NCT06068647 Ultrasound and Respiratory Physiological Signals in Lung Diseases
| NCT ID | NCT06068647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Interstitial Lung Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2023-03-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Riccardo Inchingolo, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06068647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Interstitial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06068647 currently recruiting?
Yes, NCT06068647 is actively recruiting participants. Contact the research team at riccardo.inchingolo@policlinicogemelli.it for enrollment information.
Where is the NCT06068647 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06068647 clinical trial?
NCT06068647 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Riccardo Inchingolo, MD, PhD at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 25 participants.