Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05961358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014160', 'term': 'Transducers, Pressure'}], 'ancestors': [{'id': 'D014159', 'term': 'Transducers'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-17', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of mobile device analysis results with Vigileo analysis results', 'timeFrame': '1 day', 'description': 'Cardiac output and Stroke Volume Variation were acquired by mobile device and Vigileo'}, {'measure': 'Comparison of arterial waveform collected directly analysis results and Vigileo analysis results', 'timeFrame': '1 day', 'description': 'Cardiac output and Stroke Volume Variation were acquired by Vigileo and arterial waveform collected directly analysis'}, {'measure': 'Comparison of arterial waveform collected directly analysis results and mobile device analysis results', 'timeFrame': '1 day', 'description': 'Cardiac output and Stroke Volume Variation were acquired by mobile device and arterial waveform collected directly analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arterial blood pressure', 'cardiac output', 'advanced hemodynamic', 'mobile Applications'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'In this study, the arterial blood pressure waveform was digitized by snapshots or videos of the patient monitor to further estimate advanced hemodynamic parameters, so as to realize continuous and automatic monitoring of advanced hemodynamics on mobile devices to assist anesthesia, with a view to developing an Android/iOS application for mobile devices and application in patient management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. The study participants will be adult general anesthesia patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive blood pressure monitoring\n* Aged 18-65 years\n* ASA class I-III\n\nExclusion Criteria:\n\n* Spontaneous breathing\n* Prone position\n* Non-radial artery cannulation\n* Aortic regurgitation\n* Heart arrhythmia\n* Heart rate \\> 100/min\n* Intra-aortic balloon pump\n* Peripheral vascular disease\n* Body weight \\< 40 kg'}, 'identificationModule': {'nctId': 'NCT05961358', 'briefTitle': 'Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Auxiliary Anesthesia Technique for Extracting Advanced Hemodynamic Parameters Based on Peripheral Arterial Waveform Photography', 'orgStudyIdInfo': {'id': '2023-0554'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anesthesia Patients', 'description': 'Subjects experiencing general anesthesia', 'interventionNames': ['Procedure: snapshots or videos of monitor', 'Procedure: Pressure transducer']}], 'interventions': [{'name': 'snapshots or videos of monitor', 'type': 'PROCEDURE', 'description': 'The mobile device（a phone）was used to obtain the screen image of the monitor, and the arterial blood pressure waveform is extracted by image processing technology.', 'armGroupLabels': ['General anesthesia Patients']}, {'name': 'Pressure transducer', 'type': 'PROCEDURE', 'description': 'Arterial catheter were connected to conventional pressure transducers and Flotrac-Vigileo transducers.', 'armGroupLabels': ['General anesthesia Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University anesthesiology department', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}