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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01237548
First received: November 3, 2010
Last updated: November 27, 2010
Last verified: August 2010

November 3, 2010
November 27, 2010
January 2011
 
  • 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
Same as current
Complete list of historical versions of study NCT01237548 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System
 

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.

 
Observational
Observational Model: Case Control
Time Perspective: Prospective
 
Non-Probability Sample

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
 
 

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
Both
18 Years and older
Yes
Contact: Lea Bentur, Prof. 972 854 3263 L_bentur@rambam.health.gov.il
Israel
 
NCT01237548
Narghile Endotheil RMC 284
Yes
Prof. Lea Bentur, Rambam Health Care Campus
Rambam Health Care Campus
 
Principal Investigator: Lea Bentur, Prof Rambam Health Care Campus
Rambam Health Care Campus
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP