Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-31 @ 4:01 PM
Study NCT ID:
NCT03294993
Status:
WITHDRAWN
Last Update Posted:
2021-11-11
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture
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': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change of Peak Systolic Velocity', 'timeFrame': 'baseline and 30 minutes after surgery', 'description': 'The Change of Peak Systolic Velocity before and after surgery'}], 'secondaryOutcomes': [{'measure': 'the change of modified Allen test', 'timeFrame': 'baseline and 30 minutes after surgery', 'description': 'the change of modified Allen test before and after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Flow Indexes']}, 'descriptionModule': {'briefSummary': 'The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography', 'detailedDescription': 'The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography.The indexes include Arterial Diameter,Peak Systolic Velocity,End Diastolic Velocity,Resistive Index,Pulsatility Index,Systolic/End Diastolic Ratio,Time AverageMean Velocity and Blood Flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients were included in the study if they were ethnic Chinese, between 18 and 65 years old, American Society of Anesthesiologists (ASA) physical status I or II,candidates for general anesthesia undergoing thoracic surgery\n\nExclusion Criteria:\n\n* Patients were excluded if they do not want to cooperate with the test, had a history of upper extremity arteriosclerosis obliterans or thromboangitis obliterans,had a history of radial artery puncture or coronary artery bypass grafting,had acute vessel trauma,or had been diagnosed with Raynaud' disease,had suffered from mental or neurological disorders"}, 'identificationModule': {'nctId': 'NCT03294993', 'briefTitle': 'Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'Doppler Ultrasonography Assessed Vascular Changes Before and After Radial Artery Puncture', 'orgStudyIdInfo': {'id': '20170711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound assess group', 'description': 'The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography', 'interventionNames': ['Device: Ultrasound assess']}], 'interventions': [{'name': 'Ultrasound assess', 'type': 'DEVICE', 'description': 'The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography', 'armGroupLabels': ['Ultrasound assess group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'the First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Hong Ma, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate proffesor', 'investigatorFullName': 'Wen-fei Tan', 'investigatorAffiliation': 'China Medical University, China'}}}}