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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04322487|
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : March 8, 2022
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|Condition or disease||Intervention/treatment|
|Coronavirus Epidemic Disease Pneumonia, Viral||Diagnostic Test: Lung ultrasound|
|Study Type :||Observational|
|Actual Enrollment :||220 participants|
|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|
|Actual Primary Completion Date :||December 31, 2021|
|Actual Study Completion Date :||December 31, 2021|
- 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.
- Lung ultrasound grading system for COVID-19 pneumonia [ Time Frame: At enrollment. ]
- 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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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- suspected COVID-19 patients,
- known COVID-19 patients.
- confirmed disease different from COVID-19.
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
|Pulmonary Medicine Unit, Lodi General Hospital|
|118 USL Nordovest Toscana|
|Diagnostic and Interventional Ultrasound Unit, Valle del Serchio General Hospital|
|Emergency Department, Fondazione IRCCS Policlinico San Matteo, and Department of Internal Medicine and Therapeutics, University of Pavia|
|Department of woman and child health and public health, Fondazione Policlinico Universitario A. Gemelli IRCCS|
|Roma, Italy, 00168|
|Pulmonary Medicine Unit, Dept. Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS|
|Roma, Italy, 00168|
|Department of Information Engineering and Computer Science, Ultrasound Laboratory Trento, University of Trento|
|Emergency Medicine Unit, General Hospital|
|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|
|Responsible Party:||Riccardo Inchingolo, Principal Investigator, Catholic University of the Sacred Heart|
|Other Study ID Numbers:||
|First Posted:||March 26, 2020 Key Record Dates|
|Last Update Posted:||March 8, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases