HealthyNCT01237548
The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System
An observational study of Healthy, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Smoking Narghile for 30 min
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal People who have smoked Water-pipe, at least once before.
Who may be able to join
- Age > 18 Y.O.
- Have smoked Water-pipe at least once before.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Smoking Narghile for 30 min
- Keywords
- water pipe smoking, acute effect, Endothelial, healthy adults who smoke narghile
- Medical subject headings
- Water Pipe Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Narghile for 30 minOther
No Other intervention will be used
| Study group | Role | What they receive |
|---|---|---|
| All participants | Normal People who have smoked Water-pipe, at least once before. Receives: Other: Smoking Narghile for 30 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRE - Endothelial Function as assessed by EndoPAT2000
as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
Measured: baseline (before smoking narghile)
POST - Endothelial Function as assessed by EndoPAT2000
as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
Measured: after 30 minutes of smoking narghile
Secondary outcomes (8)
carboxy- hemoglobin
Blood Test
Measured: before and immediatly after 30 min of smoking
heart rate
Heart Beats count
Measured: before and immediatly after 30 min of smoking
Visual Analog Score 1-10 (1=bad 10=good)
Questionnaire
Measured: before and immediatly after 30 min of smoking
Respiratory Rate
Measured: before and immediatly after 30 min of smoking
Spirometry
Koko spirometry system
Measured: before and immediatly after 30 min of smoking
Eosinophils Count
Blood Test
Measured: before and immediatly after 30 min of smoking
Blood Pressure
Regular Blood Pressure assesment
Measured: before and immediatly after 30 min of smoking
Exhaled Breath Condensate
R-tubes test
Measured: before and immediatly after 30 min of smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Bentur, Prof, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237548
- Sponsor's protocol ID
- Narghile Endotheil RMC 284
- Status last verified
- Jun 2013
- First submitted
- 3 Nov 2010
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24158379
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System
- ClinicalTrials.gov ID
- NCT01237548
- Acronym / sponsor ID
- Narghile Endotheil RMC 284
- Conditions
- Healthy
- Keywords
- water pipe smoking, acute effect, Endothelial, healthy adults who smoke narghile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: Smoking Narghile for 30 minNormal People who have smoked Water-pipe, at least once before. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal People who have smoked Water-pipe, at least once before.
Key inclusion criteria (2 listed)
- Age > 18 Y.O.
- Have smoked Water-pipe at least once before.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Narghile for 30 minNo Other intervention will be used | Other | All participants |
Primary outcome
PRE - Endothelial Function as assessed by EndoPAT2000
Time frame: baseline (before smoking narghile)
as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
POST - Endothelial Function as assessed by EndoPAT2000
Time frame: after 30 minutes of smoking narghile
as assessed by EndoPAT2000. a pulse-oxymeter that asseses the endothelial function
8 secondary outcomes
carboxy- hemoglobin
Time frame: before and immediatly after 30 min of smoking
heart rate
Time frame: before and immediatly after 30 min of smoking
Visual Analog Score 1-10 (1=bad 10=good)
Time frame: before and immediatly after 30 min of smoking
Respiratory Rate
Time frame: before and immediatly after 30 min of smoking
Spirometry
Time frame: before and immediatly after 30 min of smoking
Eosinophils Count
Time frame: before and immediatly after 30 min of smoking
Blood Pressure
Time frame: before and immediatly after 30 min of smoking
Exhaled Breath Condensate
Time frame: before and immediatly after 30 min of smoking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 24158379Bentur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Bentur, Prof principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRE - Endothelial Function as assessed by EndoPAT2000 (time frame: baseline (before smoking narghile)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.