Pressure Dependent Tracheal Obstruction in Copd Patients (PDTO)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

LHL Helse

ClinicalTrials.gov Identifier:

NCT01679808

First received: September 3, 2012

Last updated: NA

Last verified: September 2012

History: No changes posted

Purpose

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
Tracheobronchomalacia


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	Pressure Dependent Tracheal Obstruction in Copd Patients

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Tracheobronchomalacia

U.S. FDA Resources

Further study details as provided by LHL Helse:


Enrollment:	104
Study Start Date:	August 2004
Study Completion Date:	August 2011
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 )
Study First Received:	September 3, 2012
Last Updated:	September 3, 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

ClinicalTrials.gov processed this record on June 22, 2017

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