Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-26 @ 8:15 AM
Study NCT ID:
NCT03845361
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Artery Cannulation and Perfusion Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2019-02-17', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The perfusion index', 'timeFrame': 'Intraoperative'}, {'measure': 'The peripheral temperature', 'timeFrame': 'Intraoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perfusion index', 'Cardiac Surgery', 'Radial artery cannulation'], 'conditions': ['Peripheral Perfusion']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.', 'detailedDescription': 'Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.\n\nPerfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.\n\nthis study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cardiac surgery using cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Peripheral vascular diseases\n* previous upper limb surgeries\n* planned radial artery harvesting'}, 'identificationModule': {'nctId': 'NCT03845361', 'briefTitle': 'Radial Artery Cannulation and Perfusion Index', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.', 'orgStudyIdInfo': {'id': 'Radial perfusion index'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C. hand', 'description': 'Radial artery cannulation', 'interventionNames': ['Procedure: Radial artery cannulation']}, {'type': 'NO_INTERVENTION', 'label': 'N.C. hand', 'description': 'No cannulation of the radial artery'}], 'interventions': [{'name': 'Radial artery cannulation', 'type': 'PROCEDURE', 'description': 'Radial artery cannulation', 'armGroupLabels': ['C. hand']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hany Mostafa Esmaeil Osman', 'investigatorAffiliation': 'Assiut University'}}}}