- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345383
Impact of Current Smoking in the Tolerance of Bronchoscopy
March 9, 2015 updated by: Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
The purpose of this study is to study the impact of smoking in the preceding hours before a bronchoscopy on the tolerance of this exam.
Study Overview
Detailed Description
Tolerance evaluation of the bronchoscopy on current and regular smokers. The investigators assess episodes of cough, dyspnea, volume of lidocain (liquid 1% and in spray 10%), duration of the procedure, episodes of desaturation and completion of the bronchoscopy.
The investigators compare patients who did not smoke in the 6 hours before the bronchoscopy and those who have smoked.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1000
- CHU Saint Pierre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Current and regular smokers needing a bronchoscopy as determined by their own physician
Description
Inclusion Criteria:
- current and regular smoker
- bronchoscopy under local anesthesia
Exclusion Criteria:
- patients needing EBUS or fluoroscopy
- intravenous sedative
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Current smokers
|
Routine bronchoscopy under local anesthesia (lidocain).
Duration: +/- 10 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cough
Time Frame: Day 1
|
number of cough episodes during the bronchoscopy
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dyspnea
Time Frame: day 1
|
dyspnea evaluation before and during the bronchoscopy
|
day 1
|
Lidocaine volume
Time Frame: day 1
|
Volume of local anesthesic needed during bronchoscopy
|
day 1
|
length of bronchoscopy
Time Frame: Day 1
|
length of bronchoscopy
|
Day 1
|
desaturation episodes
Time Frame: day 1
|
desaturation episodes during bronchoscopy
|
day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Isabelle De Meulder, MD, Centre Hospitalier Universitaire Saint Pierre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
April 28, 2011
First Submitted That Met QC Criteria
April 29, 2011
First Posted (Estimate)
May 2, 2011
Study Record Updates
Last Update Posted (Estimate)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 9, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AK/10-05-3898/38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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