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

NCT ID: NCT01157832

Last Updated: 2013-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carboxyhemoglobin Vital Signs Fractional Exhaled NO Exhaled Breath Condensate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lea Bentur, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RAMBAM Health Care Campus

Haifa, Israel, Israel

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20501497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20161525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19944918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18778388 (View on PubMed)

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.

Reference Type RESULT
PMID: 20414388 (View on PubMed)

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.

Reference Type RESULT
PMID: 20157455 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21030492 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMC-0219-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Measures for Bioaerosol Reduction in the Salmon Industry
NCT05039229 ENROLLING_BY_INVITATION NA