Ultrasound and Respiratory Physiological Signals in Lung Diseases

NCT06068647 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Lung ultrasound, computed tomographic scan and patch-based cardio-respiratory evaluations

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.

Sponsors & Collaborators

  • Onera BV

    collaborator INDUSTRY
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Riccardo Inchingolo, MD, PhD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  • Andrea Smargiassi, MD, PhD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06068647 on ClinicalTrials.gov