Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06171035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of 3D Printing High-fidelity Craniofacial Manikin to Teach Noninvasive Positive Pressure Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-19', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examination score of pre-intervention', 'timeFrame': 'pre-intervention', 'description': 'score of pre-intervention (maximun 100 and minimum 0), higher means a better outcome.'}, {'measure': 'Examination score of post-intervention', 'timeFrame': 'immediately after the intervention', 'description': 'score of post-intervention (maximun 100 and minimum 0), higher means a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D printing', 'medical education model', 'high-fidelity simulation', 'respiratory care'], 'conditions': ['Satisfaction, Personal']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to enhance the learning efficiency and ability of problem-solving for student of Department of Respiratory Therapy with the innovative 3D printing high-fidelity manikin.', 'detailedDescription': "Background :\n\nNoninvasive positive pressure ventilation plays an important role in treatment of respiratory failure. Respiratory Therapists should be familiar with operating ventilator, choosing the adequate interface, and putting the interface on patients' face correctly. Simulation-based clinical training was limited because of lack of the high-fidelity manikins or simulators. To enhance the simulation-based clinical training, the investigators develop 3D printing models and applied into the medical school and hospital training.\n\nStudy Design :\n\nThe first part is a laboratory in-vitro experiment; the second part is a randomized controlled trial of medical education study.\n\nMethods :\n\nThe 3D scanning and 3D printing technology will be using to create the high-fidelity manikin with an upper and lower airway tract. The 3D printing material will be choosing to be able to close real human organ especially considering the soft biological tissue. The present study will be divided into two parts. The first part is a laboratory in-vitro experiment, which aims to verified the function of the high-fidelity manikin; the second part is a medical education study.\n\nEffect :\n\nThe investigators expect the use of 3D high-fidelity model in training students of Department of Respiratory Therapy will enhance the learning efficiency and ability of problem-solving.\n\nThe experience and outcome of the study will further extent to medical school and hospital training.\n\nKey words:\n\n3D printing; medical education model; high-fidelity simulation; respiratory care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student of Fu Jen Catholic University\n\nExclusion Criteria:\n\n* Refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06171035', 'briefTitle': 'Use of 3D Printing High-fidelity Craniofacial Manikin to Teach Noninvasive Positive Pressure Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Use of 3D Printing High-fidelity Airway and Craniofacial Manikin as an Education Tool to Improve Learning Efficiency of Teaching Noninvasive Positive Pressure Ventilation', 'orgStudyIdInfo': {'id': 'FJUH111188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional model group', 'description': 'Received a regular learning', 'interventionNames': ['Other: Traditional model education']}, {'type': 'EXPERIMENTAL', 'label': '3D-printed high-fidelity craniofacial manikin model presention group', 'description': 'Received a regular learning plus 3D printing model', 'interventionNames': ['Other: 3D-printed high-fidelity craniofacial manikin model education']}], 'interventions': [{'name': '3D-printed high-fidelity craniofacial manikin model education', 'type': 'OTHER', 'description': 'Slide-based presention plus 3D printed model', 'armGroupLabels': ['3D-printed high-fidelity craniofacial manikin model presention group']}, {'name': 'Traditional model education', 'type': 'OTHER', 'description': 'Slide-based presention plus traditional model', 'armGroupLabels': ['Traditional model group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'C00152@mail.fjuh.fju.edu.tw', 'phone': '+886905301879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Group leader of Respiratory Therapists', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}