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

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ClinicalTrials.gov Identifier: NCT01237548
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : June 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief 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.


Condition or disease Intervention/treatment
Healthy Other: Smoking Narghile for 30 min

Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. carboxy- hemoglobin [ Time Frame: before and immediatly after 30 min of smoking ]
    Blood Test

  2. heart rate [ Time Frame: before and immediatly after 30 min of smoking ]
    Heart Beats count

  3. Visual Analog Score 1-10 (1=bad 10=good) [ Time Frame: before and immediatly after 30 min of smoking ]
    Questionnaire

  4. Respiratory Rate [ Time Frame: before and immediatly after 30 min of smoking ]
  5. Spirometry [ Time Frame: before and immediatly after 30 min of smoking ]
    Koko spirometry system

  6. Eosinophils Count [ Time Frame: before and immediatly after 30 min of smoking ]
    Blood Test

  7. Blood Pressure [ Time Frame: before and immediatly after 30 min of smoking ]
    Regular Blood Pressure assesment

  8. Exhaled Breath Condensate [ Time Frame: before and immediatly after 30 min of smoking ]
    R-tubes test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal People who have smoked Water-pipe, at least once before.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237548


Locations
Israel
Rambam Medical Center
Haifa, Israel, 32000
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Lea Bentur, Prof Rambam Health Care Campus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01237548     History of Changes
Other Study ID Numbers: Narghile Endotheil RMC 284
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Keywords provided by Rambam Health Care Campus:
water pipe smoking
acute effect
Endothelial
healthy adults who smoke narghile