Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Peak Expiratory Flow
研究概览
简要总结
IQOS ("I-Quit-Ordinary-Smoking,") is a type of "heat-not-burn" (HNB) tobacco product. There is evidence of a growing number of young people who try IQOS as a 'safe' alternative of cigarette. The effect of the acute exposure to IQOS smoke on pulmonary function of healthy non smokers has not been studied extensively.
Objectives: Evaluation of the acute effects of IQOS on pulmonary function,exhaled CO, O2 Saturation, arterial pressure and heart rate.
Methods: Healthy non smokers, underwent exhaled CO measurement, spirometry including flows, volumes and diffusion capacity, and measurement of their respiratory resistances at 5, 10 and 20 Hz (R5Hz, R10Hz and R20Hz) with the use of an impulse oscillometry system (IOS) before and after the use of an IQOS. Additionally heart rate and arterial blood pressure were also measured.
详细描述
All participants underwent pulmonary function tests (PFT) (MasterScreen PFT, Jaeger, Wurzburg, Germany) and total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system).From the basic pulmonary measurements (flows and dynamic lung volumes), Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Tiffenau index (FEV1/FVC, FEV1%), Peak Expiratory Flow (PEF), Maximal Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity, Functional Residual Capacity (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Diffusion Capacity (DLCO) were measured. Each manoeuvre was repeated for at least three technically acceptable forced expiratory flow curves in order to attain the best results. Respiratory impedance at 5 Hz (Z5Hz) and respiratory resistance at 5, 10, and 20 Hz (R5Hz, R10Hz, and R20Hz, respectively), reactance at 5, 10, and 20 Hz and resonant frequency were assessed with IOS. Heart rate, saturation of O2 (oxymetry) and arterial blood pressure were also measured. Exhaled CO measurement (piCO Smokerlyzer,Bedfont Scientific Ltd, Kent, U.K.) was performed After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs, IOS, exhaled CO heart rate, saturation of O2 (oximetry) and arterial blood pressure measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male non smokers,
- •Age 18-55 years
- •receiving no medications
- •no co morbidity -
排除标准
- •aged <18 years
- •smokers or ex-smokers
- •receiving any medications
- •any co morbidity -
结局指标
主要结局
Peak Expiratory Flow
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Peak Expiratory Flow (PEF), (liters/second )
Forced Expiratory Volume in 1 second
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Forced Expiratory Volume in 1 second (FEV1), (liters)
Tiffenau index
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Tiffenau index (FEV1/FVC, FEV1%)
Total Lung Capacity (TLC)
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Total Lung Capacity (TLC), (liters)
Forced Vital Capacity
时间窗: immediatly (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Forced Vital Capacity (FVC), (liters)
Diffusion Capacity (DLCO)
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Diffusion Capacity (DLCO) ((mmol/min/kPa)
Total respiratory resistances
时间窗: immediately (max 5 min)
Total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system) prior to smoking heated tobacco IQOS and 5 minutes after smoking IQOS were performed. The changes in: respiratory resistance at 5 (R5Hz),10 Hz (R10Hz),20 Hz (R20Hz) (kPa/L/sec) were assessed
Functional Residual Capacity (FRC)
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in:Functional Residual Capacity (FRC), (liters)
Residual Volume (RV)
时间窗: immediately (max 5 min)
Pulmonary function tests (PFT) prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in: Residual Volume (RV), (liters)
Oxygen Saturation
时间窗: immediately (max 5 min)
Oxygen Saturation prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Oxygen Saturation were measured by oximetry
Heart rate
时间窗: immediately (max 5 min)
Heart rate prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Heart rate were measured by oximetry
Respiratory impedance
时间窗: immediately (max 5 min)
Total respiratory resistances measurement with an impulse oscillometry system (IOS)( (Viasys Jaeger MasterScreen IOS system) prior to smoking heated tobacco IQOS and 5 minutes after smoking IQOS were performed. The changes in: Respiratory impedance at 5 Hz (Z5Hz) (kPa/L/sec) were assessed
Arterial Blood Pressure
时间窗: immediately (max 5 min)
Arterial Blood Pressure prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Arterial Blood Pressure were measured (mmHg)
Exhaled CO
时间窗: immediately (max 5 min)
Exhaled CO prior to smoking heated tobacco IQOS and 5 minutes after IQOS. The changes in Exhaled CO were measured by (piCO Smokerlyzer) (ppm)
次要结局
未报告次要终点
研究者
Athanasia Pataka
Assistant Professor of Respiratory Medicine
Aristotle University Of Thessaloniki