Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 3:38 PM
Study NCT ID:
NCT04487769
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Liberation from invasive ventilation', 'timeFrame': '28 days', 'description': 'Patient who survived but remained invasively ventilated up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Patient who survived up to day 28 were marked without event. Patients who survived but were extubated were marked with an event at the day of successful extubation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['new coronavirus disease', 'coronavirus disease 2019', 'lung imaging', 'lung ultrasound', 'lung ultrasound score', 'prognostication', 'duration of ventilation', 'mortality'], 'conditions': ['Covid19', 'Ultrasound', 'ARDS']}, 'referencesModule': {'references': [{'pmid': '34662857', 'type': 'DERIVED', 'citation': 'Pierrakos C, Lieveld A, Pisani L, Smit MR, Heldeweg M, Hagens LA, Smit J, Haaksma M, Veldhuis L, Schmidt RW, Errico G, Marinelli V, Attou R, David CE, Zimatore C, Murgolo F, Grasso S, Mirabella L, Cinnella G, De Bels D, Schultz MJ, Tuinman PR, Bos LD. A Lower Global Lung Ultrasound Score Is Associated with Higher Likelihood of Successful Extubation in Invasively Ventilated COVID-19 Patients. Am J Trop Med Hyg. 2021 Oct 18;105(6):1490-1497. doi: 10.4269/ajtmh.21-0545.'}]}, 'descriptionModule': {'briefSummary': 'To assess the prognostic performance of an early global LUS score with respect to the mortality in ICU and duration of ventilation.', 'detailedDescription': 'This is an international multicenter cohort study on data collected between March and April 2020. The first available lung ultrasound examination that used a 12-regions approach was used to calculate the global LUS score.\n\nPatients are included if they fulfilled the following criteria: 1) admitted to one of the participating ICU; 2) for invasive ventilation; 3) for respiratory failure due to confirmed COVID-19; and 4) having had a LUS examination performed within the first week of start of invasive ventilation.\n\nThe primary and secondary outcomes were liberation from invasive ventilation and mortality.\n\nDemographic, clinical and outcome variables will be presented as percentages for categorical variables and as medians with interquartile ranges (IQR) for continuous variables.\n\nReceiver operating characteristics (ROC) analysis will be used to derive the prognostic discriminatory performance of global LUS score in determining succesful extubation and mortality at day 28. The Youden index will be used to derive the optimal cut-off. The association of global LUS with unfavourable outcomes are analyzed with Cox proportional hazard analysis (for successful extubation and alive at day 28), logistic regression models (mortality at day 28). Hazard ratio or odds ratio with 95% confidence intervals were calculated for each outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe COVID-19 infection under invasive ventilation who received lung ultrasound examination as a standard care.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to an ICU participating in this study between February 1, 2020 and April 30, 2020\n* Confirmed with reverse transcriptase polymerase chain reaction (RT-PCR) COVID-19 infection\n* Having had received invasive ventilation\n* Having had examined at least once with lung ultrasound under invasive ventilation\n\nExclusion Criteria:\n\n* Age \\<18 years\n* First examination with LUS in patients already under extracorporeal membrane oxygenation (ECMO) support.'}, 'identificationModule': {'nctId': 'NCT04487769', 'acronym': 'LUS-COVID', 'briefTitle': 'Lung Ultrasound in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Early Lung Ultrasound Score Predicts Duration of Ventilation and ICU Mortality in COVID-19 Invasively Ventilated Patients', 'orgStudyIdInfo': {'id': 'LUS-COVID'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Marcus J Schultz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Amsterdam University Medical Centers, location 'AMC'"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Brussels, Brussels, Belgium', 'class': 'UNKNOWN'}, {'name': 'Miulli Regional Hospital, Acquaviva delle Fonti, Italy', 'class': 'UNKNOWN'}, {'name': 'University of Foggia', 'class': 'OTHER'}, {'name': 'University of Bari Aldo Moro', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. M.J. Schultz, MD, PhD', 'investigatorFullName': 'Prof. Dr. Marcus J. Schultz', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}