Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System

Completed

• Conditions: Carboxyhemoglobin; Vital Signs; Fractional Exhaled NO; Exhaled Breath Condensate

• Registration Number: NCT01157832
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
carboxy- hemoglobin	before and immediatly after 30 min of smoking	blood test

Secondary Outcome Measures

Name	Time	Method
Exhaled breath Condensate	before and immediatly after 30 min of smoking	R-tube tests
Fractional Exhaled NO	before and immediatly after 30 min of smoking	Exhaled NO test
Eosinophils count	before and immediatly after 30 min of smoking	blood test
heart rate	before and immediatly after 30 min of smoking	heart beats count
Respiratory rate	before and immediatly after 30 min of smoking	Respiratory rate
Blood pressure	before and immediatly after 30 min of smoking	Non Invasive Blood pressure mesaurement
Spirometry	before and immediatly after 30 min of smoking	Pulmonary function test
Visual Analog Score 1-10 (1=bad 10=good)	before and immediatly after 30 min of smoking	Questionnaire

Trial Locations

Locations (2)

RAMBAM Health Care Campus; 🇮🇱 Haifa, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel