Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06068647

Ultrasound and Respiratory Physiological Signals in Lung Diseases

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-02

25

Participants Needed

1

Research Sites

157 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

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

Official 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 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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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

CONTACT

A

Andrea Smargiassi, MD, PhD

CONTACT

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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