Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-08 @ 12:51 AM
Study NCT ID:
NCT05940103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality (AR) Hong Kong
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2023-07-02', 'studyFirstSubmitQcDate': '2023-07-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual performance of non-technical skills assessed by Anaesthetist Non-Technical Skills (ANTS)', 'timeFrame': 'immediately after simulation', 'description': 'The Anaesthetist Non-Technical Skills (ANTS) scoring system uses four categories assessing task management, teamworking, situation awareness and decision-making (1 to 4 points by categories). The minimum score is 4 and the maximum 16'}], 'secondaryOutcomes': [{'measure': 'Individual performance of non-technical skills assessed by Behaviorally Anchored Rating Scale (BARS)', 'timeFrame': 'immediately after simulation', 'description': 'The BARS scoring system uses four categories assessing situation awareness, decision-making, communication and teamwork. The score ranges from 1 and 9 (1 = poor and 9 = excellent)'}, {'measure': 'System Usability Scale (SUS) Score', 'timeFrame': 'immediately after simulation', 'description': 'The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)'}, {'measure': 'The International Organization for Standardization (ISO) Ergonomic scale', 'timeFrame': 'immediately after simulation', 'description': 'The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Educational Problems']}, 'descriptionModule': {'briefSummary': 'This is an international, collaborative study evaluating the non-technical skills (NTS) of anesthesiology residents. The goal is to explore the capability of performing a remote, international AR simulation for the purpose of assessing PALS during a medical crisis. Simulation experts in the United States will facilitate the AR simulations with anesthesiology residents in Hong Kong. The medical simulation itself is grounded in traditional best practices in accordance with the American Heart Association.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18\n\nExclusion Criteria:\n\n* a history of severe motion sickness\n* currently have nausea, a history of seizures\n* wear corrective glasses (they are not compatible with the AR hardware).'}, 'identificationModule': {'nctId': 'NCT05940103', 'briefTitle': 'Augmented Reality (AR) Hong Kong', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'International Training of Non-Technical Medical Crisis Skills Using Remote, Augmented Reality Simulation', 'orgStudyIdInfo': {'id': '71248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixed Reality Simulation', 'description': 'Participants in the experimental arm will be introduced to workplace training modules through an Augmented Reality (AR) headset.', 'interventionNames': ['Other: Augmented Reality (AR)']}], 'interventions': [{'name': 'Augmented Reality (AR)', 'type': 'OTHER', 'description': 'AR headset - a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario', 'armGroupLabels': ['Mixed Reality Simulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': "Lucile Parkard Children's Hospital", 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Lydia Lau, MD', 'role': 'CONTACT'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Thomas J Caruso, MD, PhD', 'role': 'CONTACT', 'email': 'tjcaruso@stanford.edu', 'phone': '650-723-5728'}, {'name': 'Man Yee Suen, MMedSc', 'role': 'CONTACT', 'email': 'msuen@stanfordchildrens.org', 'phone': '650-723-5728'}], 'overallOfficials': [{'name': 'Thomas J Caruso, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Thomas Caruso', 'investigatorAffiliation': 'Stanford University'}}}}