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临床试验/NCT01988467
NCT01988467已完成1 期

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

Hellenic Anticancer Society1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
21
试验地点
1
主要终点
exhaled nitric oxide (FeNO) for the respiratory tract

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteer adults non-smokers

排除标准

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

结局指标

主要结局

exhaled nitric oxide (FeNO) for the respiratory tract

时间窗: before exposure (Baseline) and after exposure with a 30 minutes interval

To compare the changes between the two types of breathing

plethysmography

时间窗: 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.

次要结局

  • Eye or nose irritation(during the exposure to second hand smoke)

研究者

发起方
Hellenic Anticancer Society
申办方类型
Other
责任方
Sponsor

研究点 (1)

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