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Completed

NCT Number: NCT01157832

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

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

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Key information

Conditions

Carboxyhemoglobin Exhaled Breath Condensate Fractional Exhaled NO Vital Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RAMBAM Health Care Campus, Haifa, Israel

Loading trial locations.

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

Primary outcomes

  1. carboxy- hemoglobin

    Time frame: before and immediatly after 30 min of smoking

    blood test

Secondary outcomes

  1. Eosinophils count

    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. Respiratory rate

    Time frame: before and immediatly after 30 min of smoking

    Respiratory rate

  4. Blood pressure

    Time frame: before and immediatly after 30 min of smoking

    Non Invasive Blood pressure mesaurement

  5. Spirometry

    Time frame: before and immediatly after 30 min of smoking

    Pulmonary function test

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

    Time frame: before and immediatly after 30 min of smoking

    Questionnaire

  7. Exhaled breath Condensate

    Time frame: before and immediatly after 30 min of smoking

    R-tube tests

  8. Fractional Exhaled NO

    Time frame: before and immediatly after 30 min of smoking

    Exhaled NO test

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 7, 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.

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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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