An observational study in Coronavirus, Epidemic Disease and Pneumonia, Viral, sponsored by Catholic University of the Sacred Heart. Completed at 9 sites in Italy. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Catholic University of the Sacred Heart · Observational
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.
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:
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.
Scoring procedures
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.
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 220 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
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Suspected or known COVID-19 patients.
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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.
Lung ultrasound grading system for COVID-19 pneumonia
Scoring procedures * Score 0: The pleura line is continuous, regular. Horizontal artifacts (A-line) are present. These artifacts are generally referred as A-lines. * Score 1: The pleura line is indented. Below the indent, vertical areas of white are visible. * 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). * 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.
Time frame: At enrollment.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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