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

NCT01157832 | Completed DMC

• 1 other identifier: RMC-0219-09
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

water pipe smoking acute effect

Outcome Measures

Primary Outcomes (1)

• carboxy- hemoglobin

  blood test

  before and immediatly after 30 min of smoking

Secondary Outcomes (8)

• Eosinophils count

  before and immediatly after 30 min of smoking

• heart rate

  before and immediatly after 30 min of smoking

• Respiratory rate

  before and immediatly after 30 min of smoking

• Blood pressure

  before and immediatly after 30 min of smoking

• Spirometry

  before and immediatly after 30 min of smoking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal People who have smoked Water-pipe, at least once before.

You may qualify if:

• Age \> 18 Y.O.
• Have smoked Water-pipe at least once before.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (2)

RAMBAM Health Care Campus

Haifa, Israel, 31096, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Related Publications (7)

• 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.

  PMID: 20501497 BACKGROUND

• 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.

  PMID: 20161525 BACKGROUND

• 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.

  PMID: 19944918 BACKGROUND

• 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.

  PMID: 18778388 BACKGROUND

• 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.

  PMID: 20414388 RESULT

• 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.

  PMID: 20157455 RESULT

• 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.

  PMID: 21030492 DERIVED

Study Officials

• Lea Bentur, Prof.

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 7, 2010
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 11, 2013

Record last verified: 2013-06

Locations

IL (2)