Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2026-02-25 @ 7:27 PM
Study NCT ID:
NCT06485518
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integration of the 5G-based Remote Healthcare System in Critical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'critical conditions', 'timeFrame': 'from July 2022 to June 2023', 'description': 'For all patients receiving care through the 5G RHS platform during the specified time period, we gathered clinical data from electronic health records (EHRs). This data encompasses information related to critical conditions.'}, {'measure': 'background situation', 'timeFrame': 'from July 2022 to June 2023', 'description': 'For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to the emergency situation,'}, {'measure': 'reasons for consultation', 'timeFrame': 'from July 2022 to June 2023', 'description': 'For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to reasons for seeking remote consultation (including complex challenges, new medical scenarios, and educational interactions).'}, {'measure': 'treatment outcomes', 'timeFrame': 'from July 2022 to June 2023', 'description': 'For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to treatment outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teleconference', 'Mentoring', 'Augmented Reality', 'Emergency', 'Patient outcome'], 'conditions': ['Emergency Medicine', 'Telemedicine', 'Augmented Reality']}, 'descriptionModule': {'briefSummary': 'The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific improvements in various use cases (e.g., emergency room, diagnosis, treatment, task guidance, and medical education) and to examine whether factors such as the expertise of central physicians, patient and physician locations, and the timing of calls influence clinical outcomes.', 'detailedDescription': 'Background: Augmented Reality (AR) has undergone rapid development in recent years, gaining prominence in healthcare, especially when coupled with 5G internet technology. This study delves into the integration of 5G Augmented Reality in emergency medicine, with a focus on its impact on clinical outcomes.\n\nMethods: This study will utilize the 5G-based Remote Healthcare System (5G RHS) to connect four satellite Emergency Room (ER) teams with central experts to assess its effectiveness in critical cases. Data will be collected from July 2022 to June 2023 to address key research questions, including the circumstances prompting the use of 5G RHS, the extent of clinical improvement achieved, and the influence of central physician expertise, patient and physician locations, and calling time on clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, patients with acute chest pain, stroke and trauma will be enrolled in the departments of emergency medicine in the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age range (≥18 years old).\n* 2\\) Patients with acute chest pain, stroke and trauma were diagnosed in the departments of emergency medicine of the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.\n* 3\\) Voluntarily participate in the study and sign the informed consent; If the subject does not have the ability to understand or sign the informed consent, his/her guardian will represent him/her in the informed process and agree to participate in the study; If illiterate, his/her will need a witness to witness the knowledge process and his/her will decide to participate in the study.\n\nExclusion Criteria:\n\n* 1\\) Incomplete clinical data.\n* 2\\) Minors.\n* 3\\) Pregnant women.'}, 'identificationModule': {'nctId': 'NCT06485518', 'acronym': 'IT5GRHSCI', 'briefTitle': 'Integration of the 5G-based Remote Healthcare System in Critical Care', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Integration of the 5G-based Remote Healthcare System in Critical Care: A Comprehensive Report With Multiple Satellite Sites', 'orgStudyIdInfo': {'id': 'ky20220304-31'}, 'secondaryIdInfos': [{'id': '2023YFC3603100', 'type': 'OTHER_GRANT', 'domain': 'National Key Research and Development Program of China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '5G RHS group', 'description': 'For all patients receiving care through the 5G-based Remote Healthcare System (5G RHS) teleconsultation platform during the specified time period', 'interventionNames': ['Behavioral: The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.']}], 'interventions': [{'name': 'The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.', 'type': 'BEHAVIORAL', 'description': 'The 5G RHS group will receive audio-video conferencing and effective data management for decision-making via augmented reality platform. A total of 14 physicians from SRRSH will be participated in the study, offering remote consultations and instant guidance to the physician.', 'armGroupLabels': ['5G RHS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310012', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yecheng Jin, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '1. The data are not publicly available due to their containing information that could compromise the privacy of research participants.\n2. Data cannot be shared openly but are available on request from authors for some reasonable conditions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Yucai Hong', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}