Clinical trial NCT01237548: The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: water pipe smoking
acute effect
Endothelial
healthy adults who smoke narghile
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal People who have smoked Water-pipe, at least once before.

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.


Eligibility 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

Primary outcomes:
measure: PRE - Endothelial Function as assessed by EndoPAT2000
timeFrame: baseline (before smoking narghile)
measure: POST - Endothelial Function as assessed by EndoPAT2000
timeFrame: after 30 minutes of smoking narghile
Secondary outcomes:
measure: carboxy- hemoglobin
timeFrame: before and immediatly after 30 min of smoking
measure: heart rate
timeFrame: before and immediatly after 30 min of smoking
measure: Visual Analog Score 1-10 (1=bad 10=good)
timeFrame: before and immediatly after 30 min of smoking
measure: Respiratory Rate
timeFrame: before and immediatly after 30 min of smoking
measure: Spirometry
timeFrame: before and immediatly after 30 min of smoking
measure: Eosinophils Count
timeFrame: before and immediatly after 30 min of smoking
measure: Blood Pressure
timeFrame: before and immediatly after 30 min of smoking
measure: Exhaled Breath Condensate
timeFrame: before and immediatly after 30 min of smoking
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Lea Bentur, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.