search
Back to results

Effect of Smoking on Ventilation-Perfusion Ratio

Primary Purpose

Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
cigarette
"dummy cigarette"
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Disease focused on measuring multiple inert gas elimination technique, smoking, pulmonary disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy Volunteers - non-smokers

Healthy Volunteers - occasional smokers

Healthy Volunteers - heavy-smokers

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

ventilation-perfusion ratio by MMIMS-MIGET
V/Q-ratio as well as shunt, low V/Q, normal V/Q and high V/Q i.e. deadspace will be assessed by micropore-membrane inlet mass-spectrometry multiple inert gas elimination technique (MMIMS-MIGET)

Secondary Outcome Measures

serum nicotine by blood sampling
the serum nicotine level will be assessed by clinical chemistry

Full Information

First Posted
November 4, 2016
Last Updated
March 12, 2019
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02963467
Brief Title
Effect of Smoking on Ventilation-Perfusion Ratio
Official Title
Acute Effect of Smoking Cigarettes on Ventilation-Perfusion Ratio: A Pilot Study in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
multiple inert gas elimination technique, smoking, pulmonary disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers - non-smokers
Arm Type
Other
Arm Description
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.
Arm Title
Healthy Volunteers - occasional smokers
Arm Type
Other
Arm Description
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.
Arm Title
Healthy Volunteers - heavy-smokers
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cigarette
Other Intervention Name(s)
smoking
Intervention Description
smoking 4 conventional cigarettes
Intervention Type
Procedure
Intervention Name(s)
"dummy cigarette"
Other Intervention Name(s)
smoking
Intervention Description
smoking a "dummy cigarette"
Primary Outcome Measure Information:
Title
ventilation-perfusion ratio by MMIMS-MIGET
Description
V/Q-ratio as well as shunt, low V/Q, normal V/Q and high V/Q i.e. deadspace will be assessed by micropore-membrane inlet mass-spectrometry multiple inert gas elimination technique (MMIMS-MIGET)
Time Frame
within a time-frame of 6 hours
Secondary Outcome Measure Information:
Title
serum nicotine by blood sampling
Description
the serum nicotine level will be assessed by clinical chemistry
Time Frame
within a time-frame of 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Boehme, Ass.-Prof. Dr.
Phone
00436766767144
Email
stefan.boehme@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Jilma, Ao.Univ.-Prof.Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Smoking on Ventilation-Perfusion Ratio

We'll reach out to this number within 24 hrs