Bystanders' Exposure to Electronic Cigarette Aerosol in Confined Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in airborne nicotine concentration (mg/m3)
研究概览
简要总结
Objective of this study is to investigate the bystanders' exposure to e-cigarette emissions in controlled conditions in confined settings.
Design: a cross-sectional experimental study developed in two settings: a car and a room. The experimental study will be replicated 5 times in each setting.
Three volunteers will be enrolled: 2 non-users of e-cigarettes (and non-smokers of any tobacco or nicotine product) and 1 exclusive e-cigarette user (not using any other tobacco or nicotine product) to create aerosol.
In brief, during the experimental session the e-cigarette user will be asked to use electronic cigarette during 30 minutes and two non-smokers will sit next to the user.
Individual exposure will be measured through saliva sample collection and irritation symptoms questionnaire to be collected 4 times: before exposure, just after 30 minutes of exposure, 30 minutes after the end of exposure and 3 hours after the end of exposure. Moreover, environmental exposure will be measured prior (5 min), during (30 min) and after (5 min) the exposure; particulate matter and airborne nicotine concentrations will be measure for this purpose.
详细描述
Objective: to investigate the bystanders' exposure to e-cigarette emissions in controlled conditions in confined settings.
Methods
Study design: this is a cross-sectional experimental study developed in two settings: a car and a room. The experimental study will be replicated 5 times in each setting.
It is important to notice that this study is an ad hoc experiment with volunteers and therefore it is not a clinical trial.
Study population: 3 volunteers will be enrolled: 2 non-users of e-cigarettes (and non-smokers of any tobacco or nicotine product) and 1 exclusive e-cigarette user (not using any other tobacco or nicotine product). Participants will be recruited through personal contacts of the research team and, if necessary, through social networks. All volunteers will receive a compensation for their participation in all replicates in both settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For e-cigarette non-users
- •Adult (18 years old and above)
- •Non-e-cigarette user (never user or more than 6 months former e-cigarette user)
- •Non-smoker or user of any kind of tobacco/nicotine product (never or ex-smoker for >6 months)
- •Not being regularly exposed to cigarettes or e-cigarettes at home or other settings
- •For the e-cigarette user
- •Adult (18 years old and above)
- •Daily user of e-cigarettes (at least 2 months)
- •Non-user of any other tobacco/nicotine products for at least 2 months
排除标准
- •For all participants:
- •Pregnancy or breastfeeding
- •Ongoing or recent illness (<4 weeks prior to the study)
- •Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension or other)
- •Any type of medication (<2 weeks prior to the study)
结局指标
主要结局
Change in airborne nicotine concentration (mg/m3)
时间窗: Pre-exposure (5 minutes*5 replications in two settings: car and room); concentration during the exposure (30 minutes*5 replications in two settings: car and room); Post-exposure (5 minutes*5 replications in two settings: car and room)
Airborne nicotine concentration: median measurements for pre-exposure, during and post-exposure; change between pre-exposure, exposure and post-exposure periods
次要结局
- Change of in the individual exposure to tobacco related biomarkers (ng/ml)(Median concentrations at four points: before exposure, 1 minute after the exposure, 30 minutes after the end of exposure, 3 hours after the end of exposure)
- Change in particulate matter concentration (PM2.5; mg/m3)(Pre-exposure (5 minutes*5 replications in two settings: car and room); concentration during the exposure (30 minutes*5 replications in two settings: car and room); Post-exposure (5 minutes*5 replications in two settings: car and room))
- Changes in the irritation symptoms reported before and after exposure(Irritation symptoms at four points: before exposure, 1 minute after the exposure, 30 minutes after the end of exposure, 3 hours after the end of exposure)