Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- carboxy- hemoglobin
研究概览
简要总结
Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) pulmonary function tests in healthy volunteers
Objectives: To evaluate the acute effect of one cession of water pipe smoking on airway inflammation as assessed by exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) in healthy volunteers.
Design: Prospective study evaluating these parameters before and after 30 minutes of water pipe smoking . The changes in inflammatory parameters pre and post smoking will be evaluated blindly.
Sample size: 100 participants Participant selection: Adults subjects who regularly smoke water pipe . Intervention: Each subject will undergo evaluation including a respiratory questionnaire , pulmonary function tests , exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes water pipe smoking
Primary outcome parameter: Change in carboxy- hemoglobin Secondary outcome parameter:Change in peripheral eosinophils count, pulmonary function tests, change in FeNO, and in inflammatory parameters in EBC before and after water pipe smoking
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 Y.O.
- •Have smoked Water-pipe at least once before.
排除标准
- •Breast feeding Women.
- •S/P Bacterial Or Viral infection, Last 2 weeks
- •P.O. Steroids
- •Water-pipe smoking, last 24 hours
- •Cigarette smoking, last 6 hours
- •Intensive exposure to smoke (fire), last 24 hours
- •S/P Intensive Care Hospitalization, last 3 months
结局指标
主要结局
carboxy- hemoglobin
时间窗: before and immediatly after 30 min of smoking
blood test
次要结局
- Eosinophils count(before and immediatly after 30 min of smoking)
- heart rate(before and immediatly after 30 min of smoking)
- Respiratory rate(before and immediatly after 30 min of smoking)
- Blood pressure(before and immediatly after 30 min of smoking)
- Spirometry(before and immediatly after 30 min of smoking)
- Visual Analog Score 1-10 (1=bad 10=good)(before and immediatly after 30 min of smoking)
- Exhaled breath Condensate(before and immediatly after 30 min of smoking)
- Fractional Exhaled NO(before and immediatly after 30 min of smoking)