Chronic Obstructive Pulmonary Disease: CT Features of Severe Exacerbation

August 13, 2013 updated by: Maxime HACKX, Erasme University Hospital
To describe Computed Tomography (CT) features associated with severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The natural course of COPD is associated with episodes of exacerbation which are clinically defined as acute events characterized by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and which leads to a change in medication. Moreover, these episodes can be classified into mild, moderate, or severe exacerbations, following patient's need for medical environment. While the cause of about one-third of severe exacerbation episodes cannot be identified, two-thirds are associated with certain conditions such as respiratory tract infections (viral or bacterial), air pollution, as well as pulmonary embolism (PE), pulmonary edema, cardiac arrhythmia, pneumothorax, or pleural effusion. As COPD exacerbations are associated with increased morbidity and mortality, as well as with increased healthcare costs, their prevention and treatment are two major objectives in COPD management with subsequent requirement for appropriate assessment tools. As imaging tool, chest radiography is limited to the detection of pneumonia and pleural abnormalities, and only leads to change in managements in a marginal proportion of patients. However, while Computed Tomography (CT) scans allows detecting more chest abnormalities, the knowledge of CT features at the time of exacerbation is a pre-requisite for determining possible role of CT in routine work-up of exacerbation. Nevertheless these features remain widely unknown, previous studies having focused on the prevalence of PE. The aim of our study was therefore to describe these features by comparing CT scans performed at severe exacerbation with control scans.

Study Type

Observational

Enrollment (Actual)

44

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

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients followed in our institution (i.e. Erasme University Hospital), who are admitted for a severe exacerbation episode.

Description

Inclusion Criteria:

  • Severe exacerbation episode of COPD, requiring hospital admission

Exclusion Criteria:

  • No exclusion criteria

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD Exacerbation
COPD patients aged 18 years or more, were included at the time of an exacerbation episode leading to admission in our hospital, which corresponds to a severe episode. There were no exclusion criteria. Patients underwent chest CT scans and PFT. After a minimum of two weeks free of any acute symptom after discharge, CT scans and PFT were redone.
Radiation: Chest CT scans
CT examinations were performed with a commercially available 64-detector row scanner. Images were acquired in supine position after full inspiration and full expiration, using the following parameters: slice thickness, 0.6 mm; pitch, 1.4; rotation time, 330 msec; tube voltage, 120 kiloVolts; and tube current-time product, 100 milliAmperes, with automatic exposure control (CareDose 4D, Siemens Healthcare) switched on. From raw data, 1-mm-thick section images were reconstructed at 0.7-mm intervals by using a high spatial algorithm and a soft-tissue algorithm. The inspiratory CT scan at the time of exacerbation was performed with intravenous iodinated contrast material, whereas the control scan was unenhanced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest CT scan features at exacerbation
Time Frame: 4 hours
Grading the severity of the following 15 features: bronchiectasis, mucous plugging, bronchial wall thickening, pulmonary consolidation, ground glass opacity, cysts or bullae, air trapping, centrilobular micronodules, platelike atelectasis, emphysema, pulmonary embolism, pleural effusion, mediastinal or hilar lymphadenopathy, reticular pattern or honeycombing, and pulmonary mass or nodule.
4 hours
Chest CT scan features at control
Time Frame: Minimum two weeks after exacerbation
Grading the severity of the following 15 features: bronchiectasis, mucous plugging, bronchial wall thickening, pulmonary consolidation, ground glass opacity, cysts or bullae, air trapping, centrilobular micronodules, platelike atelectasis, emphysema, pulmonary embolism, pleural effusion, mediastinal or hilar lymphadenopathy, reticular pattern or honeycombing, and pulmonary mass or nodule.
Minimum two weeks after exacerbation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFT at control
Time Frame: Minimum two weeks after exacerbation
Measurements of the forced vital capacity (FVC), the forced expiratory volume in one second (FEV1), the functional residual capacity (FRC), the total lung capacity (TLC) and the residual volume (RV).
Minimum two weeks after exacerbation
PFT at exacerbation
Time Frame: 4 hours
Measurements of the forced vital capacity (FVC), the forced expiratory volume in one second (FEV1), the functional residual capacity (FRC), the total lung capacity (TLC) and the residual volume (RV).
4 hours

Collaborators and Investigators

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

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPD-EXAC-CT

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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