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Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Rambam Health Care Campus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01157832
First received: July 6, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) pulmonary function tests in healthy volunteers

Objectives: To evaluate the acute effect of one cession of water pipe smoking on airway inflammation as assessed by exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) in healthy volunteers.

Design: Prospective study evaluating these parameters before and after 30 minutes of water pipe smoking . The changes in inflammatory parameters pre and post smoking will be evaluated blindly.

Sample size: 100 participants Participant selection: Adults subjects who regularly smoke water pipe . Intervention: Each subject will undergo evaluation including a respiratory questionnaire , pulmonary function tests , exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes water pipe smoking

Primary outcome parameter: Change in carboxy- hemoglobin Secondary outcome parameter:Change in peripheral eosinophils count, pulmonary function tests, change in FeNO, and in inflammatory parameters in EBC before and after water pipe smoking


Condition
Carboxyhemoglobin
Vital Signs
Fractional Exhaled NO
Exhaled Breath Condensate

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

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


Secondary Outcome Measures:
  • Eosinophils count [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    blood test

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

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

  • Blood pressure [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Non Invasive Blood pressure mesaurement

  • Spirometry [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Pulmonary function test

  • 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

  • Exhaled breath Condensate [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    R-tube tests

  • Fractional Exhaled NO [ Time Frame: before and immediatly after 30 min of smoking ] [ Designated as safety issue: No ]
    Exhaled NO test


Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
  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: NCT01157832

Locations
Israel
Rambam Medical Center
Haifa, Israel
RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Lea Bentur, Prof. Rambam Health Care Campus
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Lea Bentur, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01157832     History of Changes
Other Study ID Numbers: RMC-0219-09
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: ISRAEL: Rambam Health Care Campus

Keywords provided by Rambam Health Care Campus:
water pipe smoking acute effect

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 23, 2013