Official Title
Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
Brief Summary

Growing evidences are showing the usefulness of lung ultrasound in patients with COVID-19. Sars-CoV-2 has now spread in almost every country in the world. In this study, the investigators share their experience and propose a standardized approach in order to optimize the use of lung ultrasound in covid-19 patients. The investigators focus on equipment, procedure, classification and data-sharing.

Detailed Description

COVID-19 global emergency need a global unified approach, speaking all researchers the same
language. For this reason, the investigators propose a standardization for the international
use of lung ultrasound (LUS) for the management of COVID-19 patients.

The LUS COVID-team is made by Italian experts in lung ultrasound currently involved in the
clinical management of COVID-19 patients in different Italian areas, including the heavily
involved cities of Northern Italy. Moreover, experts in ultrasound physics and image analysis
are part of the team.

The team developed a standardized approach regarding equipment and acquisition protocol.
Moreover, the team proposed a scoring system for severity classification. To this aim,
clinicians shared 20 cases of confirmed COVID-19 on an anonymized virtual database, for a
total of about 44000 frames up to date. All team members discussed their clinical cases
through online meetings. Images were reviewed by all team members, blinded to the clinical
background, and listed in classes of severity of lung involvement based on LUS images. At the
end of this process, a biomedical engineer expert in lung ultrasound collected the data and
suggested a lung ultrasound grading system for COVID-19 pneumonia. Again, the biomedical
engineer re-submitted the images grouped in different classes of severity to the study
members, blinded of clinical data, to review again the images and evaluated agreement
regarding the LUS scores. The score was defined only when all team members agreed.

Methods In the setting of COVID-19, wireless probe and tablets represent the most appropriate
ultrasound equipment. These devices can easily be wrapped in single use plastic covers
reducing the risk of contamination and making easy the sterilization procedures. Such devices
are much less expensive than usual ultrasound machines including the portable ones.

In case of unavailability of these devices, portable machines dedicated to the exclusive use
of COVID-19 patients can be used, although maximum care for sterilization is necessary. In
these cases, probe and keyboard covers are anyway suggested, and sterilization procedures
necessary following last recommendations.

Sharing their real world experience in performing LUS in COVID-19 patients, the investigators
propose two different ways of performing lung ultrasound with pocket devices aiming to reduce
the exposition of health workers to cases.

One operator uses the probe performing the ultrasound; the other one keeps the tablet and
freezes images/videos. The second operator can be either in the room being at safe distance
from the patient (about 2 meters), or even remain outside the door communicating by
phone-call with the operator one in order to optimize the quality of images. Potentially,
this last approach can reduce the operator-dependence of the ultrasound since the second
operator blindly selects the images, being unaware of the clinical conditions of the patient.
The two operators will follow an agreed, tested and standardized images acquisition protocol.

Acquisition protocol Fourteen areas (three posterior, two lateral and two anterior) should be
scanned per patient along the lines here indicated. Scans need to be intercostal, as to cover
the widest surface possible with one scan.

Standard sequence of evaluations is proposed using landmarks on chest anatomic lines.
Echographic scans can be identified with a progressive numbering starting from right
posterior basal regions. For patient able to maintain the sitting position:

1. Right basal on paravertebral line above the curtain sign

2. Right middle on paravertebral line at the inferior angle of shoulder blade

3. Right upper on paravertebral line at spine of shoulder blade

4. Left basal on paravertebral line above the curtain sign

5. Left middle on paravertebral line at the inferior angle of shoulder blade

6. Left upper on paravertebral line at spine of shoulder blade

7. Right basal on mid-axillary line below the internipple line

8. Right upper on mid axillary line above the internipple line

9. Left basal on mid-axillary line below the internipple line

10. Left upper on mid axillary line above the internipple line

11. Right basal on mid-clavicular line below the internipple line

12. Right upper on mid-clavicular line above the internipple line

13. Left basal on mid-clavicular line below the internipple line

14. Left upper on mid-clavicular line above the internipple line

In case of performance of LUS in critical care settings (such as patients on invasive
ventilation) and for patients that are not able to maintain sitting position, the posterior
areas might be difficult to be evaluated. In these cases, the operator should try to have a
partial view of the posterior basal areas, currently considered a "hot-area" for COVID-19,
and however, start echographic assessment from landmark number 7.

- Use Convex or Linear probes, according to the patient's body size

- Use single focal point modality (no multifocusing), setting the focal point on the
pleura line. Employing a single focal point, and setting it at the right location, has
the benefit to optimize the beam shape for sensing the lung surface. At focus, the beam
has the smallest width as is therefore set to best respond to the smallest details.

- Keep the mechanical index (MI) low (start from 0.7 and reduce it further if allowed by
the visual findings). High MIs, employed for a long observation time, may result in
damaging the lung.

- Avoid as much as possible saturation phenomena, control gain and diminish MI if needed
(see example of lung ultrasound images in the figures). Saturation phenomena occurs,
e.g., when the signal streght of the echo signals is too high for the receiving
electronics to be converted into electrical signals conserving a linear relation with
the pressure amplitude. This has the effect of distorting the signals, and produces
images where the dynamics of the actual signal is lost. The visual appearance of this
phenomenon is the presence of areas which are completely white. In this case it is
therefore not possible to appreciate local variations in the response to
insonifications.

- Avoid the use of cosmetic filters and specific imaging modalities such as Harmonic
Imaging, Contrast, Doppler, Compounding.

- Achieve the highest frame rate possible (e.g. no persistence, no multifocusing)

- Save the data in DICOM format. In case this is not possible, save the data directly as a
video format. Visual findings, especially when related to very small alterations, do not
appear on every frame. It is thus advantageous to acquire movies, where the lung surface
below the landmark can be monitored for few seconds during breathing.

Scoring procedures

- Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are
present. These artifacts are generally referred as A-lines. They are due to the
high-reflectivity of the normally aerated lung surface, and characterize the visual
representation of the multiple reflections happening between the ultrasound probe and
the lung surface itself.

- Score 1: The pleura line is indented. Below the indent, vertical areas of white are
visible. These are due to local alterations in the acoustical properties of the lung, as
for example the replacement of volumes previously occupied by air in favor of media
which are acoustically much more similar to the intercostal tissue (water, blood,
tissue). This phenomenon opens channels accessible to ultrasound, which can explain the
appearance of the vertical artifacts.

- Score 2: The pleura line is broken. Below the breaking point, small to large
consolidated areas (darker areas) appear with associated areas of white below the
consolidated area (white lung).

The darkening of the consolidated areas signals the loss of aeration and the transition of
these areas towards acoustic properties similar to soft tissue over the entire area
represented by the consolidation itself. Beyond the consolidations, the appearance of areas
of white lung signals the presence of areas not yet fully deaerated, where air inclusions are
still present but embedded in tissue like material. This highly scattering environment can
explain this peculiar pattern.

- Score 3: The scanned area shows dense and largely extended white lung with or without
larger consolidations.

At the end of the procedure, the clinician will write for each area the highest score
obtained (e.g quadrant 1, score 2; quadrant 10, score 1; and so on).

Completed
Coronavirus
Epidemic Disease
Pneumonia, Viral

Diagnostic Test: Lung ultrasound

A proposal of a standardized approach in order to optimize the use of lung ultrasound in COVID-19 patients. We focus on equipment, procedure, classification and data-sharing.

Eligibility Criteria

Inclusion Criteria:

- suspected COVID-19 patients,

- known COVID-19 patients.

Exclusion Criteria:

- confirmed disease different from COVID-19.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
Italy
Locations

Bresciamed
Brescia, Italy

Pulmonary Medicine Unit, Lodi General Hospital
Lodi, Italy

118 USL Nordovest Toscana
Lucca, Italy

Diagnostic and Interventional Ultrasound Unit, Valle del Serchio General Hospital
Lucca, Italy

Emergency Department, Fondazione IRCCS Policlinico San Matteo, and Department of Internal Medicine and Therapeutics, University of Pavia
Pavia, Italy

Department of woman and child health and public health, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy

Pulmonary Medicine Unit, Dept. Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy

Department of Information Engineering and Computer Science, Ultrasound Laboratory Trento, University of Trento
Trento, Italy

Emergency Medicine Unit, General Hospital
Voghera, Italy

Catholic University of the Sacred Heart
NCT Number
Keywords
Covid-19
Lung ultrasound
Score
Acquisition protocol
International standardization
SARS-CoV-2
Pneumonia, viral
MeSH Terms
COVID-19
Pneumonia
Pneumonia, Viral