Ultrasound and Respiratory Physiological Signals in Lung Diseases

NCT06068647 | Recruiting

• 1 other identifier: ID4710
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The use of lung ultrasound is instrumental in the evaluation of many chest pathologies and its ability to detect pleuro-pulmonary pathology is widely accepted. However, the use of ultrasound to explore the state of the peripheral lung parenchyma, when the organ is still aerated, is a relatively new application. Horizontal and vertical artifacts are separate and distinct artifacts that can be seen during ultrasound examination of the lungs. While the practical role of lung ultrasound artifacts is accepted to detect and monitor many conditions, further research is needed for the physical interpretation of ultrasound artifacts. These artifacts are diagnostic signs, but we don't fully understand their origin. The artifactual information deriving from the surface acoustic interaction, beyond the pleural line, in the ultrasound images of the normally aerated and non-deflated lung, represents the final result of complex interactions of acoustic waves with a specific three-dimensional structure of the biological tissue. Thus, the umbrella term "vertical artifacts" oversimplifies many physical phenomena associated with a pathological pleural plane. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma. Therefore, the need emerges to explore the physical phenomena underlying the artifactual ultrasound information deriving from the surface acoustic interaction of ultrasound with the pleuro-pulmonary structures.

Conditions

Interstitial Lung Disease; Interstitial Lung Diseases; Interstitial Pneumonia; Chronic Obstructive Pulmonary Disease; Emphysema or COPD; Ultrasonography; Ultrasound Imaging; Ultrasound

Keywords

Ultrasound; Ultrasound Imaging; Ultrasonography; Emphysema; Chronic obstructive pulmonary disease; Interstitial pneumonia; Interstitial lung disease

Outcome Measures

Primary Outcomes (3)

• Evidence of lung parenchymal involvement evaluated by lung ultrasound.

  Ultrasonographic findings will be characterized according to internationally recognized and standardized score (LUS COVID protocol, doi:10.1002/jum.15285). Scoring procedures include: score 0 (the pleural line is continuous and regular; horizontal artifacts are present); score 1 (the pleural line is indented. Below the indent, vertical areas of white are visible); score 2 (the pleural line is broken. Below the breaking point, small-to-large, consolidated areas appear with associated areas of white below the consolidated area; score 3 (dense and extended white lung with or without larger consolidations).

  At enrollment.

• Evidence of paraseptal and/or panlobular emphysema.

  Computed tomographic evidence of paraseptal and/or panlobular emphysema.

  At enrollment.

• Evidence of computed tomographic features and patterns of interstitial lung diseases.

  Evidence of following features: 1) the presence or absence of pulmonary fibrosis 2) HRCT patterns of reticulation, honeycombing, ground glass and emphysema, as defined in the Fleischner society glossary of thoracic imaging (doi: 10.1148/radiol.2462070712) and 3) severity of traction bronchiectasis.

  At enrollment.

Study Arms (1)

Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluations

EXPERIMENTAL

Ultrasonographic findings will be obtained with clinical machines. Additionally, ultrasonographic scans as acquired with research platform will also be gathered. Metal cutaneous landmarks will be positioned and left during computed tomography scans, indicating the areas of ultrasonographic assessment. This method will support a more accurate comparison between ultrasonographic patterns and CT scans peripheral lung findings. Finally, on the same day of enrolment, a wearable system for measuring physiological signals, will be applied. The sensors will be applied to the upper chest. The following information will be collected by each sensor: ECG, respiratory effort, respiratory flow, activity, position, and sound pressure level.

Diagnostic Test: Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations

Interventions

Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations DIAGNOSTIC_TEST

Ultrasonographic findings will be obtained with machines supplied with clinical Units. Additionally, US scans as acquired with open research platform will also be gathered. For both scanners, ultrasonographic scans will be performed and videos will be recorded and stored in each landmark. Metal cutaneous landmarks will be positioned and left during computed tomographic (CT) scans, indicating the areas of ultrasonographic assessment. Finally, on the same day of enrolment, a wearable system for measuring physiological signals, will be applied. Within the scope of this study, sensors will be applied to the upper chest. The following information will be collected by each sensor: electrocardiography, respiratory effort, respiratory flow, activity, position, and sound pressure level.

Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inpatients admitted to the hospital due to diffuse interstitial lung diseases during exacerbation OR infectious interstitial pneumonia not caused by SARS-CoV-2 OR acute exacerbation of chronic obstructive pulmonary disease.
• Outpatients with pulmonary paraseptal and/or panlobular emphysema and/or chronic obstructive pulmonary disease during stable phase.
• Patients able to give written informed consent.

You may not qualify if:

• history of skin irritation, redness, itching or allergic cutaneous symptoms.
• Allergic reactions to adhesives or hydrogels.
• Family history of adhesive skin allergies.
• Presence of severe skin conditions such as wounds, burns or on any damaged skin.
• Presence of strong magnetic fields in the study setting.
• Presence of electromagnetic disturbances or significant ionizing radiation sources which might lead to signal artifacts.
• Use of external cardiac defibrillators.
• Use of diaphragmatic pacers.
• Use of extra cardiac stimulators.
• Pregnancy.
• Pediatric population.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Onera BV: collaborator

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Related Publications (8)

• Soldati G, Demi M, Inchingolo R, Smargiassi A, Demi L. On the Physical Basis of Pulmonary Sonographic Interstitial Syndrome. J Ultrasound Med. 2016 Oct;35(10):2075-86. doi: 10.7863/ultra.15.08023. Epub 2016 Aug 8. No abstract available.

  PMID: 27503755 BACKGROUND

• 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 BACKGROUND

• Mento F, Soldati G, Prediletto R, Demi M, Demi L. Quantitative Lung Ultrasound Spectroscopy Applied to the Diagnosis of Pulmonary Fibrosis: The First Clinical Study. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Nov;67(11):2265-2273. doi: 10.1109/TUFFC.2020.3012289. Epub 2020 Jul 27.

  PMID: 32746228 BACKGROUND

• Demi L, van Hoeve W, van Sloun RJG, Soldati G, Demi M. Determination of a potential quantitative measure of the state of the lung using lung ultrasound spectroscopy. Sci Rep. 2017 Oct 6;7(1):12746. doi: 10.1038/s41598-017-13078-9.

  PMID: 28986558 BACKGROUND

• Demi L, Demi M, Prediletto R, Soldati G. Real-time multi-frequency ultrasound imaging for quantitative lung ultrasound - first clinical results. J Acoust Soc Am. 2020 Aug;148(2):998. doi: 10.1121/10.0001723.

  PMID: 32872996 BACKGROUND

• Soldati G, Inchingolo R, Smargiassi A, Sher S, Nenna R, Inchingolo CD, Valente S. Ex vivo lung sonography: morphologic-ultrasound relationship. Ultrasound Med Biol. 2012 Jul;38(7):1169-79. doi: 10.1016/j.ultrasmedbio.2012.03.001. Epub 2012 May 12.

  PMID: 22579543 BACKGROUND

• Smargiassi A, Inchingolo R, Soldati G, Copetti R, Marchetti G, Zanforlin A, Giannuzzi R, Testa A, Nardini S, Valente S. The role of chest ultrasonography in the management of respiratory diseases: document II. Multidiscip Respir Med. 2013 Aug 9;8(1):55. doi: 10.1186/2049-6958-8-55.

  PMID: 23937897 BACKGROUND

• Soldati G, Demi M, Smargiassi A, Inchingolo R, Demi L. The role of ultrasound lung artifacts in the diagnosis of respiratory diseases. Expert Rev Respir Med. 2019 Feb;13(2):163-172. doi: 10.1080/17476348.2019.1565997. Epub 2019 Jan 10.

  PMID: 30616416 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

• Riccardo Inchingolo, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

• Andrea Smargiassi, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Inchingolo, MD, PhD

CONTACT

+390630156062; riccardo.inchingolo@policlinicogemelli.it

Andrea Smargiassi, MD, PhD

CONTACT

+390630156062; andrea.smargiassi@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: October 5, 2023
• Study Start: March 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)