Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT02866318
Status:
UNKNOWN
Last Update Posted:
2016-08-15
First Post:
2016-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Learning curve', 'timeFrame': '2 hours', 'description': 'Rate of concordance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Echocardiography']}, 'descriptionModule': {'briefSummary': "This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.", 'detailedDescription': 'Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement.\n\nThis procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study.\n\nA participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM.\n\nAnd, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EM residents who have no experience of echocardiography\n\nExclusion Criteria:\n\n* They do not want to participate this study'}, 'identificationModule': {'nctId': 'NCT02866318', 'acronym': 'LCCUSUMLVEF', 'briefTitle': 'Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': "CUSUM Analysis in the Assessment of Novice Practitioners' Visual Estimation in LV Ejection Fraction With Echocardiographic Images", 'orgStudyIdInfo': {'id': 'LCCUSUMchallenge1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novice practitioners', 'description': 'Residents in Emergency department who has no experiences of echocardiography prior to the study.', 'interventionNames': ['Device: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DEVICE', 'armGroupLabels': ['Novice practitioners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471-701', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'YOONJE LEE, M.D.', 'role': 'CONTACT', 'email': 'yong0831@naver.com', 'phone': '+82-31-560-2053'}, {'name': 'YOONJE LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}], 'centralContacts': [{'name': 'YOONJE LEE, M.D.', 'role': 'CONTACT', 'email': 'yong0831@naver.com', 'phone': '+82-31_560-2053'}, {'name': 'CHANGSUN KIM, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'flyes98@naver.com', 'phone': '+82-31-560-2057'}], 'overallOfficials': [{'name': 'YOONJE LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship, Emergency Medincine', 'investigatorFullName': 'LEE YOON-JE', 'investigatorAffiliation': 'Hanyang University'}}}}