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Simple, Safe, Same: Lung Ultrasound for COVID-19 (LUSCOVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322487
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborators:
Valle del Serchio General Hospital, Lucca, Italy
University of Trento, Trento, Italy
Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy
Bresciamed, Brescia, Italy
118 USL Nordovest Toscana, Lucca, Italy
General Hospital, Voghera, Italy
Lodi General Hospital, Lodi, Italy
Information provided by (Responsible Party):
Riccardo Inchingolo, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment
Coronavirus Epidemic Disease Pneumonia, Viral Diagnostic Test: Lung ultrasound

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected or known COVID-19 patients.
Criteria

Inclusion Criteria:

  • suspected COVID-19 patients,
  • known COVID-19 patients.

Exclusion Criteria:

  • confirmed disease different from COVID-19.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322487


Contacts
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Contact: Libertario Demi, PhD 00390461283942 libertario.demi@unitn.it
Contact: Gino Soldati, MD soldatigino@yahoo.it

Locations
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Italy
Bresciamed Recruiting
Brescia, Italy
Contact: Elena Torri, MD       elena.torri@gmail.com   
Principal Investigator: Elena Torri, MD         
Pulmonary Medicine Unit, Lodi General Hospital Not yet recruiting
Lodi, Italy
Contact: Francesco Tursi, MD       francesco.tursi@asst-lodi.it   
Principal Investigator: Francesco Tursi, MD         
118 USL Nordovest Toscana Recruiting
Lucca, Italy
Contact: Alberto Mariani, MD       albertomariani4@virgilio.it   
Principal Investigator: Alberto Mariani, MD         
Diagnostic and Interventional Ultrasound Unit, Valle del Serchio General Hospital Active, not recruiting
Lucca, Italy
Emergency Department, Fondazione IRCCS Policlinico San Matteo, and Department of Internal Medicine and Therapeutics, University of Pavia Recruiting
Pavia, Italy
Contact: Tiziano Perrone, MD       tiziano.perrone76@gmail.com   
Principal Investigator: Tiziano Perrone, MD         
Principal Investigator: Domenica Federica Briganti, MD         
Principal Investigator: Stefano Perlini, MD         
Department of woman and child health and public health, Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, Italy, 00168
Contact: Danilo Buonsenso, MD       danilobuonsenso@gmail.com   
Principal Investigator: Danilo Buonsenso, MD         
Pulmonary Medicine Unit, Dept. Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, Italy, 00168
Contact: Riccardo Inchingolo, MD, PhD       riccardo.inchingolo@policlinicogemelli.it   
Contact: Andrea Smargiassi, MD, PhD       andrea.smargiassi@policlinicogemelli.it   
Principal Investigator: Riccardo Inchingolo, MD, PhD         
Principal Investigator: Andrea Smargiassi, MD, PhD         
Department of Information Engineering and Computer Science, Ultrasound Laboratory Trento, University of Trento Active, not recruiting
Trento, Italy
Emergency Medicine Unit, General Hospital Not yet recruiting
Voghera, Italy
Contact: Elisa Eleonora Mossolani, MD       elisa_mossolani@asst-pavia.it   
Principal Investigator: Elisa Eleonora Mossolani, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Valle del Serchio General Hospital, Lucca, Italy
University of Trento, Trento, Italy
Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy
Bresciamed, Brescia, Italy
118 USL Nordovest Toscana, Lucca, Italy
General Hospital, Voghera, Italy
Lodi General Hospital, Lodi, Italy
Investigators
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Principal Investigator: Riccardo Inchingolo, MD, PhD Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy
Principal Investigator: Andrea Smargiassi, MD, PhD Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italy
Principal Investigator: Libertario Demi, PhD Dept. of Information Engineering and Computer Science, University of Trento, Italy
Study Director: Gino Soldati, MD Diagnostic and Interventional Ultrasound Unit, Valle del Serchio Hospital, Lucca, Italy
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Responsible Party: Riccardo Inchingolo, Principal Investigator, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT04322487    
Other Study ID Numbers: 0013226/20
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Inchingolo, Catholic University of the Sacred Heart:
COVID-19
Lung ultrasound
Score
Acquisition protocol
International standardization
SARS-CoV-2
Pneumonia, viral
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases