Effects Of Passive Smoking On The Respiratory System Mechanics Of Healthy Non-Smokers In Different Body Positions

NCT02171871 | Completed Phase 1 DMC

• 1 other identifier: PBCS003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PASSIVE SMOKING ,; RESPIRATORY SYSTEM MECHANICS,

Keywords

EFFECTS,; PASSIVE SMOKING ,; RESPIRATORY SYSTEM MECHANICS,; DIFFERENT BODY POSITIONS.

Outcome Measures

Primary Outcomes (1)

• change of IOS in four positions (standing, sitting, right and left lateral decubitus)

  IOS methodology constitutes a method of studying the respiratory system mechanics, during which we 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.

  before exposure (Baseline) and after exposure to passive smoking with a 5 minutes interval at one time point

Study Arms (1)

CONTROL GROUP

EXPERIMENTAL

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 subjects will be exposed to a smoking environment for 20 minutes.

Other: exposed to a smoking environment

Interventions

exposed to a smoking environment OTHER

Then the subjects 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.

Also known as: EFFECTS OF PASSIVE SMOKING, RESPIRATORY SYSTEM MECHANICS

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteer, adults, non-smokers

You may not qualify if:

• \< 18 years old , Current pregnancy, Breastfeeding women.

Sponsors & Collaborators

• Hellenic Anticancer Society: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Hellenic Anticancer Society

Athens, Attica, Greece

Location

Related Publications (2)

• Behrakis PK, Baydur A, Jaeger MJ, Milic-Emili J. Lung mechanics in sitting and horizontal body positions. Chest. 1983 Apr;83(4):643-6. doi: 10.1378/chest.83.4.643.

  PMID: 6831953 BACKGROUND

• Stathopoulou H , Vardavas C, Matsunaga Y , Kairi O , Anagnostopoulos N, Karras P , Agaku I, Loukopoulou A, Tzwrtzi A, Behrakis P. The effect of body position during short term exposure to secondhand smoke on pulmonary resistance and impedance using impulse osscilometry European Conference on Tobacco or Health, Istanbul. March 2014

  RESULT

Study Officials

• Panagiotis K Behrakis, Professor

  Hellenic Anticancer Society

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

GR (1)