CoronavirusLUSCOVID19NCT04322487
Simple, Safe, Same: Lung Ultrasound for COVID-19
An observational study of Coronavirus and Epidemic Disease, run by Catholic University of the Sacred Heart at 9 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus, Epidemic Disease, Pneumonia, Viral
- What is being tested?
- Lung ultrasound
- How many people
- 220 participants
- Where
- 9 sitesItaly
- Study dates
- 8 Apr 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Suspected or known COVID-19 patients.
Who may be able to join
- suspected COVID-19 patients,
- known COVID-19 patients.
Who cannot join
- confirmed disease different from COVID-19.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Bresciamed
Brescia
Pulmonary Medicine Unit, Lodi General Hospital
Lodi
118 USL Nordovest Toscana
Lucca
Diagnostic and Interventional Ultrasound Unit, Valle del Serchio General Hospital
Lucca
Emergency Department, Fondazione IRCCS Policlinico San Matteo, and Department of Internal Medicine and Therapeutics, University of Pavia
Pavia
Department of woman and child health and public health, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Pulmonary Medicine Unit, Dept. Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Department of Information Engineering and Computer Science, Ultrasound Laboratory Trento, University of Trento
Trento
Emergency Medicine Unit, General Hospital
Voghera
About this study
Official title: Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
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.
Read the 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:
- Right basal on paravertebral line above the curtain sign
- Right middle on paravertebral line at the inferior angle of shoulder blade
- Right upper on paravertebral line at spine of shoulder blade
- Left basal on paravertebral line above the curtain sign
- Left middle on paravertebral line at the inferior angle of shoulder blade
- Left upper on paravertebral line at spine of shoulder blade
- Right basal on mid-axillary line below the internipple line
- Right upper on mid axillary line above the internipple line
- Left basal on mid-axillary line below the internipple line
- Left upper on mid axillary line above the internipple line
- Right basal on mid-clavicular line below the internipple line
- Right upper on mid-clavicular line above the internipple line
- Left basal on mid-clavicular line below the internipple line
- 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).
- Conditions
- Coronavirus, Epidemic Disease, Pneumonia, Viral
- Being tested
- Lung ultrasound
- Keywords
- COVID-19, Lung ultrasound, Score, Acquisition protocol, International standardization, SARS-CoV-2, Pneumonia, viral
- Medical subject headings
- Coronavirus Infections, Pneumonia, Viral, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start8 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Valle del Serchio General Hospital, Lucca, Italy, Università degli Studi di Trento, Fondazione IRCCS Policlinico San Matteo di Pavia, Bresciamed, Brescia, Italy, 118 USL Nordovest Toscana, Lucca, Italy, General Hospital, Voghera, Italy, Lodi General Hospital, Lodi, Italy
- Responsible party
- Principal investigator, Riccardo Inchingolo, Catholic University of the Sacred Heart
- Investigators
- Riccardo Inchingolo, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, ItalyAndrea Smargiassi, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, ItalyLibertario Demi, PhD, Principal investigator, Dept. of Information Engineering and Computer Science, University of Trento, ItalyGino Soldati, MD, Study director, Diagnostic and Interventional Ultrasound Unit, Valle del Serchio Hospital, Lucca, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322487
- Sponsor's protocol ID
- 0013226/20
- Acronym
- LUSCOVID19
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
- ClinicalTrials.gov ID
- NCT04322487
- Acronym / sponsor ID
- LUSCOVID19 / 0013226/20
- Conditions
- Coronavirus, Epidemic Disease, Pneumonia, Viral
- Keywords
- COVID-19, Lung ultrasound, Score, Acquisition protocol, International standardization, SARS-CoV-2, Pneumonia, viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Valle del Serchio General Hospital, Lucca, Italy, Università degli Studi di Trento, Fondazione IRCCS Policlinico San Matteo di Pavia, Bresciamed, Brescia, Italy, 118 USL Nordovest Toscana, Lucca, Italy, General Hospital, Voghera, Italy, Lodi General Hospital, Lodi, Italy
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Right basal on paravertebral line above the curtain sign
- Right middle on paravertebral line at the inferior angle of shoulder blade
- Right upper on paravertebral line at spine of shoulder blade
- Left basal on paravertebral line above the curtain sign
- Left middle on paravertebral line at the inferior angle of shoulder blade
- Left upper on paravertebral line at spine of shoulder blade
- Right basal on mid-axillary line below the internipple line
- Right upper on mid axillary line above the internipple line
- Left basal on mid-axillary line below the internipple line
- Left upper on mid axillary line above the internipple line
- Right basal on mid-clavicular line below the internipple line
- Right upper on mid-clavicular line above the internipple line
- Left basal on mid-clavicular line below the internipple line
- 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Suspected or known COVID-19 patients.
Key inclusion criteria (2 listed)
- suspected COVID-19 patients,
- known COVID-19 patients.
Key exclusion criteria (1 listed)
- confirmed disease different from COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundA 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. | Diagnostic test | – |
Primary outcome
Lung ultrasound grading system for COVID-19 pneumonia
Time frame: At enrollment.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Inchingolo, MD, PhD principal investigator
Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy
Andrea Smargiassi, MD, PhD principal investigator
Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy
Libertario Demi, PhD principal investigator
Dept. of Information Engineering and Computer Science, University of Trento, Italy
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and Epidemic Disease, run by Catholic University of the Sacred Heart at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound grading system for COVID-19 pneumonia (time frame: At enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022; AzTrials last refreshed its copy on 2 Nov 2026.