Impact of Current Smoking in the Tolerance of Bronchoscopy | NCT01345383

Studies
Impact of Current Smoking in the Tolerance of Bronchoscopy

NCT01345383

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Terminated

Last Update Posted

Mar 10, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Smokers

Interventions

bronchoscopy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the physician responsable for this protocol left our hospital

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Apr 28, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2015

Last Update Posted Date

Mar 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Bruyneel, Chef de clinique adjoint, Centre Hospitalier Universitaire Saint PierrePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Saint PierreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Current smokers			Procedure: bronchoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchoscopy	Procedure	Routine bronchoscopy under local anesthesia (lidocain). Duration: +/- 10 min	Current smokers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cough	number of cough episodes during the bronchoscopy	Day 1

Secondary Outcomes

Measure	Description	Time Frame
dyspnea	dyspnea evaluation before and during the bronchoscopy	day 1
Lidocaine volume	Volume of local anesthesic needed during bronchoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current and regular smoker
bronchoscopy under local anesthesia

Exclusion Criteria:

patients needing EBUS or fluoroscopy
intravenous sedative

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Isabelle De Meulder, MD	Centre Hospitalier Universitaire Saint Pierre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint Pierre		Brussels		1000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D012907	Smoking
D003371	Cough

Ancestor Terms

ID	Term
D001519	Behavior
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001999	Bronchoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided