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临床试验/NCT02963467
NCT02963467Unknown不适用

Acute Effect of Smoking Cigarettes on Ventilation-Perfusion Ratio: A Pilot Study in Healthy Volunteers

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
ventilation-perfusion ratio by MMIMS-MIGET

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • normal body mass index (BMI)

排除标准

  • 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)

研究组 & 干预措施

Healthy Volunteers - non-smokers

Other

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.

干预措施: "dummy cigarette" (Procedure)

Healthy Volunteers - occasional smokers

Other

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.

干预措施: cigarette (Procedure)

Healthy Volunteers - heavy-smokers

Other

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.

干预措施: cigarette (Procedure)

结局指标

主要结局

ventilation-perfusion ratio by MMIMS-MIGET

时间窗: within a time-frame of 6 hours

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)

次要结局

  • serum nicotine by blood sampling(within a time-frame of 6 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ass.-Prof. Dr. Stefan Boehme

Assistent Professor

Medical University of Vienna

研究点 (2)

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