Tracheal Mechanics During Bronchoscopy | NCT00536315

Studies
Tracheal Mechanics During Bronchoscopy

NCT00536315

Sponsor

Beth Israel Deaconess Medical Center

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

145Actual

Phase

Not provided

Conditions

Tracheomalacia
Tracheobronchomalacia

Interventions

Not provided

Countries

United States

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

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 1999Actual

Primary Completion Date

Jul 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 26, 2007

First Submission Date that Met QC Criteria

Sep 26, 2007

First Posted Date

Sep 27, 2007Estimated

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 8, 2017

Last Update Posted Date

Mar 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen Loring, Professor of Anaesthesia, Beth Israel Deaconess Medical CenterPrincipal Investigator

Lead Sponsor

Beth Israel Deaconess Medical CenterOTHER

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 main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.

Detailed Description

This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.

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

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD		Patients with cough and/or shortness of breath who may have windpipe collapse.
Healthy adults		Subjects without symptoms for comparison.
Tracheomalacia		Patients with cough and/or shortness of breath who may have windpipe collapse.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspicion of tracheal collapse undergoing bronchoscopy
Healthy control subject undergoing bronchoscopy for another purpose.

Exclusion Criteria:

Esophageal pathology
Tracheostomy
inability to follow commands

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen H Loring, M.D.	Beth Israel Deaconess Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02215	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17426218	Result	Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24. doi: 10.1378/chest.06-2556.

ID	Term
D055090	Tracheomalacia
D055089	Tracheobronchomalacia
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D002357	Cartilage Diseases
D009140	Musculoskeletal Diseases
D014133	Tracheal Diseases
D012140	Respiratory Tract Diseases