Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533371
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Clinical-ultrasonographic Assessment of Pulmonary Emphysema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Pulmonary EmphySema the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESCULAPIO
Brief Summary:
The goal of this clinical trial is to identify correlations among data deriving from lung ultrasonographic LUS and tomographic evaluations of patients with panlobular or paraseptal emphysema to improve the comprehension of acoustic information derived from ultrasound evaluation
The main question it aims to answer is what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography HRCT of the chest in patients affected with variable degree of panlobular or paraseptal emphysema Researchers will compare LUS patterns observed in 1 COPD patients with CT evidence of panlobular or paraseptal emphysema 2 subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema and 3 patients with suspectedknown lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema
Participants will undergo LUS evaluation with both clinical and research scanners Patients will be assessed in supine position with the arms extended above the head The position is the same in which chest CT scans will be performed LUS assessment will be performed using commercially available linear probes
Finally all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry Tidal breathing analysis with impulse oscillometry IOS has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD
The main question it aims to answer is what are the correlations between thoracic ultrasonographic patterns and peripheral parenchymal changes evaluated by high resolution computed tomography HRCT of the chest in patients affected with variable degree of panlobular or paraseptal emphysema Researchers will compare LUS patterns observed in 1 COPD patients with CT evidence of panlobular or paraseptal emphysema 2 subjects participating in the screening program for lung cancer with CT evidence of panlobular or paraseptal emphysema and 3 patients with suspectedknown lung cancer undergoing with CT evidence of panlobular or paraseptal emphysema with the ones obtained from healthy volunteers and subjects who participate in the screening program for lung cancer with no evidence of emphysema
Participants will undergo LUS evaluation with both clinical and research scanners Patients will be assessed in supine position with the arms extended above the head The position is the same in which chest CT scans will be performed LUS assessment will be performed using commercially available linear probes
Finally all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo respiratory oscillometry Tidal breathing analysis with impulse oscillometry IOS has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD
Detailed Description:
The use of lung ultrasound LUS is instrumental in the evaluation of many thoracic diseases and its ability to detect pleural-pulmonary pathologies is widely accepted However the use of LUS as an indication of underlying parenchymal lung disease when the organ is still aerated is a relatively new application A-lines and B-lines are two separate and distinct artifacts which may be seen during the examination of the nonconsolidated lungs by ultrasound because of different underlying structures Even though the practical role of LUS artifacts is accepted for detecting and monitoring many conditions we do not fully understand their origin The artifactual information beyond the pleura line in LUS images of the normal and of the not critically deflated lung represents the ultimate outcome of complex interactions of a specific acoustic wave with a specific three-dimensional structure of the biological tissue
Chronic obstructive pulmonary disease COPD is a complex condition with a wide spectrum of clinical presentations and pathological features unified under the spirometric definition of airflow obstruction The mechanisms responsible for airflow obstruction in COPD airway narrowing and parenchymal destruction cannot be distinguished by standard spirometry
Chest computed tomography CT allows to depict and measure in vivo the lung pathologic changes of COPD by quantifying parenchymal destruction the direct sign of emphysema Although quantitative and qualitative studies have shown that CT can allow distinguishing subtypes of emphysema a widespread routine use of CT for the assessment of COPD in clinical practice cannot be currently foreseen due to radiation exposure and limited instrumental availability
LUS can detect pleural-pulmonary pathologies However the use of LUS as an indication of underlying parenchymal lung disease when the organ is still aerated as in emphysema is a new application
This study is aimed at researching correlations among a pool of data deriving from ultrasonographic and tomographic evaluations of patients with panlobular or paraseptal emphysema to improve the comprehension of acoustic information derived from ultrasound evaluation
The study will not modify the diagnostic therapeutic process of the enrolled patients who will all have in common the CT evidence of panlobular or paraseptal emphysema
Researchers will observe three defined population of patients at a single point at the time of enrolment All subjects will have CT evidence of panlobular or paraseptal emphysema Patients will be recruited through three paths 1 patients suffered from COPD in follow-up at Pulmonary Medicine Units in Rome and Naples with HRCT evidence of paraseptal or panlobular emphysema 2 subjects who participate in the screening program for lung cancer in Rome Naples and Acquaviva delle Fonti and 3 patients with suspectedknown lung cancer managed in all medical Units involved in this project
All enrolled subjects will undergo LUS evaluation with both clinical and research scanners Patients will be assessed in supine position with the arms extended above the head The position is the same in which chest CT scans will be performed LUS assessment will be performed using commercially available linear probes
Finally all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo oscillometry Tidal breathing analysis with impulse oscillometry IOS has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD IOS is almost independent of patient cooperation and can test a larger patient range than spirometry alone including geriatric patients
Chronic obstructive pulmonary disease COPD is a complex condition with a wide spectrum of clinical presentations and pathological features unified under the spirometric definition of airflow obstruction The mechanisms responsible for airflow obstruction in COPD airway narrowing and parenchymal destruction cannot be distinguished by standard spirometry
Chest computed tomography CT allows to depict and measure in vivo the lung pathologic changes of COPD by quantifying parenchymal destruction the direct sign of emphysema Although quantitative and qualitative studies have shown that CT can allow distinguishing subtypes of emphysema a widespread routine use of CT for the assessment of COPD in clinical practice cannot be currently foreseen due to radiation exposure and limited instrumental availability
LUS can detect pleural-pulmonary pathologies However the use of LUS as an indication of underlying parenchymal lung disease when the organ is still aerated as in emphysema is a new application
This study is aimed at researching correlations among a pool of data deriving from ultrasonographic and tomographic evaluations of patients with panlobular or paraseptal emphysema to improve the comprehension of acoustic information derived from ultrasound evaluation
The study will not modify the diagnostic therapeutic process of the enrolled patients who will all have in common the CT evidence of panlobular or paraseptal emphysema
Researchers will observe three defined population of patients at a single point at the time of enrolment All subjects will have CT evidence of panlobular or paraseptal emphysema Patients will be recruited through three paths 1 patients suffered from COPD in follow-up at Pulmonary Medicine Units in Rome and Naples with HRCT evidence of paraseptal or panlobular emphysema 2 subjects who participate in the screening program for lung cancer in Rome Naples and Acquaviva delle Fonti and 3 patients with suspectedknown lung cancer managed in all medical Units involved in this project
All enrolled subjects will undergo LUS evaluation with both clinical and research scanners Patients will be assessed in supine position with the arms extended above the head The position is the same in which chest CT scans will be performed LUS assessment will be performed using commercially available linear probes
Finally all COPD patients and subjects who participate in the screening program for lung cancer with CT evidence of paraseptal or panlobular emphysema will undergo oscillometry Tidal breathing analysis with impulse oscillometry IOS has proven to be an informative and meaningful tool used in the early detection and follow up of pulmonary diseases like COPD IOS is almost independent of patient cooperation and can test a larger patient range than spirometry alone including geriatric patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None