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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01237548
First received: November 3, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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 Intervention
Healthy
Other: Smoking Narghile for 30 min

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • PRE - Endothelial Function as assessed by EndoPAT2000 [ Time Frame: baseline (before smoking narghile) ] [ Designated as safety issue: No ]
    as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function

  • POST - Endothelial Function as assessed by EndoPAT2000 [ Time Frame: after 30 minutes of smoking narghile ] [ Designated as safety issue: No ]
    as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function


Secondary Outcome Measures:
  • carboxy- hemoglobin [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: Yes ]
    Blood Test

  • heart rate [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Heart Beats count

  • Visual Analog Score 1-10 (1=bad 10=good) [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Questionnaire

  • Respiratory Rate [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
  • Spirometry [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Koko spirometry system

  • Eosinophils Count [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Blood Test

  • Blood Pressure [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Regular Blood Pressure assesment

  • Exhaled Breath Condensate [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    R-tubes test


Enrollment: 62
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01237548     History of Changes
Other Study ID Numbers: Narghile Endotheil RMC 284
Study First Received: November 3, 2010
Last Updated: June 10, 2013
Health Authority: ISRAEL: Rambam Health Care Campus

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

Additional relevant MeSH terms:
Smoking
Habits
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014