The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System

Study Overview
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Brief Summary
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Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath condensate (EBC) and pulmonary function tests in healthy volunteers. Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy volunteers. Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile smoking. The changes in inflammatory parameters pre and post smoking will be evaluated blindly. Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile . Intervention: Each subject will undergo evaluation including a respiratory questionnaire, endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes narghile smoking.

Conditions
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Healthy

Intervention / Treatment
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* Other: Smoking Narghile for 30 min


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Y.O. Have smoked Water-pipe at least once before. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Normal People who have smoked Water-pipe, at least once before. | Other: Smoking Narghile for 30 min<br>* No Other intervention will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRE - Endothelial Function as assessed by EndoPAT2000 | as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function | baseline (before smoking narghile) | 
| POST - Endothelial Function as assessed by EndoPAT2000 | as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function | after 30 minutes of smoking narghile | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carboxy- hemoglobin | Blood Test | before and immediatly after 30 min of smoking | 
| heart rate | Heart Beats count | before and immediatly after 30 min of smoking | 
| Visual Analog Score 1-10 (1=bad 10=good) | Questionnaire | before and immediatly after 30 min of smoking | 
| Respiratory Rate |  | before and immediatly after 30 min of smoking | 
| Spirometry | Koko spirometry system | before and immediatly after 30 min of smoking | 
| Eosinophils Count | Blood Test | before and immediatly after 30 min of smoking | 
| Blood Pressure | Regular Blood Pressure assesment | before and immediatly after 30 min of smoking | 
| Exhaled Breath Condensate | R-tubes test | before and immediatly after 30 min of smoking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water pipe smoking, acute effect, Endothelial, healthy adults who smoke narghile