Carbon Monoxide and Oxidative Stress in Waterpipe Smokers

Study Overview
=================
Brief Summary
-----------------
Waterpipe is a tool for smoking tobacco, which is thought to be less harmful than cigarette. Unfortunately, there aren't adequate studies about its harms to health that are threatening the young generation all over the world today. The objective of this study was to show the carbon monoxide (CO) levels in waterpipe smokers' breaths, whether can be used or not to reflect the changes of oxidative stress for this reason to predict harmful effects on the pulmonary functions.

Detailed Description
-----------------
Waterpipe or hookah uses a different kind of tobacco, which is available in most Balkan countries, Middle East and South Asia. Popularity of smoking waterpipe among European, Canadian, and American young people has shown a dramatic rise over the past decade. The growing popularity of waterpipe use among U.S. teens and adults is evidenced by media reports and the recent rapid proliferation of waterpipe establishments (bars, cafes, or restaurants) in large cities and near college campuses. Typical waterpipes have the following components; a bowl where the tobacco is placed and heated, usually with burning embers or charcoal, a vase or smoke chamber which is partially filled with water, a pipe or stem connecting the bowl to the vase by a tube that carries the smoke down into the water, and a hose with a mouthpiece through which the smoke is drawn from the vase. As the smoker inhales, the tobacco smoke is sucked down from the bowl and then bubbles up through the water into the air of the smoke chamber and then through the hose to the smoker. At the end of a smoking session, the dirty water is thrown away and the waterpipe vase is refilled for the next user. Although each smoking session generally lasts about 45 to 60 minutes, it can also continue for several hours. There is a misconception about smoking waterpipe that it is less harmful than cigarettes, and that's why smoking waterpipe is dramatically increasing especially among young people. While the adverse effects of smoking cigarette are widely described, there are just a few investigations about waterpipe and its effects. This study was designed to investigate the effects of smoking waterpipe on pulmonary functions and oxidative stress parameters.

Official Title
-----------------
Breath Carbon Monoxide Measurement Predicts Oxidative Stress Which Cause of Deteriorations of Lung Functions in Waterpipe Smokers

Conditions
-----------------
Waterpipe Smoking, Oxidative Stress

Intervention / Treatment
-----------------
* Procedure: Breath carbon monoxide
* Procedure: Pulmonary function tests.
* Procedure: Oxidative stress and antioxidant status.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who haven't determined major health problems, between ages 18-40. Exclusion Criteria: Participants who under age 18 and above 40, pregnant women, individuals who have major health problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Waterpipe smokers group<br>Three waterpipe cafes located in Ankara were visited. 50 waterpipe smokers aged 18-40 years, enrolled in the study and created the working group. At the same time, there were also cigarette smokers among these people. Breath carbon monoxide, pulmonary function tests were performed both before and after smoking waterpipe and parameters of oxidative stress and antioxidant status were measured in blood samples after smoking waterpipe. | Procedure: Breath carbon monoxide<br>* Breath carbon monoxide measurement.<br>Procedure: Pulmonary function tests.<br>* Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.<br>* Other names: Spirometry;Procedure: Oxidative stress and antioxidant status.<br>* Measurement of parameters of oxidative stress and antioxidant status in blood samples.<br>|
| Active Comparator: Control group<br>The control group consisted of 50 people of the same age and sex, who had never smoked neither cigarette nor waterpipe. Breath carbon monoxide, pulmonary function tests were performed and parameters of oxidative stress were measured in blood samples. | Procedure: Breath carbon monoxide<br>* Breath carbon monoxide measurement.<br>Procedure: Pulmonary function tests.<br>* Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.<br>* Other names: Spirometry;Procedure: Oxidative stress and antioxidant status.<br>* Measurement of parameters of oxidative stress and antioxidant status in blood samples.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath Carbon Monoxide Level | Levels of CO in breath will be measured in either waterpipe smokers or control group. | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A spirometric Test; FEV1 (Forced Expiratory Volume in One Second) Measurement. | FEV1 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| A spirometric Test; FVC (Forced Vital Capacity) Measurement. | FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| A spirometric Test; FEV1/FVC (Forced Expiratory Volume in One Second/Forced Vital Capacity) Measurement. | FEV1/FVC Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| A spirometric Test; PEF (Peak Expiratory Flow) Measurement. | PEF Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| A spirometric Test; FEF25-75 (Forced Expiratory Flow in 25-75%) Measurement. | FEF25-75 Will Be Measured To Evaluation of Deterioration Levels of Pulmonary Functions in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma TAS (Total Anti-Oxydant Status) Measurement. | To Assessment of Anti-Oxidant Status: TAS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma TOS (Total Oxydative Stress) Measurement. | To Assessment of Oxidative Stress: TOS Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma OSI Measurement. | To Assessment of Antioxidant Status: TAS (Total Anti-oxydative Status) Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma PON (Paraoxonase) Measurement. | To Assessment of Antioxidant Status: PON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma sPON (Stimulated Paraoxonase) Measurement. | To Assessment of Antioxidant Status: sPON Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 
| Plasma ARES (Arylesterase) Measurement. | To Assessment of Arylesterase Activity: ARES Levels in Plasma Will Be Measured in Either Waterpipe Smokers or Control Group. | Up to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon monoxide, oxidative stress, waterpipe smoking, cigarette smoking, pulmonary function test