Chronic Obstructive Pulmonary Disease: CT Features of Severe Exacerbation

COPD Exacerbation Clinical Trial

Official title:

Chronic Obstructive Pulmonary Disease: CT Features of Severe Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922180
• Other study ID #: COPD-EXAC-CT
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: August 13, 2013
• Start date: July 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2013
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Severe exacerbation episode of COPD, requiring hospital admission

Exclusion Criteria:

• No exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD Exacerbation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Hansell DM, Bankier AA, MacMahon H, McLoud TC, Müller NL, Remy J. Fleischner Society: glossary of terms for thoracic imaging. Radiology. 2008 Mar;246(3):697-722. doi: 10.1148/radiol.2462070712. Epub 2008 Jan 14. — View Citation

Myint PK, Lowe D, Stone RA, Buckingham RJ, Roberts CM. U.K. National COPD Resources and Outcomes Project 2008: patients with chronic obstructive pulmonary disease exacerbations who present with radiological pneumonia have worse outcome compared to those with non-pneumonic chronic obstructive pulmonary disease exacerbations. Respiration. 2011;82(4):320-7. doi: 10.1159/000327203. Epub 2011 May 20. — View Citation

Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. Review. — View Citation

Rutschmann OT, Cornuz J, Poletti PA, Bridevaux PO, Hugli OW, Qanadli SD, Perrier A. Should pulmonary embolism be suspected in exacerbation of chronic obstructive pulmonary disease? Thorax. 2007 Feb;62(2):121-5. Epub 2006 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest CT scan features at 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.	4 hours	No
Primary	Chest CT scan features at control	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	No
Secondary	PFT at control	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	No
Secondary	PFT at 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).	4 hours	No