Using ultrasound to evaluate lung diseases
Synergistic Assessment of Ultrasound Data and Respiratory physiOlogical Signals in luNg Diseases
This study is testing whether lung ultrasound can help doctors better understand and monitor lung diseases like interstitial lung disease and COPD in both hospital patients and those visiting outpatient clinics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rome) |
| Trial ID | NCT06068647 on ClinicalTrials.gov |
What this trial studies
This study explores the use of lung ultrasound to assess various lung conditions, including interstitial lung disease and chronic obstructive pulmonary disease (COPD). It aims to investigate the physical mechanisms behind ultrasound artifacts that can provide diagnostic information about the lung's state when it is still aerated. The study will involve both inpatients and outpatients, utilizing lung ultrasound alongside computed tomography scans and cardio-respiratory evaluations to gather comprehensive data. The goal is to enhance understanding of lung ultrasound's capabilities in detecting and monitoring lung pathologies.
Who should consider this trial
Good fit: Ideal candidates include inpatients with exacerbated interstitial lung diseases or infectious interstitial pneumonia, as well as outpatients with stable COPD or emphysema.
Not a fit: Patients with severe skin conditions or those who have a history of allergic reactions to adhesives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy and monitoring of lung diseases, leading to better patient outcomes.
How similar studies have performed: While lung ultrasound has been widely accepted for certain applications, the specific exploration of non-consolidated lung tissue using ultrasound artifacts is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Riccardo Inchingolo, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Riccardo Inchingolo, MD, PhD
- Email: riccardo.inchingolo@policlinicogemelli.it
- Phone: +390630156062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.