The Evaluation of the Acute Effect of Water-Pipe Smoking... | NCT01237548

Studies
The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System

NCT01237548

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Jun 11, 2013Estimated

Enrollment

62Actual

Phase

Not provided

Conditions

Healthy

Interventions

Smoking Narghile for 30 min

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 3, 2010

First Submission Date that Met QC Criteria

Nov 8, 2010

First Posted Date

Nov 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath condensate (EBC) and pulmonary function tests in healthy volunteers.

Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy volunteers.

Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile smoking. The changes in inflammatory parameters pre and post smoking will be evaluated blindly.

Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile . Intervention: Each subject will undergo evaluation including a respiratory questionnaire, endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes narghile smoking.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All participants		Normal People who have smoked Water-pipe, at least once before.	Other: Smoking Narghile for 30 min

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Smoking Narghile for 30 min	Other	No Other intervention will be used	All participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PRE - Endothelial Function as assessed by EndoPAT2000	as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function	baseline (before smoking narghile)
POST - Endothelial Function as assessed by EndoPAT2000	as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function	after 30 minutes of smoking narghile

Secondary Outcomes

Measure	Description	Time Frame
carboxy- hemoglobin	Blood Test	before and immediatly after 30 min of smoking
heart rate	Heart Beats count	before and immediatly after 30 min of smoking

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lea Bentur, Prof	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa		32000	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24158379	Derived	Bentur L, Hellou E, Goldbart A, Pillar G, Monovich E, Salameh M, Scherb I, Bentur Y. Laboratory and clinical acute effects of active and passive indoor group water-pipe (narghile) smoking. Chest. 2014 Apr;145(4):803-809. doi: 10.1378/chest.13-0960.

ID	Term
D000073868	Pipe Smoking
D012907	Smoking
D001519	Behavior