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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
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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
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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

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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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
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Norway
Glittreklinikken
Hakadal, Akershus, Norway, 1485
Sponsors and Collaborators
LHL Helse
Investigators
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Principal Investigator: Ivar Ellingsen, Dr med LHL Helse
More Information
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Responsible Party: LHL Helse
ClinicalTrials.gov Identifier: NCT01679808    
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:
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Tracheobronchomalacia
Cartilage Diseases
Musculoskeletal Diseases
Bronchial Diseases
Respiratory Tract Diseases
 Tracheal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases