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The Protective Role of the Nose During Acute Exposure to Passive Smoking.

13 november 2013 bijgewerkt door: Hellenic Anticancer Society
The aim of this study was to compare the acute effects of second hand smoke exposure between nasal and oral breathing and to assess the potential protective role of the nose during acute exposure, in exposure conditions similar to those within a bar where smoking is permitted.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

Analysis of the laboratory testing:

The measurement of NO for the respiratory tract was performed with a Ecomedics CLD 88spNO analyzer as follows: the examinee performed tidal breathing with a closed nose, through a special mouthpiece and then took a deep breath and exhale steadily with a flow of 50ml/sec. After 3 attempts, during which we obtained an exhaled NO measurement each time, until we obtained a reliability index CV <10%.

For the oscillometry (IOS) of the respiratory tract the Master Screen IOS VIASYS was used, the examinee breathed quietly through the mouthpiece with his/her nose closed for a period of 1 minute. In this way we measured the impedance Z at 5 Hz, the resistance to 5,10,20 Hz respectively, the reactance in 5,10,20 Hz respectively, the central and peripheral airway resistance and resonant frequency.

Rhinomanometry was done by the Master Screen IOS VIASYS system, the examinee breathed calmly through the examined nostril, while the other was closed, 5 breaths per attempt were performed. After 3 attempts for each nostril, we assessed the average inspiratory resistance for each nostril separately.

The plethysmography took place on the Master Screen Body of VIASYS, the door of the Body was closed as well as all the doors of the room and without the presence of motion in the test room. The subject performed calm breaths with a closed nose, through the mouthpiece and then took a deep breath, followed by deep exhalation. At the end of the effort we had values for the total lung capacity (TLC), residual volume (RV), airway resistance (R), vital capacity (VC), the functional residual capacity (FRC), Exhaled residual volume (ERV) and the ratio RV / TLC. This was repeated 3 times and one was selected to be the most representative.

The P.100 was performed through the Master Screen Body of VIASYS with the door of the Body Box opened. The volunteer was performing calm breaths with a closed nose, through the mouthpiece, during which a shutter blocked the flow. The obtained value of the pressure was the one that developed in the first second of inhalation with the shutter down is noted. This repeated 3 times and one selected to be the most representative.

Spirometry and the flow-volume curve were assessed with a Master Screen Body of VIASYS with the door of the Body Box opened as follows: The subject performed tidal breathing with a closed nose, through the mouthpiece, and then took a sharp deep breath, which was followed by sharp deep exhalation, and the test ended with deep inhalation. At the end of the effort we had values for forced vital capacity (FVC), the violent expiratory the first volume 1 (FEV1), the ratio FVC/FEV1%, peak expiratory flow (PEF) and mesoexpiratory flow in peripheral airways than 25% to 75% of vital capacity. This was repeated 3 times and one was selected to be the most representative.

The assessment of the type of breathing during exposure to secondhand smoke was performed through the VIASYS Respitrace. The protocol was as follows: The volunteer breathed calmly over 20 times with the mouth closed and once with a closed nose, while wearing two rubber bands, one on the chest and one to the abdomen, which incorporates electrodes. The waveform of the breath in the thorax, abdomen and the average of these was recorded in real time. Also, for every breath we had values for the inspiratory time, expiratory time, total time, the participation rate of the chest, the participation rate of the ventricle, the peak inspiratory flow (Pif), the mean inspiratory flow (Mif), and the flow-volume curve and the analysis chart of each breath in the thoracic and abdominal component.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

21

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Attiki
      • Athens, Attiki, Griekenland
        • Hellenic Anticancer Society

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • healthy volunteer adults non-smokers

Exclusion Criteria:

  • < 18 years old
  • Recent or chronic disease of the upper or lower respiratory system.
  • Current pregnancy
  • Breastfeeding women

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: nasal breathing

At the time that the exposure took place with nasal breathing, the study was as follows:

Before the exposure: rhinomanometry, IOS , FeNO , spirometry, plethysmography, P.100.

Exposure to second hand smoking:Each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence.

After the exposure: rhinomanometry, IOS , FeNO , spirometry,plethysmography , P.100.

The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room. A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation). The exposure was sometimes with closed mouth and others with closed nose in random sequence.
Experimenteel: oral breathing

At the time that the exposure took place with oral breathing, the study was as follows:

Before the exposure: IOS, exhaled nitric oxide (FeNO), spirometry, plethysmography and P.100.

Exposure to second hand smoking: each volunteer was exposed to secondhand smoking twice, for 20 minutes, once with nasal breathing and once with oral breathing, with 3 days interval and in random sequence.

After the exposure: IOS, FeNO, spirometry,plethysmography and P.100.

The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room. A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation). The exposure was sometimes with closed mouth and others with closed nose in random sequence.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
exhaled nitric oxide (FeNO) for the respiratory tract
Tijdsspanne: before exposure (Baseline) and after exposure with a 30 minutes interval
To compare the changes between the two types of breathing
before exposure (Baseline) and after exposure with a 30 minutes interval
plethysmography
Tijdsspanne: before exposure (Baseline) and after exposure with a 30 minutes interval
plethysmography take place both at oral and nasal breathing twice before and after intervention.
before exposure (Baseline) and after exposure with a 30 minutes interval

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Eye or nose irritation
Tijdsspanne: during the exposure to second hand smoke
During the exposure to second hand smoke that lasted 20 minutes the examinee had his /her mouth closed and filled in an evaluation Questionnaire about eye or nose irritation.
during the exposure to second hand smoke

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Panagiotis K Behrakis, Professor, National and Kapodistrian University of Athens
  • Hoofdonderzoeker: Palagia M Karas, MD, National and Kapodistrian University of Athens

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2011

Primaire voltooiing (Werkelijk)

1 februari 2013

Studie voltooiing (Werkelijk)

1 juli 2013

Studieregistratiedata

Eerst ingediend

28 oktober 2013

Eerst ingediend dat voldeed aan de QC-criteria

13 november 2013

Eerst geplaatst (Schatting)

20 november 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

20 november 2013

Laatste update ingediend die voldeed aan QC-criteria

13 november 2013

Laatst geverifieerd

1 november 2013

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 6322/6.3.13

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op exposure to second hand smoking

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