Pressure Dependent Tracheal Obstruction in Copd Patients (PDTO)

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ClinicalTrials.gov Identifier: NCT01679808

Recruitment Status : Completed

First Posted : September 6, 2012

Last Update Posted : September 6, 2012

Sponsor:

Information provided by (Responsible Party):

LHL Helse

Study Description

Brief Summary:

Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).

Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.

Condition or disease
Tracheobronchomalacia

Study Design


Study Type :	Observational
Actual Enrollment :	104 participants
Observational Model:	Case-Only
Time Perspective:	Cross-Sectional
Official Title:	Pressure Dependent Tracheal Obstruction in Copd Patients
Study Start Date :	August 2004
Actual Primary Completion Date :	August 2006
Actual Study Completion Date :	August 2011

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Tracheobronchomalacia

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients (both sexes) in a pulmonary rehabilitation clinic

Criteria

Inclusion Criteria:

copd

Exclusion Criteria:

clinical evidence of malignant disease
not able to be subjected to bronchoscopy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679808

Locations


Norway
Glittreklinikken
Hakadal, Akershus, Norway, 1485

Sponsors and Collaborators

LHL Helse

Investigators


Principal Investigator:	Ivar Ellingsen, Dr med	LHL Helse

More Information


Responsible Party:	LHL Helse
ClinicalTrials.gov Identifier:	NCT01679808 History of Changes
Other Study ID Numbers:	GK-18 s-04058c ( Registry Identifier: The National Committees for Research Ethics in Norway )
First Posted:	September 6, 2012 Key Record Dates
Last Update Posted:	September 6, 2012
Last Verified:	September 2012

Keywords provided by LHL Helse:


copd airway obstruction Tracheobronchomalacia

Additional relevant MeSH terms:


Tracheobronchomalacia Cartilage Diseases Musculoskeletal Diseases Bronchial Diseases Respiratory Tract Diseases	Tracheal Diseases Musculoskeletal Abnormalities Congenital Abnormalities Connective Tissue Diseases

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