NCT01345383

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

April 28, 2011

Last Update Submit

March 9, 2015

Conditions

Smokers

Keywords

smokingbronchoscopycough

Outcome Measures

Primary Outcomes (1)

  • cough

    number of cough episodes during the bronchoscopy

    Day 1

Secondary Outcomes (4)

  • dyspnea

    day 1

  • Lidocaine volume

    day 1

  • length of bronchoscopy

    Day 1

  • desaturation episodes

    day 1

Study Arms (1)

Current smokers

Procedure: bronchoscopy

Interventions

bronchoscopyPROCEDURE

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

Current smokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current and regular smokers needing a bronchoscopy as determined by their own physician

You may qualify if:

  • current and regular smoker
  • bronchoscopy under local anesthesia

You may not qualify if:

  • patients needing EBUS or fluoroscopy
  • intravenous sedative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

SmokingCough

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

BehaviorRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Isabelle De Meulder, MD

    Centre Hospitalier Universitaire Saint Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de clinique adjoint

Study Record Dates

First Submitted

April 28, 2011

First Posted

May 2, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

BE(1)