NCT04149652: ELAS-P-1

Lung Elastrosonography in Diagnosis and Stratification of COPD and Fibrosis

Completed NA Last updated 13 January 2021

What this trial tests

NA trial testing Lung Elastosonography in Chronic Obstructive Pulmonary Disease in 66 participants. Completed in 30 December 2020.

Timeline

5 April 2019

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria di Parma
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	66
Start date	5 April 2019
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across Italy

Drugs / interventions tested

• Lung Elastosonography

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
• Smoker Lung — all drugs for Smoker Lung →

Sponsor

Azienda Ospedaliero-Universitaria di Parma — full company profile →

Who can join

18 and older, any sex, with Chronic Obstructive Pulmonary Disease or Smoker Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Elastosonography is an advanced ultrasound technique, nowadays available in many portable systems, allowing to measure elasticity and stiffness of parenchymatous organs. Its main current applications concern the advanced diagnostics of liver, thyroid and breast nodules. Few studies have applied elastosonography to the respiratory system, and to date no-one has evaluated the elasticity of lung parenchyma in COPD and only one in pulmonary fibrosis. The primary aim of this study is to compare the elasticity features of lung parenchyma, measured by bedside ultrasound integrated with ultrasonography, among three groups of subjects: 1. patients with COPD and/or lung fibrosis; 2. smokers with no functional evidence of COPD or fibrosis; 3. healthy non-smoking volunteers. The secondary aim is to verify the possible correlation of elastosonography-related parameters of lung elasticity/stiffness with results of lung function tests.

One hundred and thirty-eight subjects (46 per group) will be enrolled in this experimental study, on both inpatient and outpatient basis. The presence or absence of COPD or fibrosis will be assessed integrating personal history, imaging tests and functional tests prior to enrolment. Smoking habits will also be carefully investigated. Excluded from the study will be all subjects with acute COPD flares, acute respiratory failure, inability to undergo lung ultrasound examination and lung function tests, cognitive impairment, severe motoric disability, cancer, poor survival prognosis.

Each participant will undergo standard lung function tests and bediside ultrasound examination integrated with lung elastosonography during the same day. Lung function tests will be performed with a Carefusion MSC Body spirometer following standard procedures. Lung ultrasound will be performed by a skilled physician, using the convex probe of an Esaote Mylab Seven ultrasound system (Esaote, Genova, Italy), equipped with strain elastography module ElaXto©. The participant will remain in the sitting position for the whole ultrasound/elastography procedure, with the examiner systematically scanning intercostal spaces on both sides of the back thorax. After performing a standard lung ultrasound scan to verify the absence of consolidations or signs of respiratory diseases other than COPD, the examiner will activate the elastography module, performing little compressions with the wrist on the convex probe, to obtain adequate elastography images combining ranges of red, green and blue colors. Images will then be analyzed with the software ElaXto©, to obtain the percentage of stiffness in areas of interest of lung parenchyma.

Statistical analyses will be focused on comparison of stiffness index across different groups, and on correlation of elastosonographic parameters with lung function tests (FEV1, Tiffeneau index).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.