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Completed

NCT Number: NCT01922180

Chronic Obstructive Pulmonary Disease: CT Features of Severe Exacerbation

To describe Computed Tomography (CT) features associated with severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme University Hospital

Brussels, Brussels Capital, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe exacerbation episode of COPD, requiring hospital admission

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Chest CT scans

Radiation

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 14, 2013
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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