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

June 10, 2013 updated by: Rambam Health Care Campus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 32000
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal People who have smoked Water-pipe, at least once before.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRE - Endothelial Function as assessed by EndoPAT2000
Time Frame: baseline (before smoking narghile)
as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
baseline (before smoking narghile)
POST - Endothelial Function as assessed by EndoPAT2000
Time Frame: after 30 minutes of smoking narghile
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
Visual Analog Score 1-10 (1=bad 10=good)
Time Frame: before and immediatly after 30 min of smoking
Questionnaire
before and immediatly after 30 min of smoking
carboxy- hemoglobin
Time Frame: before and immediatly after 30 min of smoking
Blood Test
before and immediatly after 30 min of smoking
heart rate
Time Frame: before and immediatly after 30 min of smoking
Heart Beats count
before and immediatly after 30 min of smoking
Respiratory Rate
Time Frame: before and immediatly after 30 min of smoking
before and immediatly after 30 min of smoking
Spirometry
Time Frame: before and immediatly after 30 min of smoking
Koko spirometry system
before and immediatly after 30 min of smoking
Eosinophils Count
Time Frame: before and immediatly after 30 min of smoking
Blood Test
before and immediatly after 30 min of smoking
Blood Pressure
Time Frame: before and immediatly after 30 min of smoking
Regular Blood Pressure assesment
before and immediatly after 30 min of smoking
Exhaled Breath Condensate
Time Frame: before and immediatly after 30 min of smoking
R-tubes test
before and immediatly after 30 min of smoking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Lea Bentur, Prof, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Narghile Endotheil RMC 284

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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