Ultrasound and Respiratory Physiological Signals in Lung Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

    Diagnostic test

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Thoracic ultrasonographic, tomographic and patch-based cardio-respiratory evaluationsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evidence of lung parenchymal involvement evaluated by lung ultrasound.

Ultrasonographic findings will be characterized according to internationally recognized and standardized score (LUS COVID protocol, doi:10.1002/jum.15285). Scoring procedures include: score 0 (the pleural line is continuous and regular; horizontal artifacts are present); score 1 (the pleural line is indented. Below the indent, vertical areas of white are visible); score 2 (the pleural line is broken. Below the breaking point, small-to-large, consolidated areas appear with associated areas of white below the consolidated area; score 3 (dense and extended white lung with or without larger consolidations).

Time frame
At enrollment.
2

Evidence of paraseptal and/or panlobular emphysema.

Computed tomographic evidence of paraseptal and/or panlobular emphysema.

Time frame
At enrollment.
3

Evidence of computed tomographic features and patterns of interstitial lung diseases.

Evidence of following features: 1) the presence or absence of pulmonary fibrosis 2) HRCT patterns of reticulation, honeycombing, ground glass and emphysema, as defined in the Fleischner society glossary of thoracic imaging (doi: 10.1148/radiol.2462070712) and 3) severity of traction bronchiectasis.

Time frame
At enrollment.

Secondary outcomes

Other outcomes

Sponsors and contacts

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