Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-31 @ 9:18 PM
Study NCT ID:
NCT02304133
Status:
COMPLETED
Last Update Posted:
2014-12-01
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfer From a Point-of-care Ultrasound Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2014-11-24', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound performance', 'timeFrame': '4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances', 'description': 'An Objective Structured Assessment of Ultrasound Skills (OSAUS) scoring form was used to assess ultrasound performance'}, {'measure': 'Diagnostic accuracy', 'timeFrame': '4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances', 'description': 'The ultrasound diagnoses were evaluated as "correct," "inconclusive," or "false," and the diagnostic accuracy was calculated by sensitivity and specificity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '26323998', 'type': 'DERIVED', 'citation': 'Todsen T, Jensen ML, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Ringsted C. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial. Am J Surg. 2016 Jan;211(1):40-5. doi: 10.1016/j.amjsurg.2015.05.025. Epub 2015 Jul 31.'}]}, 'descriptionModule': {'briefSummary': "This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.", 'detailedDescription': 'A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical Doctor\n* Signed up for a courses in abdominal point-of-care ultrasound\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02304133', 'briefTitle': 'Transfer From a Point-of-care Ultrasound Course', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Transfer From a Point-of-care Ultrasound Course to Diagnostic Performance on Patients - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-3-2012-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'participating in a four-hour course in abdominal POC US', 'interventionNames': ['Other: Education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'no training', 'interventionNames': ['Other: Education']}], 'interventions': [{'name': 'Education', 'type': 'OTHER', 'armGroupLabels': ['Control', 'Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tobias Todsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}