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Completed

NCT Number: NCT01237548

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.

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Key information

Conditions

Healthy Behavior Pipe Smoking Smoking Water Pipe Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Medical Center

Haifa, 32000, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking Narghile for 30 min

Other

No Other intervention will be used

Primary outcomes

  1. PRE - Endothelial Function as assessed by EndoPAT2000

    Time frame: baseline (before smoking narghile)

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

  2. POST - Endothelial Function as assessed by EndoPAT2000

    Time frame: after 30 minutes of smoking narghile

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

Secondary outcomes

  1. carboxy- hemoglobin

    Time frame: before and immediatly after 30 min of smoking

    Blood Test

  2. heart rate

    Time frame: before and immediatly after 30 min of smoking

    Heart Beats count

  3. Visual Analog Score 1-10 (1=bad 10=good)

    Time frame: before and immediatly after 30 min of smoking

    Questionnaire

  4. Respiratory Rate

    Time frame: before and immediatly after 30 min of smoking

  5. Spirometry

    Time frame: before and immediatly after 30 min of smoking

    Koko spirometry system

  6. Eosinophils Count

    Time frame: before and immediatly after 30 min of smoking

    Blood Test

  7. Blood Pressure

    Time frame: before and immediatly after 30 min of smoking

    Regular Blood Pressure assesment

  8. Exhaled Breath Condensate

    Time frame: before and immediatly after 30 min of smoking

    R-tubes test

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2010
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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