Clinical-ultrasonographic Assessment of Pulmonary Emphysema

Официальное название

Assessment of Pulmonary EmphySema: the Clinical -ULtrasonographic APproach to chronIc Obstructive Pulmonary Disease

Обзор

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 suspected/known 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.

Подробное описание

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 suspected/known 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.

Вмешательства

• Диагностический тест Relationship between lung ultrasound and computed tomographic scan
  Ultrasonographic findings will be obtained with clinical machines. Additionally, US scans as acquired with the Ula-Op open research platform will also be gathered. For both scanners, 10seconds videos will be recorded and stored in each landmark. To correlate LUS artefactual patterns with peripheral parenchymal changes evaluated by HRCT of the chest, all chest CT findings will be analysed by an image processing platform designed to provide visualization and quantification of areas with abnormal

Первичные конечные точки

• Number of participants with ultrasonographic pattern of emphysema. [Срок оценки: through study completion, an average of 2 year]

Критерии участия

Критерии включения

• outpatients in follow-up for chronic obstructive pulmonary disease, in stable conditions, with computed tomographic evidence of panlobular or paraseptal emphysema.
• Inpatients, admitted to the hospital due to acute exacerbation of chronic obstructive pulmonary disease, with computed tomographic evidence of panlobular or paraseptal emphysema.
• Subjects who participate in the screening program for lung cancer with computed tomographic evidence of panlobular or paraseptal emphysema.
• Outpatients / Inpatients with suspected/known lung cancer and computed tomographic evidence of panlobular or paraseptal emphysema.
• Patients able to give written informed consent.

Критерии исключения

• pregnancy.
• Pediatric population.
• Patients unable to express written informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Италия · 4 центра

• Ente Ecclesiastico, Ospedale Generale Regionale "F. Miulli" — Acquaviva delle Fonti
• A.O.R.N. "A. Cardarelli" — Naples
• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome
• University of Trento — Trento

Публикации

• Mento F, Perini M, Malacarne C, Demi L. Ultrasound multifrequency strategy to estimate the lung surface roughness, in silico and in vitro results. Ultrasonics. 2023 Dec;135:107143. doi: 10.1016/j.ultras.2023.107143. Epub 2023 Aug 24. PMID 37647701
• Wolfram F, Miller D, Demi L, Verma P, Moran CM, Walther M, Mathis G, Prosch H, Kollmann C, Jenderka KV. Best Practice Recommendations for the Safe use of Lung Ultrasound. Ultraschall Med. 2023 Oct;44(5):516-519. doi: 10.1055/a-1978-5575. Epub 2022 Nov 14. PMID 36377189
• Demi L, Wolfram F, Klersy C, De Silvestri A, Ferretti VV, Muller M, Miller D, Feletti F, Welnicki M, Buda N, Skoczylas A, Pomiecko A, Damjanovic D, Olszewski R, Kirkpatrick AW, Breitkreutz R, Mathis G, Soldati G, Smargiassi A, Inchingolo R, Perrone T. New International Guidelines and Consensus on the Use of Lung Ultrasound. J Ultrasound Med. 2023 Feb;42(2):309-344. doi: 10.1002/jum.16088. Epub 202 PMID 35993596
• Mento F, Khan U, Faita F, Smargiassi A, Inchingolo R, Perrone T, Demi L. State of the Art in Lung Ultrasound, Shifting from Qualitative to Quantitative Analyses. Ultrasound Med Biol. 2022 Dec;48(12):2398-2416. doi: 10.1016/j.ultrasmedbio.2022.07.007. Epub 2022 Sep 23. PMID 36155147
• Mento F, Demi L. Dependence of lung ultrasound vertical artifacts on frequency, bandwidth, focus and angle of incidence: An in vitro study. J Acoust Soc Am. 2021 Dec;150(6):4075. doi: 10.1121/10.0007482. PMID 34972265
• Guidi F, Demi L, Tortoli P. Experimental and simulation study of harmonic components generated by plane and focused waves. Ultrasonics. 2021 Sep;116:106504. doi: 10.1016/j.ultras.2021.106504. Epub 2021 Jun 22. PMID 34216989
• Peschiera E, Mento F, Demi L. Numerical study on lung ultrasound B-line formation as a function of imaging frequency and alveolar geometries. J Acoust Soc Am. 2021 Apr;149(4):2304. doi: 10.1121/10.0003930. PMID 33940883
• Mento F, Demi L. On the influence of imaging parameters on lung ultrasound B-line artifacts, in vitro study. J Acoust Soc Am. 2020 Aug;148(2):975. doi: 10.1121/10.0001797. PMID 32873037

Идентификаторы

NCT: NCT06533371 · 6855 · PNRR-MCNT2-2023-12378311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗