Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- temperature of exhaled air
研究概览
简要总结
The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Subjects were divided into 4 groups (n=30 each) based on their self-declared smoking status: control (C), tobacco cigarette smokers (T-Smokers), exclusive e-cigarette users (E-Smokers) and dual users (T/E-Smokers).
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoking status (cigarette or e-cigarette smoking)
排除标准
- •occurrence of any chronic diseases,
- •history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
- •presence of any allergic diseases,
- •medication intake within the last 2 weeks,
- •acute illnesses or infections in the last 2 weeks,
- •influenza vaccination in the last 2 weeks,
- •or current pregnancy or lactation.
研究组 & 干预措施
T-smokers
T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits.
干预措施: Cigarette smoking (Behavioral)
E-smokers
E-smokers were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
干预措施: E-cigarette use (Behavioral)
T/E-smokers
T/E-smokers (dual users) were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
干预措施: E-cigarette use (Behavioral)
Control subjects
The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).
干预措施: Simulation of the use of e-cigarette (Behavioral)
结局指标
主要结局
temperature of exhaled air
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
The measurement was made using the standard procedure in the sitting position using an X-Halo Breath Thermometer \[20\]. Respondents were instructed to breathe according to the procedure recommended by the device manufacturer. The temperature of exhaled air was expressed in Celsius degrees (°C).
exhaled carbon monoxide (CO)
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
During the measurement, requirements regarding the length and intensity of the exhalation were taken into account. The measurements were made using the PiCo Smokylyzer device. The measured CO levels were expressed in ppm (parts per million).
spirometric testing
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
Airflow and lung volume were measured in the sitting position with a noseclip according to the ATS/ERS guidelines. The measurements were made using the EasyOne 2001 spirometer and included FEV1, FVC, FEV1% FVC, PEF and MEF75,50,25. Expiratory maneuvers were repeated until a minimum of three technically correct, repeatable measurements were obtained.
heart rate
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
Heart rate was measured in the sitting position, the result of measurement was expressed in beats per minute.
Concentration of nitric oxide (FeNO)
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
FeNO measurements were made using the standard procedure in the sitting position with a clip attached to the nose using a NIOX MINO device for measuring fractional exhaled nitric oxide (FeNO). Subjects were instructed to breathe as deeply as possible through the mouthpiece to achieve maximum lung filling and then to exhale 50ml/sec for 10s. The measured FeNO values were expressed in ppb (parts per billion).
O2 saturation
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
The O2 measurement was made in the sitting position using the PULSOX 2 electronic pulse meter. The result was recorded 15 seconds after the start of the measurement.
blood pressure
时间窗: pre - post (1 minute after exposure) - post (30 minute after exposure)
Blood pressure was measured in the sitting position, the result of measurement was expressed in mmHg.
次要结局
未报告次要终点
研究者
Mateusz Jankowski
Principal Investigator
Medical University of Silesia