Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 8:45 PM
Study NCT ID:
NCT06950333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Applications for Emergency Medical Technicians in Taiwan
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-13', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound Image Quality Score for Target Structure Visualization', 'timeFrame': 'From enrollment to one day after patient was sent to hospital', 'description': "The score of ultrasound images assessing the visualization quality of target anatomical structures (e.g., blood vessels, Morrison's pouch, spleno-renal recess, cul-de-sac), evaluated using a standardized 10-point image quality rating scale (1 = Poor, 10 = Excellent). Each ultrasound image receives an overall score reflecting the adequacy of target structure visualization, as rated by trained reviewers."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehospital ultrasound', 'emergency medical technicians', 'Education'], 'conditions': ['Prehospital Emergency Medical Services', 'Point-of-care Ultrasound']}, 'referencesModule': {'references': [{'pmid': '21873854', 'type': 'BACKGROUND', 'citation': 'Nations JA, Browning RF. Battlefield applications for handheld ultrasound. Ultrasound Q. 2011 Sep;27(3):171-6. doi: 10.1097/RUQ.0b013e31822b7c14.'}, {'pmid': '22867834', 'type': 'BACKGROUND', 'citation': 'Brun PM, Chenaitia H, Gonzva J, Bessereau J, Bobbia X, Peyrol M; WINFOCUS (World Interactive Network Focused On Critical UltraSound) Group France. The value of prehospital echocardiography in shock management. Am J Emerg Med. 2013 Feb;31(2):442.e5-7. doi: 10.1016/j.ajem.2012.05.021. Epub 2012 Aug 4. No abstract available.'}, {'pmid': '30192687', 'type': 'BACKGROUND', 'citation': 'Fitzgibbon JB, Lovallo E, Escajeda J, Radomski MA, Martin-Gill C. Feasibility of Out-of-Hospital Cardiac Arrest Ultrasound by EMS Physicians. Prehosp Emerg Care. 2019 May-Jun;23(3):297-303. doi: 10.1080/10903127.2018.1518505. Epub 2018 Oct 17.'}, {'pmid': '32815755', 'type': 'BACKGROUND', 'citation': 'Mercer CB, Ball M, Cash RE, Rivard MK, Chrzan K, Panchal AR. Ultrasound Use in the Prehospital Setting for Trauma: A Systematic Review. Prehosp Emerg Care. 2021 Jul-Aug;25(4):566-582. doi: 10.1080/10903127.2020.1811815. Epub 2020 Sep 17.'}]}, 'descriptionModule': {'briefSummary': "The goal of this prospective observational study is to develop and assess the core ultrasound applications for emergency medical technicians (EMTs) in Taiwan. The study focuses on advanced emergency medical technicians (EMT-Ps) and their ability to perform point-of-care ultrasound (POCUS) in prehospital settings.\n\nThe main questions it aims to answer are:\n\nCan a standardized POCUS training program improve EMT-Ps' competency in ultrasound applications? What is the reliability and validity of the newly established POCUS assessment modules for EMT-Ps? Researchers will compare trained EMT-Ps' ultrasound proficiency and clinical decision-making before and after training to see if structured POCUS education enhances diagnostic accuracy and patient care in prehospital settings.\n\nParticipants will:\n\nAttend a structured POCUS training program, including lectures and hands-on practice with standardized patients and simulation models.\n\nUndergo competency assessments, including written exams, objective structured clinical examinations (OSCEs), and image interpretation tests.\n\nPerform ultrasound scans on actual patients in prehospital settings, focusing on trauma, respiratory distress, stroke, and cardiac arrest cases.\n\nReceive feedback and participate in follow-up assessments to evaluate knowledge retention and clinical application."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with one of the following conditions in the prehospital setting:\n\nTrauma Dyspnea (shortness of breath) Suspected stroke Out-of-hospital cardiac arrest (OHCA)\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability or critical conditions requiring immediate resuscitation, making them unsuitable for focused prehospital ultrasound performed by EMT-Ps.\n* Patients under the age of 18.'}, 'identificationModule': {'nctId': 'NCT06950333', 'briefTitle': 'Ultrasound Applications for Emergency Medical Technicians in Taiwan', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Development and Assessment of the Core Ultrasound Applications for Emergency Medical Technicians in Taiwan', 'orgStudyIdInfo': {'id': '202412164RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMT who receive POCUS curriculum', 'description': 'This arm includes certified advanced emergency medical technicians (EMT-P) who are enrolled in a structured point-of-care ultrasound (POCUS) education program developed specifically for prehospital providers in Taiwan. Participants receive a four-hour training module composed of didactic instruction and hands-on practice focused on trauma (FAST), dyspnea (lung ultrasound), suspected stroke (carotid Doppler), and cardiac arrest (focused cardiac ultrasound). Post-training assessments include written exams and objective structured clinical examinations (OSCEs). Participants will also complete follow-up assessments at six months and participate in supervised prehospital ultrasound scanning during real-world EMS missions.', 'interventionNames': ['Other: POCUS education curriculum']}], 'interventions': [{'name': 'POCUS education curriculum', 'type': 'OTHER', 'description': 'The training includes a 4-hour curriculum consisting of a 1-hour didactic session covering ultrasound principles and key applications, followed by 3 hours of hands-on practice using standardized models or phantoms under instructor supervision. Core scanning topics include Focused Assessment with Sonography for Trauma (FAST), lung ultrasound for dyspnea, carotid Doppler for suspected stroke, and focused cardiac ultrasound for cardiac arrest. Post-training assessments include a written test and an Objective Structured Clinical Examination (OSCE).', 'armGroupLabels': ['EMT who receive POCUS curriculum']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wan-Ching Lien, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'dtemer17@yahoo.com.tw', 'phone': '+886-2-23123456', 'phoneExt': '262831'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}