Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-29 @ 2:47 AM
Study NCT ID:
NCT04719234
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2021-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasonography in COVID-19 Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-21', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the relation of the lesions with the pleura', 'timeFrame': '6 hours', 'description': 'the relation of the lesions with the pleura, and their distance to the pleura.'}], 'primaryOutcomes': [{'measure': 'Relationship between Thoracic CT imaging results and LUS results', 'timeFrame': '6 hours', 'description': 'Lung ultrasonography will be performed within 6 hours of the Thoracic CT.'}], 'secondaryOutcomes': [{'measure': 'Characteristics of lesions', 'timeFrame': '6 hours', 'description': 'İdentifying the characteristics of the abnormal findings detected in Thoracic CT and LUS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Ultrasound', 'Pneumonia', 'Covid19']}, 'referencesModule': {'references': [{'pmid': '33638057', 'type': 'DERIVED', 'citation': 'Okmen K, Yildiz DK, Soyaslan E. Comparison of lung ultrasonography findings with chest computed tomography results in coronavirus (COVID-19) pneumonia. J Med Ultrason (2001). 2021 Apr;48(2):245-252. doi: 10.1007/s10396-021-01081-7. Epub 2021 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'Lung ultrasonography has been used for diagnosis and treatment in many departments including intensive care before the pandemic. The gold standard method for the diagnosis of pneumonia is still chest tomography. Ultrasonography, which has advantages over tomography, has also been tried to be used in covid 19 pneumonia.', 'detailedDescription': 'In this study, it was aimed to investigate the efficiency of lung ultrasonography in diagnosis of covid 19 pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and 85 years old\n* Hospitalized in intensive care unit\n* PCR tested\n* Thoracic CT applied\n\nExclusion Criteria:\n\n* Previous lung and thoracic wall surgery\n* Anatomically with thoracic wall disorder\n* Patients who did not consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04719234', 'briefTitle': 'Lung Ultrasonography in COVID-19 Pneumonia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Comparison of Lung Ultrasonography Findings With Chest Computerized Tomography Results in Corona virüs (COVID-19) Pneumonia', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2020/5-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'lung ultrasound', 'description': 'lung ultrasonography protocol will be applied.', 'interventionNames': ['Device: lung ultrasonography']}], 'interventions': [{'name': 'lung ultrasonography', 'type': 'DEVICE', 'description': 'Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)', 'armGroupLabels': ['lung ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Korgün Ökmen, Assoc. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi'}, {'name': 'Durdu Kahraman Yıldız, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi'}, {'name': 'Emel Tatar Soyaslan, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator ,Assoc. PhD. M.D.', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}