Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-26 @ 8:52 PM
Study NCT ID:
NCT01157832
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2010-07-06', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'carboxy- hemoglobin', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'blood test'}], 'secondaryOutcomes': [{'measure': 'Eosinophils count', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'blood test'}, {'measure': 'heart rate', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'heart beats count'}, {'measure': 'Respiratory rate', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'Respiratory rate'}, {'measure': 'Blood pressure', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'Non Invasive Blood pressure mesaurement'}, {'measure': 'Spirometry', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'Pulmonary function test'}, {'measure': 'Visual Analog Score 1-10 (1=bad 10=good)', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'Questionnaire'}, {'measure': 'Exhaled breath Condensate', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'R-tube tests'}, {'measure': 'Fractional Exhaled NO', 'timeFrame': 'before and immediatly after 30 min of smoking', 'description': 'Exhaled NO test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['water pipe smoking acute effect'], 'conditions': ['Carboxyhemoglobin', 'Vital Signs', 'Fractional Exhaled NO', 'Exhaled Breath Condensate']}, 'referencesModule': {'references': [{'pmid': '20501497', 'type': 'BACKGROUND', '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.'}, {'pmid': '20161525', 'type': 'BACKGROUND', '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.'}, {'pmid': '19944918', 'type': 'BACKGROUND', '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.'}, {'pmid': '18778388', 'type': 'BACKGROUND', '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.'}, {'pmid': '20414388', 'type': 'RESULT', '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.'}, {'pmid': '20157455', 'type': 'RESULT', '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.'}, {'pmid': '21030492', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Title: The acute effect of water pipe smoking on exhaled nitric oxide (eNO) and exhaled breath condensate (EBC) pulmonary function tests in healthy volunteers\n\nObjectives: 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.\n\nDesign: 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.\n\nSample 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\n\nPrimary 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal People who have smoked Water-pipe, at least once before.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 Y.O.\n* Have smoked Water-pipe at least once before.\n\nExclusion Criteria:\n\n* Breast feeding Women.\n* S/P Bacterial Or Viral infection, Last 2 weeks\n* P.O. Steroids\n* Water-pipe smoking, last 24 hours\n* Cigarette smoking, last 6 hours\n* Intensive exposure to smoke (fire), last 24 hours\n* S/P Intensive Care Hospitalization, last 3 months'}, 'identificationModule': {'nctId': 'NCT01157832', 'briefTitle': 'Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': 'RMC-0219-09'}}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'state': 'Israel', 'country': 'Israel', 'facility': 'RAMBAM Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Lea Bentur, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}