Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT06114433
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three-dimensional Upper Gastrointestinal Tract Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-10-28', 'studyFirstSubmitQcDate': '2023-10-28', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examination score of direct observation of procedural skills', 'timeFrame': 'immediately after the intervention', 'description': 'maximun 100 and minimum 0, higher means a better outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D printing', 'upper body manikin', 'upper gastrointestinal tract', 'nasogastric tube care', 'simulation-based training'], 'conditions': ['Medical Education']}, 'descriptionModule': {'briefSummary': 'This study aims to develop an upper body manikin with a high-fidelity upper gastrointestinal tract and apply into the nasogastric tube training program for nursing students.', 'detailedDescription': 'Background：\n\nNursing trainees often fail to correctly prepare medical supplies and use stethoscopes for position assessment incorrectly when physicians perform nasogastric tube placement techniques. The traditional training model are expensive and difficult to access or maintain. It is easy to cause irreparable damage when repeated tearing and sticking of the elastic adhesive tape on the traditional model. Because of the high-priced the traditional model, it is impossible to use real milk, to simulate the nasogastric tube feeding. Inadequate clinical skills often raises patient safety concerns when assisting in changing nose pads and feeding. To enhance the nasogastric tube training for nursing students, the investigators used 3D-printed education model combined with clinical simulation-based training program.\n\nStudy Design：\n\nThis is a randomized controlled trial of medical education study.\n\nMethods：\n\nThe investigators first designed our 3D upper body model using the 3D processing and analysis software. To create the basic outline of the 3D model, the investigators used a white-light handheld 3D scanner to scan a real human. To closely resemble the soft biological tissues of real human organs, an adequate material will be chosen in the study. The pre/post examination, student satisfaction, and direct observation of procedural skills will be used to evaluation the outcome of the study.\n\nEffect：\n\nThe investigators expect the 3D-printed upper body manikin with a high-fidelity upper gastrointestinal tract model has potential in nasogastric tube training, particularly in helping trainees become familiar with the nasogastric tube care.\n\nKeywords：\n\n3D printing, upper body manikin, upper gastrointestinal tract, nasogastric tube care, simulation-based training'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Training at Fu Jen Catholic University Hospital.\n* Signed the consent form.\n\nExclusion Criteria:\n\n* Refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06114433', 'briefTitle': 'Three-dimensional Upper Gastrointestinal Tract Model', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Development of 3D Printing High-Fidelity Upper Gastrointestinal Tract Model for Nursing Students in the Nasogastric Tube Training', 'orgStudyIdInfo': {'id': 'FJUH111192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional model group', 'description': 'Received a regular learning', 'interventionNames': ['Other: Traditional model education']}, {'type': 'EXPERIMENTAL', 'label': '3D-printed presention group', 'description': 'Received a regular learning plus 3D printing model', 'interventionNames': ['Other: 3D printed educational model']}], 'interventions': [{'name': '3D printed educational model', 'type': 'OTHER', 'description': 'Slide-based presention plus 3D printed educational model', 'armGroupLabels': ['3D-printed 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', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.com', 'phone': '+886-905-301-879'}, {'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], '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'}}}}