Role of Lung Ultrasonography for Detecting COPD and Fibrosis and Stratifying the Risk of COPD in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Strain index of lung parenchyma
研究概览
简要总结
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).
详细描述
Introduction
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by irreversible expiratory airflow limitation with bronchial hyperinflation and air trapping, causing a reduction of pulmonary and thoracic compliance, characterized by chronic inflammation with emphysematous destruction of the lungs (GOLD Guidelines 2019; Singh P et al 2019; Bagdonas E et al 2015).
In the last decade, bedside lung ultrasonography (LUS) has rapidly gained popularity for the differential diagnosis of respiratory diseases, especially in the acute setting, for its accuracy, repeatability, rapidity and versatility that make it the ideal diagnostic tool in the internal medicine and geriatric setting (Ticinesi A et al 2019).
COPD is not associated with any specific sign at LUS, so that, in a context of acute exacerbation with respiratory failure, it remains a diagnosis of exclusion (Lichtenstein D 2015). Instead, lung function tests (i.e., spirometry) is considered the gold standard test for COPD detection (GOLD Guidelines 2019).
However, spirometry suffers from some limits, the major being its dependence on the cooperation of the subject, because during the test it is necessary to perform a correct expiratory forced manoeuvre with restricted acceptability standards (American Thoracic Society 1991; American Toracic Society 1995). As such, it can not be perfomed in patients with severe cognitive and physical impairment. Furthermore, spirometry is contraindicated in many conditions which may be aggravated by the effort (i.e. unstable cardiovascular status, recent myocardial infarction, pulmonary embolism and other) (American Association for Respiratory Care 1996). Alternative methods of identification of COPD and stratification of its risk in clinical practice are thus highly desirable, but unavailable to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Severe neuromuscular diseases
- •Any other condition that could represent a bias for the accuracy of results
结局指标
主要结局
Strain index of lung parenchyma
时间窗: The same moment of baseline evaluation
Quantitative index of stiffness of lung parenchyma measured by lung ultrasonography (percentage of stiffness ranging from 0% to 100%, with 100% representing extreme rigidity)
Elasticity score of lung parenchyma
时间窗: The same moment of baseline evaluation
Qualitative index of elasticity measured by lung ultrasonography (visual score ranging from 1 to 3, 1=elastic pattern 3=rigid pattern)
次要结局
未报告次要终点
研究者
Tiziana Meschi
Head of Geriatric-Rehabilitation Department, Associate Professor of Internal Medicine
Azienda Ospedaliero-Universitaria di Parma