Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-01 @ 8:21 AM
Study NCT ID:
NCT01605292
Status:
COMPLETED
Last Update Posted:
2015-02-26
First Post:
2012-01-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radial Artery Access With Ultrasound Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arnold.seto@va.gov', 'phone': '(562) 826-8000', 'title': 'Arnold Seto, MD, MPA', 'phoneExt': '5486', 'organization': 'Long Beach VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Blinding was not possible in this study. We cannot exclude a bias in the performance, measurement, or recording of the procedure or clinical data. Time to prepare the US probe was not included in the time to access.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.', 'otherNumAtRisk': 351, 'otherNumAffected': 0, 'seriousNumAtRisk': 351, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.', 'otherNumAtRisk': 347, 'otherNumAffected': 0, 'seriousNumAtRisk': 347, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '1.65', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately during procedure. (up to 30 minutes)', 'description': 'Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.', 'unitOfMeasure': 'forward attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts.'}, {'type': 'SECONDARY', 'title': 'Time to Sheath Insertion (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'spread': '112', 'groupId': 'OG000'}, {'value': '88', 'spread': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately during procedure (within 30 minutes)', 'description': 'Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First-pass Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'title': 'Successful first-pass', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Unsuccessful first-pass', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate', 'description': 'Proportion of procedures achieving access on the first attempt', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of patients with accurate number of attempts measured'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Radial Artery Spasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately during procedure (within 30 min)', 'description': 'Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difficult Access Procedures >= 5 Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'title': '>=5 attempts', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '<5 attempts', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately during procedure (within 30 min)', 'description': 'Difficult procedures were defined as either requiring \\>= 5 attempts', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difficult Access >= 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'title': '>= 5 minutes', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '< 5 minutes', 'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate (within 30 minutes)', 'description': 'Access that requires \\>= 5 minutes from first attempt to sheath insertion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bleeding Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'After procedure (within 24 hours)', 'description': 'Any hematoma \\>2 cm or bleeding requiring intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Crossover to Ultrasound Rescue Attempts After 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'title': 'Successful rescue with ultrasound', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Unsuccessful rescue with ultrasound', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 minutes', 'description': 'Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to palpation could potentially cross over to ultrasound technique.'}, {'type': 'POST_HOC', 'title': 'Failure of Radial Sheath Insertion With Original Randomized Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'OG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2-8 hours after procedure', 'description': 'Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'FG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '351'}, {'groupId': 'FG001', 'numSubjects': '347'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '351'}, {'groupId': 'FG001', 'numSubjects': '347'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'BG000'}, {'value': '347', 'groupId': 'BG001'}, {'value': '698', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.\n\nPalpation: Manual palpation for localizing radial artery for inserting needle.'}, {'id': 'BG001', 'title': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.\n\nUltrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '516', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Outpatient', 'classes': [{'title': 'Outpatient', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}]}, {'title': 'Inpatient or admitted', 'categories': [{'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Obesity, BMI >= 30', 'classes': [{'title': 'Obese', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}]}]}, {'title': 'Nonobese', 'categories': [{'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertension', 'classes': [{'title': 'HTN', 'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '597', 'groupId': 'BG002'}]}]}, {'title': 'Non-HTN', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypercholesterolemia', 'classes': [{'title': 'Hypercholesterolemia', 'categories': [{'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}]}, {'title': 'Normal cholesterol', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes mellitus', 'classes': [{'title': 'DM', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}, {'title': 'No DM', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tobacco', 'classes': [{'title': 'Tobacco use', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}, {'title': 'No tobacco use', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Peripheral vascular disease', 'classes': [{'title': 'PVD', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'No PVD', 'categories': [{'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '668', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Barbeau class B or C', 'classes': [{'title': "Barbeau's Class A", 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': "Barbeau's Class B or C", 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': "Of those patients receiving Barbeau's test. Barbeau's Class A reflects no reduction of arterial waveform on pulse oximetry after radial artery occlusion, indicating robust collateral flow from the ulnar artery. Barbeau's Class B and C reflect delayed but eventual recovery of arterial waveform on pulse oximetry after radial artery occlusion, indicating the presence of some but limited collaterals from the ulnar artery. Barbeau's Class D patients (no demonstrable collaterals) were excluded from the study.", 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 698}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2012-01-26', 'resultsFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2012-05-22', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-25', 'studyFirstPostDateStruct': {'date': '2012-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Radial Artery Spasm', 'timeFrame': 'Immediately during procedure (within 30 min)', 'description': 'Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation'}, {'measure': 'Difficult Access Procedures >= 5 Attempts', 'timeFrame': 'Immediately during procedure (within 30 min)', 'description': 'Difficult procedures were defined as either requiring \\>= 5 attempts'}, {'measure': 'Difficult Access >= 5 Minutes', 'timeFrame': 'Immediate (within 30 minutes)', 'description': 'Access that requires \\>= 5 minutes from first attempt to sheath insertion'}, {'measure': 'Bleeding Complication', 'timeFrame': 'After procedure (within 24 hours)', 'description': 'Any hematoma \\>2 cm or bleeding requiring intervention'}, {'measure': 'Pain Score', 'timeFrame': '2-8 hours after procedure', 'description': 'Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.'}], 'primaryOutcomes': [{'measure': 'Number of Attempts', 'timeFrame': 'Immediately during procedure. (up to 30 minutes)', 'description': 'Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.'}], 'secondaryOutcomes': [{'measure': 'Time to Sheath Insertion (Seconds)', 'timeFrame': 'Immediately during procedure (within 30 minutes)', 'description': 'Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.'}, {'measure': 'First-pass Success Rate', 'timeFrame': 'Immediate', 'description': 'Proportion of procedures achieving access on the first attempt'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transradial catheterization', 'Ultrasound', 'Radial artery'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '25596790', 'type': 'RESULT', 'citation': 'Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.'}, {'pmid': '34637140', 'type': 'DERIVED', 'citation': 'Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients presenting for cardiac or peripheral catheterization with planned radial approach.\n* Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels\n* Functional ultrasound equipment with ultrasound trained attending operator\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Femoral access\n* Emergency procedure (Shock, STEMI)\n* End-stage renal disease on hemodialysis\n* Previous ipsilateral puncture within 1 week"}, 'identificationModule': {'nctId': 'NCT01605292', 'acronym': 'RAUST', 'briefTitle': 'Radial Artery Access With Ultrasound Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Radial Artery Access With Ultrasound Trial', 'orgStudyIdInfo': {'id': '2011-8432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palpation', 'description': 'Manual palpation of radial pulse, as sole guide to needle cannulation.', 'interventionNames': ['Procedure: Palpation']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound', 'description': 'Real-time ultrasound guidance to facilitate needle cannulation of artery.', 'interventionNames': ['Procedure: Ultrasound guidance']}], 'interventions': [{'name': 'Ultrasound guidance', 'type': 'PROCEDURE', 'description': 'Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.', 'armGroupLabels': ['Ultrasound']}, {'name': 'Palpation', 'type': 'PROCEDURE', 'description': 'Manual palpation for localizing radial artery for inserting needle.', 'armGroupLabels': ['Palpation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '11418', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Jamaica Hospital', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma VA Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Arnold H Seto, MD, MPA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine and Long Beach VA Medical Center'}, {'name': 'Zoran Lasic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lenox Hill Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lenox Hill Hospital', 'class': 'OTHER'}, {'name': 'Jamaica Hospital Medical Center', 'class': 'OTHER'}, {'name': 'Oklahoma City VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Arnold Seto', 'investigatorAffiliation': 'University of California, Irvine'}}}}