor strong enough to prove this kind of association.
Yet, more and more people work in airports, and occupational exposure to jet exhaust is a
fact. In 1999, the effect of occupational exposure to aircraft fuel and jet exhaust on
pulmonary function and respiratory symptoms in Birmingham International Airport (Birmingham,
UK) workers was reported. This work suggested that there was a link between high
occupational exposure to aviation fuel or jet exhaust and excess respiratory tract symptoms,
consistent with the presence of a respiratory irritant. It was a cross-sectional survey
using a questionnaire filled out by the participants themselves. Respiratory and
immunological function assessments and an exhaled carbon monoxide measurement were conducted
with male full-time airport workers classified into three groups according to their exposure
level.
The study will be presented to the volunteering subjects during an occupational medical
appointment concerning their company. The information letter will be provided as well as the
informed consent form to be filled for the study. Once the subjects have agreed to
participate, self-surveys on their lifestyle habits will be filled and EACand urine
samplings will be taken during one same consultation, in addition to exhaled CO and No
measurements. This consultation will also include a spirometry test. The employees'
workstation data will be collected. Therefore, the volunteers' participation is limited to
one single visit including non-invasive examinations and self-surveys.
Method details:
- Survey: The survey breaks down into 2 parts, with a total of 94 items. The first part
bears on the employees' respiratory health condition, essentially grounded on the
validated EGEA survey. The rest focuses on employees' lifestyle habits, both
professionally (outdoor and indoor working time, trade, type of exposure, etc.) and
personally (geographical situation of the home, type of town or community, heating
system, usual mode of cooking, etc.). The survey is anonymised and the answers are
automatically read by datascan process.
- Spirometry: This method allows a non-invasive, simple and repeatable assessment of the
respiratory function. It is indispensable to clearly explain the process to the
patient. The patient sits with his or her back straight during the process. Once the
subject and the device are ready, the subject deeply breathes in to fill the lungs then
fully expires into the spirometer. Then the subject breathes in fully and forcedly in
order to obtain the inspiratory curve. The spirometry results are compared with
theoretical or predicted values determined based on patient's age, gender, size and
ethnic group. Consequently, according to the subject's breathing speed and force
intensity, measurements of vital capacity (VC) or forced vital capacity (FVC) are
obtained. The curves will allow the other variables to be deduced, such as maximum
expiratory volume per second (MEVS) or peak expiratory flow (PEF), or mean expiratory
flows (MEF 25-75).
- Exhaled CO measurement (confounding factors of the respiratory function, in order to
reflect the smoking status):the employee blows into the device's single-use cardboard
mouthpiece after a deep inspiration followed by a fifteen-second apnea computed by the
device. The measurement in part per million (ppm) is immediately displayed on the
device to quantify the severity of CO intoxication. This measurement is simple and
repeatable.
- Exhaled air condensate:for EAC acquisition. In fact, the RTube device is well adapted
to non-invasion collection on the companies' sites. It will be used according to the
recommendations from the American Thoracic Society and the EuropeanRespiratory Society.
The R tube will be pre-treated as in the first study (intensive washing in order to
abate background noise) and "white" R tubeswill be collected all through the study to
check the method's detection limit. Briefly, the collection with nose blocked lasts for
15 minutes during which the subject breathes normally through the device. The mouth is
rinsed with water before collection and the subject is asked to refrain from drinking
or eating during the previous hour. This will allow ca. 1.4 ml to be collected (mean
EACvolume collected during the first study over a 15-minute breathing time).
- Metrology:as this is a recent subject, there is no consensus so far on the most
representative unit of measurement for employee exposure. Similarly, no current device
allows all parameters to be obtained:quantitative data (particle content/cm3, sieve
distribution, developed surface area of the alveolar fraction likely to be exposed in
the breathing apparatus) and qualitative data (morphology, aggregation/agglomeration
status, listof constitutive chemical elements). These experts' surveys require the
implementation of different equipment. The method is based on personal metrology, use
of portable and individual systems, as well as fixed installation metrology, organised
into a single sampling by means of a cane to which the various measuring instruments
are connected (Condensation ParticleCounter, ElectrostaticLow Pressure Impactor,
Scanning MobilityParticleSizer, FastMobilityParticleSizer, Nanometer Surface Area
Monitor, Alveolar Sensor, Alveolar Inhalable Thoracic sensor).An independent counter
(Condensation ParticleCounter) allows background evolution to be monitored. Membrane
sensors (such as the Giliansampling pump with membrane support) will also complement
the process. They will be used as portable systems, on the employees involved in the
study. Finally, the samples will be analysed by means of a SEM (Scanning Electron
Microscope),model 5500 from Hitachi, associated with an energy-dispersive EDX system (X
analysis system - Noranmodel from the Thermocompany).
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