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Impact of Current Smoking in the Tolerance of Bronchoscopy

This study has been terminated.
(the physician responsable for this protocol left our hospital)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345383
First Posted: May 2, 2011
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
  Purpose
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.

Condition Intervention
Smokers Procedure: bronchoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Current Smoking in the Tolerance of Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • cough [ Time Frame: Day 1 ]
    number of cough episodes during the bronchoscopy


Secondary Outcome Measures:
  • dyspnea [ Time Frame: day 1 ]
    dyspnea evaluation before and during the bronchoscopy

  • Lidocaine volume [ Time Frame: day 1 ]
    Volume of local anesthesic needed during bronchoscopy

  • length of bronchoscopy [ Time Frame: Day 1 ]
    length of bronchoscopy

  • desaturation episodes [ Time Frame: day 1 ]
    desaturation episodes during bronchoscopy


Enrollment: 100
Study Start Date: June 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Current smokers Procedure: bronchoscopy
Routine bronchoscopy under local anesthesia (lidocain). Duration: +/- 10 min

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Current and regular smokers needing a bronchoscopy as determined by their own physician
Criteria

Inclusion Criteria:

  • current and regular smoker
  • bronchoscopy under local anesthesia

Exclusion Criteria:

  • patients needing EBUS or fluoroscopy
  • intravenous sedative
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345383


Locations
Belgium
CHU Saint Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Isabelle De Meulder, MD Centre Hospitalier Universitaire Saint Pierre
  More Information

Responsible Party: Marie Bruyneel, Chef de clinique adjoint, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01345383     History of Changes
Other Study ID Numbers: AK/10-05-3898/38
First Submitted: April 28, 2011
First Posted: May 2, 2011
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre:
smoking
bronchoscopy
cough