Clinical trial NCT01157832: Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carboxyhemoglobin
Vital Signs
Fractional Exhaled NO
Exhaled Breath Condensate
Keywords: water pipe smoking acute effect
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 45
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 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


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: carboxy- hemoglobin
timeFrame: before and immediatly after 30 min of smoking
Secondary outcomes:
measure: Eosinophils count
timeFrame: before and immediatly after 30 min of smoking
measure: heart rate
timeFrame: before and immediatly after 30 min of smoking
measure: Respiratory rate
timeFrame: before and immediatly after 30 min of smoking
measure: Blood pressure
timeFrame: before and immediatly after 30 min of smoking
measure: Spirometry
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: Exhaled breath Condensate
timeFrame: before and immediatly after 30 min of smoking
measure: Fractional Exhaled NO
timeFrame: before and immediatly after 30 min of smoking
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM Health Care Campus
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Lea Bentur, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakkash R, Khalil J. Health warning labelling practices on narghile (shisha, hookah) waterpipe tobacco products and related accessories. Tob Control. 2010 Jun;19(3):235-9. doi: 10.1136/tc.2009.031773.
citation: Daher N, Saleh R, Jaroudi E, Sheheitli H, Badr T, Sepetdjian E, Al Rashidi M, Saliba N, Shihadeh A. Comparison of carcinogen, carbon monoxide, and ultrafine particle emissions from narghile waterpipe and cigarette smoking: Sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmos Environ (1994). 2010 Jan 1;44(1):8-14. doi: 10.1016/j.atmosenv.2009.10.004.
citation: Eissenberg T, Shihadeh A. Waterpipe tobacco and cigarette smoking: direct comparison of toxicant exposure. Am J Prev Med. 2009 Dec;37(6):518-23. doi: 10.1016/j.amepre.2009.07.014.
citation: Maziak W. The waterpipe: time for action. Addiction. 2008 Nov;103(11):1763-7. doi: 10.1111/j.1360-0443.2008.02327.x. Epub 2008 Sep 4.
citation: Chaouachi K. Lessons from the recent case of CO poisoning due to shisha (hookah, narghile) tobacco smoking in Singapore. Int J Emerg Med. 2010 Feb 6;3(1):67-8. doi: 10.1007/s12245-009-0139-2. No abstract available.
citation: Lim BL, Lim GH, Seow E. Case of carbon monoxide poisoning after smoking shisha. Int J Emerg Med. 2009 Mar 11;2(2):121-2. doi: 10.1007/s12245-009-0097-8.
citation: Hakim F, Hellou E, Goldbart A, Katz R, Bentur Y, Bentur L. The acute effects of water-pipe smoking on the cardiorespiratory system. Chest. 2011 Apr;139(4):775-781. doi: 10.1378/chest.10-1833. Epub 2010 Oct 28.