Coronavirus Clinical Trial
— LUSCOVID19Official title:
Proposal for International Standardization of the Use of Lung Ultrasound for COVID-19 Patients; a Simple, Quantitative, Reproducible Method
NCT number | NCT04322487 |
Other study ID # | 0013226/20 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 8, 2020 |
Est. completion date | December 31, 2021 |
Verified date | March 2022 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 220 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - suspected COVID-19 patients, - known COVID-19 patients. Exclusion Criteria: - confirmed disease different from COVID-19. |
Country | Name | City | State |
---|---|---|---|
Italy | 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 |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | 118 USL Nordovest Toscana, Lucca, Italy, Bresciamed, Brescia, Italy, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy, General Hospital, Voghera, Italy, Lodi General Hospital, Lodi, Italy, Università degli Studi di Trento, Valle del Serchio General Hospital, Lucca, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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