PASSIVE SMOKING , Clinical Trial
Official title:
Effects Of Passive Smoking On The Respiratory System Mechanics Of Healthy Non-Smokers In Different Body Positions
The study will examine changes in the respiratory system mechanics and in respiratory
physiology after exposure of subjects to passive smoking. It is about healthy non-smoking
volunteers and it will be carried out through the techniques of forced oscillation with
Impulse Oscillometry (IOS) technique methodology and nitrogen washout.
The present study will contribute to the understanding of passive smoking consequences on
the respiratory system of healthy non-smokers. Thanks to the nitrogen washout technique,
changes to closing volume and closing capacity will be examined during measurement in
different positions (sitting, decubitus) together with exposure to passive smoking. With IOS
methodology, changes in respiratory system resistance in four positions (standing, sitting,
right and left lateral decubitus) will be evaluated before and after exposure to a passive
smoking environment. Results of the present study are expected to provide interesting
information on the changes in measured parameters not only in different positions but also
after exposure to smoking.
Methodology
For the current study the following techniques will be used. Impulse Oscillometry (IOS)
methodology constitutes a method of studying the respiratory system mechanics, during which
the investigators manage to determine the flow resistance, the capacity resistance and the
resonant frequency through the application of multifrequent signals. It also offers the
possibility of studying the mechanics of central and peripheral respiratory system.
The nitrogen washout technique is a method of indirect measurement of the functional
residual capacity, during which exhaled nitrogen is measured after the subject has breathed
oxygen of a 100% density. A single breath nitrogen washout contributes to the measurement of
closing volume and closing capacity.
Emitted particles, detected in a smoking environment, will be measured with the SIDEPAK
AM510, which is a measurement device of particles based on their diameter.
The research will be conducted according to the following procedure. Healthy non-smoking
volunteers (18-40 years old) will be subject, after giving their brief medical history, to
IOS and to the nitrogen washout test. The IOS will be conducted in four positions (standing,
sitting, right and left lateral decubitus), whereas the nitrogen washout test in two
(sitting and decubitus).
Then the subject will be exposed to a smoking environment for 20 minutes, under a continuous
measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed
space of 20 m3. The passive smoking environment will be achieved via a smoking machine.
Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right
and left lateral decubitus) and nitrogen washout test in two positions (sitting and
decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be
evaluated.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention