Lung Elastrosonography in Diagnosis and Stratification of COPD and Fibrosis

NCT04149652 | Completed

• 1 other identifier: 614/2018/DISP/AOUPR
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease; Smoker Lung

Keywords

elastography; ultrasound; copd; smoke; lung stiffness; lung ultrasound

Outcome Measures

Primary Outcomes (2)

• Elasticity score of lung parenchyma

  Qualitative index of elasticity measured by lung ultrasonography (visual score ranging from 1 to 3, 1=elastic pattern 3=rigid pattern)

  The same moment of baseline evaluation

• Strain index of lung parenchyma

  Quantitative index of stiffness of lung parenchyma measured by lung ultrasonography (percentage of stiffness ranging from 0% to 100%, with 100% representing extreme rigidity)

  The same moment of baseline evaluation

Study Arms (3)

Patients with COPD or fibrosis

OTHER

Subjects, enrolled on either an inpatient or outpatient basis, with stable COPD or fibrosis documented by anamnestic, imaging and functional tests. They will undergo lung function tests and bedside lung ultrasound integrated with lung elastosonography.

Diagnostic Test: Lung Elastosonography

Smokers with no signs of COPD

OTHER

Subjects with an active smoking habit or a personal history of hard smoking dating back to maximum 5 years before, without clinical and functional signs of COPD. They will undergo lung function tests and bedside lung ultrasound integrated with lung elastosonography.

Diagnostic Test: Lung Elastosonography

Healthy non-smoking volunteers

OTHER

Healthy volunteers who have never smoked and who have no clinical or functional sign of COPD or other respiratory diseases. They will undergo lung function tests and bedside lung ultrasound integrated with lung elastosonography.

Diagnostic Test: Lung Elastosonography

Interventions

Lung Elastosonography DIAGNOSTIC_TEST

Bedside lung ultrasound integrated with lung elastosonography, performed by using the convex probe of an Esaote Mylab Seven ultrasound system (Esaote, Genova, Italy), equipped with the strain elastography module ElaXto©.

Also known as: Lung Elastography

Healthy non-smoking volunteers; Patients with COPD or fibrosis; Smokers with no signs of COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD/fibrosis group
• Established anamnestic record of COPD or fibrosis confirmed by imaging and functional tests
• Capacity to maintain the sitting position for chest ultrasound
• Capacity and willingness to collaborate to the execution of lung function tests
• Smoker group
• Active smoking habit or personal history of hard smoking (at least 10 cigarettes/day) in the five year period before evaluation
• Presence of a high risk of COPD according to GOLD guidelines
• No anamnestic, clinical or functional evidence of COPD
• Capacity to maintain the sitting position for chest ultrasound
• Capacity and willingness to collaborate to the execution of lung function tests
• Healthy non-smoking volunteer group
• Absence of a current or past smoking habit
• Absence of a high risk of COPD according to GOLD guidelines
• Capacity to maintain the sitting position for chest ultrasound
• Capacity and willingness to collaborate to the execution of lung function tests

You may not qualify if:

• Acute respiratory failure
• Cognitive impairment or dementia
• Severe motoric disability with inability to maintain the sitting position
• Lung diseases
• Severe heart failure
• Severe kidney or liver failure
• Cancer
• Severe neuromuscular diseases
• Any other condition that could represent a bias for the accuracy of results

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

UO Medicina Interna e Lungodegenza Critica, Azienda Ospedaliero-Universitaria di Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Related Publications (10)

• Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.

  PMID: 30846476 BACKGROUND

• Ticinesi A, Scarlata S, Nouvenne A, Lauretani F, Incalzi RA, Ungar A; GRETA (Gruppo di Ricerca sull'Ecografia Toracica nell'Anziano) Group of the Italian Society of Gerontology and Geriatrics (SIGG). The Geriatric Patient: The Ideal One for Chest Ultrasonography? A Review From the Chest Ultrasound in the Elderly Study Group (GRETA) of the Italian Society of Gerontology and Geriatrics (SIGG). J Am Med Dir Assoc. 2020 Apr;21(4):447-454.e6. doi: 10.1016/j.jamda.2019.06.018. Epub 2019 Aug 6.

  PMID: 31399360 BACKGROUND

• Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.

  PMID: 26033127 BACKGROUND

• Bagdonas E, Raudoniute J, Bruzauskaite I, Aldonyte R. Novel aspects of pathogenesis and regeneration mechanisms in COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 2;10:995-1013. doi: 10.2147/COPD.S82518. eCollection 2015.

  PMID: 26082624 BACKGROUND

• Lung function testing: selection of reference values and interpretative strategies. American Thoracic Society. Am Rev Respir Dis. 1991 Nov;144(5):1202-18. doi: 10.1164/ajrccm/144.5.1202. No abstract available.

  PMID: 1952453 BACKGROUND

• Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available.

  PMID: 7663792 BACKGROUND

• Meyer KC. Pulmonary fibrosis, part I: epidemiology, pathogenesis, and diagnosis. Expert Rev Respir Med. 2017 May;11(5):343-359. doi: 10.1080/17476348.2017.1312346. Epub 2017 Apr 10.

  PMID: 28345383 BACKGROUND

• Wohlgenannt S, Gehmacher O, Gehmacher U, Kopf A, Mathis G. [Sonographic findings in interstitial lung diseases]. Ultraschall Med. 2001 Feb;22(1):27-31. doi: 10.1055/s-2001-11252. German.

  PMID: 11253553 BACKGROUND

• Gennisson JL, Deffieux T, Fink M, Tanter M. Ultrasound elastography: principles and techniques. Diagn Interv Imaging. 2013 May;94(5):487-95. doi: 10.1016/j.diii.2013.01.022. Epub 2013 Apr 22.

  PMID: 23619292 BACKGROUND

• Zhang X, Osborn T, Zhou B, Meixner D, Kinnick RR, Bartholmai B, Greenleaf JF, Kalra S. Lung Ultrasound Surface Wave Elastography: A Pilot Clinical Study. IEEE Trans Ultrason Ferroelectr Freq Control. 2017 Sep;64(9):1298-1304. doi: 10.1109/TUFFC.2017.2707981.

  PMID: 28866480 BACKGROUND

Related Links

• GOLD Guidelines 2019

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiziana Meschi, MD

  Azienda Ospedaliero-Universitaria di Parma (Parma University Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatric-Rehabilitation Department, Associate Professor of Internal Medicine

Model Details: Experimental study of feasibility of an ultrasound technique for diagnostic purposes

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: April 5, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)