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Impact of Current Smoking in the Tolerance of Bronchoscopy

This study is currently recruiting participants.
Verified December 2012 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01345383
First received: April 28, 2011
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Cough Smoking
U.S. FDA Resources

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

Primary Outcome Measures:
  • cough [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    number of cough episodes during the bronchoscopy


Secondary Outcome Measures:
  • dyspnea [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    dyspnea evaluation before and during the bronchoscopy

  • Lidocaine volume [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Volume of local anesthesic needed during bronchoscopy

  • length of bronchoscopy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    length of bronchoscopy

  • desaturation episodes [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    desaturation episodes during bronchoscopy


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345383

Contacts
Contact: Isabelle De Meulder, MD 3225354244 isabelle_demeulder@stpierre-bru.be
Contact: Marie Bruyneel, MD 3225354219 marie_bruyneel@stpierre-bru.be

Locations
Belgium
CHU Saint Pierre Recruiting
Brussels, Belgium, 1000
Contact: isabelle De meulder, MD     3225354244     isabelle_demeulder@stpierre-bru.be    
Principal Investigator: Isabelle de meulder, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Isabelle De Meulder, MD Centre Hospitalier Universitaire Saint Pierre
  More Information

No publications provided

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
Study First Received: April 28, 2011
Last Updated: December 12, 2012
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 19, 2013