Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04412551
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-01', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of requirement of mechanical ventilation', 'timeFrame': '3 weeks', 'description': 'Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU'}], 'secondaryOutcomes': [{'measure': 'Prediction of requirement of mechanical ventilation', 'timeFrame': '3 weeks', 'description': 'Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU'}, {'measure': 'Association of LUS to clinical parameters', 'timeFrame': '3 weeks', 'description': 'Descriptive assessment of clinical parameters and LUS-score over time'}, {'measure': 'Description of findings on LUS', 'timeFrame': '3 weeks', 'description': 'Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasonography', 'lung ultrasound', 'covid-19', 'ARDS'], 'conditions': ['Corona Virus Infection', 'Virus Diseases', 'Coronaviridae Infections']}, 'referencesModule': {'references': [{'pmid': '25501898', 'type': 'BACKGROUND', 'citation': 'Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.', 'detailedDescription': 'Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference.\n\nApart from assessment with LUS, patients are managed according to routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Covid-19 confirmed by positive polymerase chain reaction (PCR)\n* oxygen by mask or nasal prongs ≥ 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) ≥ 30%\n* age between 18-80 years\n* informed consent\n\nExclusion Criteria:\n\n* patients subject to treatment-limitation "no ICU"\n* history of heart failure\n* history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis\n* history of kidney failure requiring dialysis\n* any reason making lung ultrasound or daily follow up impossible\n* opposition to participation in the study'}, 'identificationModule': {'nctId': 'NCT04412551', 'briefTitle': 'Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'Dalarna County Council, Sweden'}, 'officialTitle': 'Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19', 'orgStudyIdInfo': {'id': 'LUS-Covid001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Falun', 'country': 'Sweden', 'facility': 'Falun Hospital', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalarna County Council, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine', 'investigatorFullName': 'Maria Hårdstedt', 'investigatorAffiliation': 'Dalarna County Council, Sweden'}}}}