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

Vital Signs Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157832
• Other study ID #: RMC-0219-09
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: June 10, 2013
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2013
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: ISRAEL: Rambam Health Care Campus
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	RAMBAM Health Care Campus	Haifa
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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