Interstitial Lung DiseaseSAURONNCT06068647
Ultrasound and Respiratory Physiological Signals in Lung Diseases
A study testing Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations in people with Interstitial Lung Disease and Interstitial Lung Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Interstitial Lung Diseases, Interstitial Pneumonia
- What is being tested?
- Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Use of external cardiac defibrillators.
- Use of diaphragmatic pacers.
- Use of extra cardiac stimulators.
- Pregnancy.
- Pediatric population.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Riccardo Inchingolo, MD, PhD, +390630156062, riccardo.inchingolo@policlinicogemelli.it
Andrea Smargiassi, MD, PhD, +390630156062, andrea.smargiassi@policlinicogemelli.it
About this study
Official title: Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases
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.
Read more
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.
Read the 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.
- Conditions
- Interstitial Lung Disease, Interstitial Lung Diseases, Interstitial Pneumonia, Chronic Obstructive Pulmonary Disease, Emphysema or COPD, Ultrasonography
- Being tested
- Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations
- Keywords
- Ultrasound, Ultrasound Imaging, Ultrasonography, Emphysema, Chronic obstructive pulmonary disease, Interstitial pneumonia, Interstitial lung disease
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluationsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At enrollment.
Evidence of paraseptal and/or panlobular emphysema.
Computed tomographic evidence of paraseptal and/or panlobular emphysema.
Measured: 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.
Measured: At enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start22 Mar 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Onera BV
- Responsible party
- Sponsor
- Investigators
- Riccardo Inchingolo, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSAndrea Smargiassi, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068647
- Sponsor's protocol ID
- ID4710
- Acronym
- SAURON
- Status last verified
- May 2026
- First submitted
- 5 Jun 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27503755Mento 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.
PubMed 36155147Mento 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.
PubMed 32746228Demi 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.
PubMed 28986558Demi 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.
PubMed 32872996Soldati 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.
PubMed 22579543Smargiassi 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.
PubMed 23937897Soldati 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.
PubMed 30616416
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases
- ClinicalTrials.gov ID
- NCT06068647
- Acronym / sponsor ID
- SAURON / ID4710
- Conditions
- Interstitial Lung Disease, Interstitial Lung Diseases, Interstitial Pneumonia, Chronic Obstructive Pulmonary Disease, Emphysema or COPD, Ultrasonography
- Keywords
- Ultrasound, Ultrasound Imaging, Ultrasonography, Emphysema, Chronic obstructive pulmonary disease, Interstitial pneumonia, Interstitial lung disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Onera BV
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluations | Experimental | Diagnostic Test: Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluationsUltrasonographic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluationsUltrasonographic 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. | Diagnostic test | Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluations |
Primary outcome
Evidence of lung parenchymal involvement evaluated by lung ultrasound.
Time frame: At enrollment.
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.
Time frame: At enrollment.
Computed tomographic evidence of paraseptal and/or panlobular emphysema.
Evidence of computed tomographic features and patterns of interstitial lung diseases.
Time frame: At enrollment.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 27503755Soldati 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.
- Background: PubMed 36155147Mento 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.
- Background: PubMed 32746228Mento 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.
- Background: PubMed 28986558Demi 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.
- Background: PubMed 32872996Demi 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.
- Background: PubMed 22579543Soldati 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.
- Background: PubMed 23937897Smargiassi 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.
- Background: PubMed 30616416Soldati 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riccardo Inchingolo, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Andrea Smargiassi, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations in people with Interstitial Lung Disease and Interstitial Lung Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Inchingolo, MD, PhD (+390630156062, riccardo.inchingolo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of lung parenchymal involvement evaluated by lung ultrasound. (time frame: At enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068647, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.