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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014