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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237548
• Other study ID #: Narghile Endotheil RMC 284
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: June 10, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: ISRAEL: Rambam Health Care Campus
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Smoking Narghile for 30 min
No Other intervention will be used

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRE - Endothelial Function as assessed by EndoPAT2000	as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function	baseline (before smoking narghile)	No
Primary	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	No
Secondary	carboxy- hemoglobin	Blood Test	before and immediatly after 30 min of smoking	Yes
Secondary	heart rate	Heart Beats count	before and immediatly after 30 min of smoking	No
Secondary	Visual Analog Score 1-10 (1=bad 10=good)	Questionnaire	before and immediatly after 30 min of smoking	No
Secondary	Respiratory Rate		before and immediatly after 30 min of smoking	No
Secondary	Spirometry	Koko spirometry system	before and immediatly after 30 min of smoking	No
Secondary	Eosinophils Count	Blood Test	before and immediatly after 30 min of smoking	No
Secondary	Blood Pressure	Regular Blood Pressure assesment	before and immediatly after 30 min of smoking	No
Secondary	Exhaled Breath Condensate	R-tubes test	before and immediatly after 30 min of smoking	No