Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-14 @ 11:34 AM
Study NCT ID:
NCT02952768
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency
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': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time of the US image acquisition', 'timeFrame': '6 months', 'description': 'The 6-month evaluation was performed in cardiac arrest patients. The ultrasound operation time was from the time to initiate the ultrasound exam to when the sonographers to inteprete the results, using the ultrasound recorder.'}], 'secondaryOutcomes': [{'measure': 'Learning efficacy was assessed with a written test with 10 multi-choice questions.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The written test with 10 multi-choice questions, including ALS knowledge, and still US image interpretation of C-A-B was performed before and after completion of the course.'}, {'measure': 'A satisfaction survey with a 5-point Likert scale.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The post-course satisfaction survey queried the participants in regards to educational value, knowledge acquisition and self-confidence at the end of the course. The survey consisted of 5 items, using a 5-point Likert scale.'}, {'measure': 'The time of the US image acquisition', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The participants were asked for to produce adequate views of each C-A-B category and consecutive C-A-B exams in the same live model after completion, recorded by the DVD recorder. The time to achieve the views was measured from positioning of the probe on the skin to maintaining an adequate image for at least 3 seconds. The videos were edited that the faces of the participants were covered, and reviewed blindly and independently by the authors. The 6-month evaluation was performed in cardiac arrest patients. The ultrasound operation time was from the time to initiate the ultrasound exam to when the sonographers to inteprete the results, using the ultrasound recorder.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ultrasound Therapy; Complications']}, 'descriptionModule': {'briefSummary': 'Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.\n\nThe US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of cardiac arrest.\n\nA half-day curriculum was designed, and comprised of one-hour didactics and 3-hour small-group hand-on training. Assessments were performed, including a written test, the US image acquisition and a satisfaction survey. From August 1, 2014 to March 31, 2016, the multi-center emergency physicians who attended the US-C-A-B curricula were enrolled prospectively.', 'detailedDescription': 'Ultrasound is a frequently used diagnostic tool in the emergency department and suggested to have a role during resuscitation. The aims of this study were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum and to assess the feasibility.\n\nThe US-C-A-B protocol was built in an advanced life support-compliant manner. It involved a 3-part assessment: (1) C: subxiphoid 4-chamber view of the heart; (2) A: tracheal ultrasound; and (3) B: bilateral lung sliding. It could be used for direct confirmation for the C-A-B and searching the possible cause of'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The enrolled participants were emergency physicians of the National Taiwan University Hospital (NTUH), the Far-Eastern Memorial Hospital (FEMH) and the Chang-Kung Memorial Hospital (CKMH), three teaching hospitals in Taiwan.\n\nExclusion Criteria:\n\n* Not emergency physicians.'}, 'identificationModule': {'nctId': 'NCT02952768', 'briefTitle': 'The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Novel US-C-A-B Protocol: Curriculum Implementation and Evaluation of Proficiency', 'orgStudyIdInfo': {'id': '201505089RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultrasound training', 'description': 'The aims were to develop a novel, resuscitative ultrasound-circulation-airway-breathing (US-C-A-B) protocol, to implement a short curriculum for ultrasound training and to assess the feasibility.', 'interventionNames': ['Behavioral: ultrasound training']}], 'interventions': [{'name': 'ultrasound training', 'type': 'BEHAVIORAL', 'description': 'Through the ultrasound-circulation-airway-breathing training curriculum to integrate the ultrasound into clinical practice.', 'armGroupLabels': ['ultrasound training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wan-Ching Lien, Ph.D.', 'role': 'CONTACT', 'email': 'wanchinglien@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65637'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wan-Ching Lien, Ph. D.', 'role': 'CONTACT', 'email': 'wanchinglien@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65637'}], 'overallOfficials': [{'name': 'Wan-Ching Lien, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}