Pressure Dependent Tracheal Obstruction in Copd Patients (PDTO)

September 3, 2012 updated by: LHL Helse

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Hakadal, Akershus, Norway, 1485
        • Glittreklinikken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients (both sexes) in a pulmonary rehabilitation clinic

Description

Inclusion Criteria:

  • copd

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LHL Helse

Investigators

  • Principal Investigator: Ivar Ellingsen, Dr med, LHL Helse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 3, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GK-18
  • s-04058c (Registry Identifier: The National Committees for Research Ethics in Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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