Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06068647

Synergistic Assessment of Ultrasound Data and Respiratory Physiological Signals in Lung Diseases

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-05-20

25

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

O

Onera BV

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates the use of lung ultrasound and respiratory physiological signals to better understand lung diseases such as interstitial lung diseases during exacerbations, infectious interstitial pneumonia, and chronic obstructive pulmonary disease (COPD) in various stages. The study focuses on exploring the physical origins and diagnostic value of ultrasound artifacts, especially vertical artifacts that arise from complex interactions of ultrasound waves with lung tissue, which are not yet fully understood. By examining these artifacts, researchers aim to improve knowledge about the superficial lung parenchyma's physiological and pathological changes. Participants will undergo thoracic ultrasonographic scans using clinical machines and research platforms, with metal skin markers placed to align ultrasound images with computed tomography (CT) scans for precise comparison. On the same day as enrollment, a wearable system with sensors applied to the upper chest will collect physiological data including electrocardiography (ECG), respiratory effort and flow, physical activity, body position, and sound pressure levels. This combined approach aims to correlate ultrasound data with tomographic and cardio-respiratory signals from a diverse patient group. During the study, researchers will evaluate lung involvement using ultrasound, assess emphysema types and interstitial lung disease features through CT scans, all at enrollment. Data collection includes ultrasound videos, CT images, and continuous physiological monitoring from the wearable sensors. The study involves both inpatients and outpatients with specific lung conditions and includes careful monitoring of skin reactions due to sensor application. The participation duration and follow-up details are based on the enrollment assessments and data collection periods.

CONDITIONS

Brief Title

Ultrasound and Respiratory Physiological Signals in Lung Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Inpatients admitted with diffuse interstitial lung diseases during exacerbation OR infectious interstitial pneumonia not caused by SARS-CoV-2 OR acute COPD exacerbation.
  • Outpatients with pulmonary paraseptal and/or panlobular emphysema and/or COPD during stable phase.
  • Able to provide written informed consent.
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo lung ultrasonography, computed tomographic scans, and patch-based cardio-respiratory evaluations to assess lung conditions and physiological signals.

1 enrollment visit (in-person)

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

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Research Team

R

Riccardo Inchingolo, MD, PhD

A

Andrea Smargiassi, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Quantitative Lung Ultrasound Spectroscopy Applied to the Diagnosis of Pulmonary Fibrosis: The First Clinical Study.

Federico Mento, Gino Soldati, Renato Prediletto...

https://pubmed.ncbi.nlm.nih.gov/32746228

Determination of a potential quantitative measure of the state of the lung using lung ultrasound spectroscopy.

Libertario Demi, Wim van Hoeve, Ruud J G van Sloun...

https://pubmed.ncbi.nlm.nih.gov/28986558