Effect of Smoking on Ventilation-Perfusion Ratio

NCT ID: NCT02963467

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-09-30

Brief Summary

Smoking is one of the world's leading health hazards. Besides being a major risk factor in the etiology of COPD and lung cancer, cigarette smoke is also a causative agent lung diseases characterized by bronchiolar and interstitial inflammation. However, the associated lung pathology of smoking is not only a risk in the development of lung diseases, but also widely recognized as a major risk factor associated with perioperative respiratory and cardiovascular complications. Apart from the long term effects of cigarette smoke, acute effects of the inhalation of cigarettes smoke may influence the course of lung pathology. The inhalation of smoke causes inflammation in the lung by inducing chemotaxis and activation of neutrophils and macrophages and induces oxidative stress. As the acute inflammatory response to smoke inhalation seems to be the underlying mechanism for chronic diseases of smokers, exploring the field of the acute pulmonary changes after exposure to cigarette smoke is highly relevant. One reason for acute hypoxia and injury during smoking might be a severe mismatch of ventilation and perfusion of the lung. Using the multiple inert gas elimination technique (MIGET), a distribution of ventilation-perfusion ratios in the lung can be calculated by analyzing data on the retention and excretion of six infused inert gases. A saline solution containing the gases is infused intravenously. When passing through the lung the gases are either eliminated from the blood or retained depending on their partition coefficient and local V/Q ratio. The concentrations of the gases are measured in the mixed venous blood or the mixed expired gas and the arterial blood allowing for the calculation of retention and excretion and the derivation of V/Q distribution. MIGET is the experimental gold standard to determine the Ventilation-Perfusion ratio of the lung. The aim of this study is to show the acute effect of smoking on ventilation/perfusion ratio distribution in the lung in otherwise healthy smokers.

Conditions

Lung Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers - non-smokers

control group: After baseline measurements V/Q will be measured by MIGET. After a 2 hour wash out period, the Volunteers will smoke a dummy cigarette. Then V/Q will be measured again after 15 minutes.

Group Type: OTHER

"dummy cigarette"

Intervention Type: PROCEDURE

smoking a "dummy cigarette"

Healthy Volunteers - occasional smokers

intervention: After baseline measurements V/Q will be measured by MIGET. After a 2 hour wash out period, the Volunteers will smoke 4 conventional cigarettes. Thereafter, V/Q will be measured again after 15, 30, 45, 60 and 120 minutes.

Group Type: OTHER

cigarette

Intervention Type: PROCEDURE

smoking 4 conventional cigarettes

Healthy Volunteers - heavy-smokers

intervention: After baseline measurements V/Q will be measured by MIGET. After a 2 hour wash out period, the Volunteers will smoke 4 conventional cigarettes. Thereafter, V/Q will be measured again after 15, 30, 45, 60 and 120 minutes.

Group Type: OTHER

cigarette

Intervention Type: PROCEDURE

smoking 4 conventional cigarettes

Interventions

cigarette

smoking 4 conventional cigarettes

Intervention Type: PROCEDURE

"dummy cigarette"

smoking a "dummy cigarette"

Intervention Type: PROCEDURE

Other Intervention Names

smoking; smoking

Eligibility Criteria

Inclusion Criteria

• normal body mass index (BMI)

Exclusion Criteria

• Medical history of pulmonary or cardiovascular disease
• Family history of malignant hyperthermia, neuro-muscular disorders
• Known hypersensitivity to any of the inert gases or substances administered
• History of post operative nausea and vomiting
• Pregnancy (pregnancy test will be performed on study day)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Ass.-Prof. Dr. Stefan Boehme

Assistent Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Stefan Boehme, Ass.-Prof. Dr.

Role: CONTACT

stefan.boehme@meduniwien.ac.at

00436766767144

Facility Contacts

Bernd Jilma, Ao.Univ.-Prof.Dr.

Role: primary

Other Identifiers

1133/2013

Identifier Type: -

Identifier Source: org_study_id