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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01157832

Enrollment

Registered

2010-07-07

Start date

2009-11-30

Completion date

2010-08-31

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carboxyhemoglobin, Exhaled Breath Condensate, Fractional Exhaled NO, Vital Signs

Keywords

water pipe smoking acute effect

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
carboxy- hemoglobin	before and immediatly after 30 min of smoking	blood test

Secondary

Measure	Time frame	Description
heart rate	before and immediatly after 30 min of smoking	heart beats count
Respiratory rate	before and immediatly after 30 min of smoking	Respiratory rate
Blood pressure	before and immediatly after 30 min of smoking	Non Invasive Blood pressure mesaurement
Eosinophils count	before and immediatly after 30 min of smoking	blood test
Visual Analog Score 1-10 (1=bad 10=good)	before and immediatly after 30 min of smoking	Questionnaire
Exhaled breath Condensate	before and immediatly after 30 min of smoking	R-tube tests
Fractional Exhaled NO	before and immediatly after 30 min of smoking	Exhaled NO test
Spirometry	before and immediatly after 30 min of smoking	Pulmonary function test

Countries

Israel

Outcome results