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NCT01679808 Clinical Trial

Pressure Dependent Tracheal Obstruction in Copd Patients

Tracheobronchomalacia Clinical Trial

— PDTO  

Official title:
Pressure Dependent Tracheal Obstruction in Copd Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01679808
Other study ID # GK-18
Secondary ID s-04058c
Status Completed
Phase N/A
First received September 3, 2012
Last updated September 3, 2012
Start date August 2004
Est. completion date August 2011

Study information
Verified date September 2012
Source LHL Helse
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date August 2011
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- copd

Exclusion Criteria:

- clinical evidence of malignant disease

- not able to be subjected to bronchoscopy

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Glittreklinikken Hakadal Akershus

Sponsors (1)
Lead Sponsor Collaborator
LHL Helse

Country where clinical trial is conducted

Norway, 

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