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

NCT01237548 | Completed DMC

• 1 other identifier: Narghile Endotheil RMC 284
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

water pipe smoking; acute effect; Endothelial; healthy adults who smoke narghile

Outcome Measures

Primary Outcomes (2)

• PRE - Endothelial Function as assessed by EndoPAT2000

  as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function

  baseline (before smoking narghile)

• POST - Endothelial Function as assessed by EndoPAT2000

  as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function

  after 30 minutes of smoking narghile

Secondary Outcomes (8)

• carboxy- hemoglobin

  before and immediatly after 30 min of smoking

• heart rate

  before and immediatly after 30 min of smoking

• Visual Analog Score 1-10 (1=bad 10=good)

  before and immediatly after 30 min of smoking

• Respiratory Rate

  before and immediatly after 30 min of smoking

• Spirometry

  before and immediatly after 30 min of smoking

Study Arms (1)

All participants

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

Other: Smoking Narghile for 30 min

Interventions

Smoking Narghile for 30 min OTHER

No Other intervention will be used

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 18 Y.O.
• Have smoked Water-pipe at least once before.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 32000, Israel

Location

Related Publications (1)

• Bentur L, Hellou E, Goldbart A, Pillar G, Monovich E, Salameh M, Scherb I, Bentur Y. Laboratory and clinical acute effects of active and passive indoor group water-pipe (narghile) smoking. Chest. 2014 Apr;145(4):803-809. doi: 10.1378/chest.13-0960.

  PMID: 24158379 DERIVED

MeSH Terms

Conditions

Water Pipe Smoking

Condition Hierarchy (Ancestors)

Pipe Smoking; Smoking; Behavior

Study Officials

• Lea Bentur, Prof

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 9, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

IL (1)