Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04393402
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2020-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LUS applicability with COVID 19', 'timeFrame': '10 months', 'description': 'In dorsal position, or in prone position, the two hemithorax will be subdivided in 6 parts, and a score will be attributed with the following criteria : A-Lines (0 point), \\> 3 B-lines (1 point), B-Lines coalscent (2 points), and pulmonary consolidation (3 points). For the echography we can use a convexe sonde, or a "cardiac" sonde.'}], 'secondaryOutcomes': [{'measure': 'Radiographic correlation (chest Xray and tomodensitometry)', 'timeFrame': '10 months', 'description': 'Comparison between Xray / CT scan exam and LUS'}, {'measure': 'LUS Mortality prediction', 'timeFrame': '10 months', 'description': 'according to LUS score, ventilatory mode and parameters, medical history and bood analysis results'}, {'measure': 'Prediction of Prone position response', 'timeFrame': '10 months', 'description': 'comparison of LUS score depending of the position used for performing LUS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'descriptionModule': {'briefSummary': 'It might be necessary with Sars-Cov2 pneumopathy patient to repeat thoracic images, the tomodensitometry ones in particular. This task is difficult and nearly impossible for several reasons: respiratory and hemodynamic unstable patient, prone position and due to the high contagious nature of the disease.\n\nThe lung ultrasound is an easy tool, fast (between 5 and 10 minutes) and as a limited training.\n\nIn the context of the Sars-Cov2 epidemic, Buonsenso and al case report depict the first lung ultrasound for a Covid 19 patient.\n\nPeng and al in Intensive Care Medicine accentuate the usefulness of this particular technic.\n\nIn the American Journal of Respiratory and Critical Care Medicine, a study has been published as a point-of-care, in which the doctors reported using the lung ultrasound with intensive and critical care patient.\n\nIn Critical Care 2016, it has been showed that ultrasound allowed with neat precisions, to predict severe ARDS patient response to the prone position, all-cause.\n\nAnother researchers team found a good correlation between lung ultrasound, the SOFA, APACHE II, CPIS score, and patient mortality.\n\nAnd a new applicability in the pulmonary recruitment by PEEP titration has been presented.\n\nThe aim of this study is to evaluate the lung ultrasound in Covid19 ARDS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with diagnose of Covid 19 by usully method, and admitted in critical care unit for oxygen-therapy or ventilatory support.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Sars-Cov2 patient, with PCR method qualitative or quantitative as usual.\n* Intensive or critical care admission\n* ARDS with PaO2/FiO2 \\<300 at the admission\n* Ventilatory support or oxygen-therapy\n\nExclusion Criteria:\n\n* Age \\< 18 years-old\n* Pregnancy\n* Patient with tutor- or curatorship or in prison'}, 'identificationModule': {'nctId': 'NCT04393402', 'acronym': 'LUS-COVID19', 'briefTitle': 'Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care (LUS-COVID19)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Lung Ultrasound Score in Covid 19 Infectious Disease in Critical Care', 'orgStudyIdInfo': {'id': '20reamedcovid03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Covid-19 and admitted in critical care unit', 'interventionNames': ['Procedure: lung ultrasound (LUS)']}], 'interventions': [{'name': 'lung ultrasound (LUS)', 'type': 'PROCEDURE', 'description': 'Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS', 'armGroupLabels': ['Patients with Covid-19 and admitted in critical care unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No data sharing plan has been established'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}