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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01345383
Other study ID # AK/10-05-3898/38
Secondary ID
Status Terminated
Phase N/A
First received April 28, 2011
Last updated March 9, 2015
Start date June 2010
Est. completion date August 2013

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- current and regular smoker

- bronchoscopy under local anesthesia

Exclusion Criteria:

- patients needing EBUS or fluoroscopy

- intravenous sedative

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
bronchoscopy
Routine bronchoscopy under local anesthesia (lidocain). Duration: +/- 10 min

Locations

Country Name City State
Belgium CHU Saint Pierre Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary cough number of cough episodes during the bronchoscopy Day 1 No
Secondary dyspnea dyspnea evaluation before and during the bronchoscopy day 1 No
Secondary Lidocaine volume Volume of local anesthesic needed during bronchoscopy day 1 No
Secondary length of bronchoscopy length of bronchoscopy Day 1 No
Secondary desaturation episodes desaturation episodes during bronchoscopy day 1 No
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