- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01157832
Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System
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
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
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Haifa, Israel, 31096
- Rambam Health Care Campus
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Haifa, Israel
- Rambam Medical Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
carboxy- hemoglobin
Tidsram: before and immediatly after 30 min of smoking
|
blood test
|
before and immediatly after 30 min of smoking
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Eosinophils count
Tidsram: before and immediatly after 30 min of smoking
|
blood test
|
before and immediatly after 30 min of smoking
|
heart rate
Tidsram: before and immediatly after 30 min of smoking
|
heart beats count
|
before and immediatly after 30 min of smoking
|
Respiratory rate
Tidsram: before and immediatly after 30 min of smoking
|
Respiratory rate
|
before and immediatly after 30 min of smoking
|
Blood pressure
Tidsram: before and immediatly after 30 min of smoking
|
Non Invasive Blood pressure mesaurement
|
before and immediatly after 30 min of smoking
|
Spirometry
Tidsram: before and immediatly after 30 min of smoking
|
Pulmonary function test
|
before and immediatly after 30 min of smoking
|
Visuell analog poäng 1-10 (1=dålig 10=bra)
Tidsram: före och omedelbart efter 30 min rökning
|
Frågeformulär
|
före och omedelbart efter 30 min rökning
|
Exhaled breath Condensate
Tidsram: before and immediatly after 30 min of smoking
|
R-tube tests
|
before and immediatly after 30 min of smoking
|
Fractional Exhaled NO
Tidsram: before and immediatly after 30 min of smoking
|
Exhaled NO test
|
before and immediatly after 30 min of smoking
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lea Bentur, Prof., Rambam Health Care Campus
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- RMC-0219-09
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