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Ultrasound and Respiratory Physiological Signals in Lung Diseases (SAURON)

Primary Purpose

Interstitial Lung Disease, Interstitial Lung Diseases, Interstitial Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring Ultrasound, Ultrasound Imaging, Ultrasonography, Emphysema, Chronic obstructive pulmonary disease, Interstitial pneumonia, Interstitial lung disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
Evidence of paraseptal and/or panlobular emphysema.
Computed tomographic evidence of paraseptal and/or panlobular emphysema.
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
September 28, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Onera BV
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1. Study Identification

Unique Protocol Identification Number
NCT06068647
Brief Title
Ultrasound and Respiratory Physiological Signals in Lung Diseases
Acronym
SAURON
Official Title
Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Onera BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In the last years, lung ultrasonography has gained ever-growing clinical interest and curiosity because of its peculiar ability to acquire clinical information at bedside, its non-invasiveness and low cost. In particular settings (emergency medicine, intensive care unit) its utility has been well demonstrated. Clinicians use chest ultrasound for detecting pleural diseases, consolidations, bronchiolitis, interstitial lung pathology and critical pulmonary conditions of adults, children, and infants. However, the development of lung ultrasonography for exploring non-consolidated organs, has been not supported by a strong knowledge of the physical mechanisms that underlie pulmonary artifacts. Lung ultrasonography is comparable to a standard morphological sonography only when assessing a pulmonary consolidation, a tissue without air, which is in direct contact with the visceral pleural. In this case, the clinicians evaluate anatomic images, representing the real structure of the diseased organ. Differently, when the lung surface is denser but not yet consolidated, the large acoustic impedance gradient between the chest wall and the pulmonary tissue containing air prevents every anatomic representation, and the scan results in the visualization of many kinds of vertical artifacts known as B-Lines. Even though the practical role of lung ultrasound artifacts is accepted for detecting and monitoring many conditions, many of the published studies are empirical and further research is needed to clarify the physical genesis of vertical artifacts. These artifacts are diagnostic signs, but we do not fully understand their origin. The artifactual information beyond the pleura line in ultrasonographic 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. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma. The study intends to explore the relationship among ultrasound, tomographic and patch-based cardio-respiratory data, obtained from a heterogeneous population of patients suffering from: 1) pre-consolidative pulmonary changes such as diffuse interstitial lung diseases during exacerbation, 2) infectious interstitial pneumonia and 3) chronic obstructive pulmonary disease during both stable phase and exacerbations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of lung parenchymal involvement evaluated by lung ultrasound.
Description
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).
Time Frame
At enrollment.
Title
Evidence of paraseptal and/or panlobular emphysema.
Description
Computed tomographic evidence of paraseptal and/or panlobular emphysema.
Time Frame
At enrollment.
Title
Evidence of computed tomographic features and patterns of interstitial lung diseases.
Description
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.
Time Frame
At enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Inchingolo, MD, PhD
Phone
+390630156062
Email
riccardo.inchingolo@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Smargiassi, MD, PhD
Phone
+390630156062
Email
andrea.smargiassi@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Inchingolo, MD, PhD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Smargiassi, MD, PhD
Organizational Affiliation
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Inchingolo, MD, PhD
Phone
+390630156062
Email
riccardo.inchingolo@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Andrea Smargiassi, MD, PhD
Phone
+390630156062
Email
andrea.smargiassi@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Riccardo Inchingolo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27503755
Citation
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.
Results Reference
background
PubMed Identifier
36155147
Citation
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.
Results Reference
background
PubMed Identifier
32746228
Citation
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.
Results Reference
background
PubMed Identifier
28986558
Citation
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.
Results Reference
background
PubMed Identifier
32872996
Citation
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.
Results Reference
background
PubMed Identifier
22579543
Citation
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.
Results Reference
background
PubMed Identifier
23937897
Citation
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.
Results Reference
background
PubMed Identifier
30616416
Citation
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.
Results Reference
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Ultrasound and Respiratory Physiological Signals in Lung Diseases

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