Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06219005
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2024-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Nerve Block Training Model and Evaluation Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective observational cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician knowledge assessment', 'timeFrame': '4 months', 'description': 'The investigators will assess ultrasound-guided serratus anterior nerve block in a simulation model using surveys at 1 month pre-intervention, post-intervention, and 3 months post-intervention (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree)'}, {'measure': 'Physician technical skills assessment', 'timeFrame': '4 months', 'description': 'The investigators will assess ultrasound-guided serratus anterior nerve block in a simulation model using surveys at 1 month pre-intervention, post-intervention, and 3 months post-intervention (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).'}], 'secondaryOutcomes': [{'measure': 'acceptability of our implementation strategy', 'timeFrame': '4 months', 'description': 'The investigators will evaluate EM physician education and simulation workshop implementation strategy acceptability using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).'}, {'measure': 'appropriateness of our implementation strategy', 'timeFrame': '4 months', 'description': 'The investigators will evaluate EM physician education and simulation workshop implementation strategy appropriateness using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).'}, {'measure': 'feasibility of our implementation strategy', 'timeFrame': '4 months', 'description': 'The investigators will evaluate EM physician education and simulation workshop implementation strategy feasibility using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Blocks', 'Medical Education, Simulation, Crisis Resource Management', 'Medical Education in Emergency Ultrasound']}, 'referencesModule': {'references': [{'pmid': '23777999', 'type': 'BACKGROUND', 'citation': 'Petrosoniak A, Herold J, Woolfrey K. Emergency medicine procedural skills: what are residents missing? CJEM. 2013 Jul;15(4):241-8. doi: 10.2310/8000.2013.130897.'}, {'pmid': '18652729', 'type': 'BACKGROUND', 'citation': 'Sherbino J, Bandiera G, Frank JR. Assessing competence in emergency medicine trainees: an overview of effective methodologies. CJEM. 2008 Jul;10(4):365-71. doi: 10.1017/s1481803500010381.'}], 'seeAlsoLinks': [{'url': 'https://www.acep.org/patient-care/policy-statements/ultrasound-guidelines-emergency-point-of--care-and-clinical-ultrasound-guidelines-in-medicine', 'label': 'ACEP emergency ultrasound guidelines'}, {'url': 'https://www.ifem.cc/point_of_care_ultrasound_curriculum_guidelines', 'label': 'IFEM point-of-care-ultrasound guidelines'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess emergency medicine physician knowledge and technical skill in performance of ultrasound-guided serratus anterior nerve block in a low-fidelity simulation model workshop and to determine the feasibility, acceptability, and usability of the training program. By performing this study, the investigators hope to create a standardized training model which could potentially facilitate POCUS and critical procedural performance and thereby improve patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency medicine attending and resident physicians\n\nExclusion Criteria:\n\n* ED nursing, ED technicians, and advanced practice physicians (APPs)'}, 'identificationModule': {'nctId': 'NCT06219005', 'briefTitle': 'Ultrasound-guided Nerve Block Training Model and Evaluation Method', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Standardized Assessment of Emergency Physician Ultrasound-guided Nerve Block Training Using a Low-fidelity Simulation Model', 'orgStudyIdInfo': {'id': 'Pro00114989'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emergency Medicine attending physicians and residents', 'interventionNames': ['Behavioral: ultrasound education and simulation workshop']}], 'interventions': [{'name': 'ultrasound education and simulation workshop', 'type': 'BEHAVIORAL', 'description': 'workshop testing emergency physician knowledge and technical skills in performing ultrasound-guided nerve blocks in a simulation model', 'armGroupLabels': ['Emergency Medicine attending physicians and residents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All participant information will be confidential and restricted to the research study team. Deidentified summary data will be made available after study completion for public and scientific community dissemination and future clinical improvements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}