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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:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01345383
First received: April 28, 2011
Last updated: September 4, 2013
Last verified: September 2013
  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 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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: September 4, 2013
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014