Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01276158
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2011-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric Radial Arterial Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary object is to compare the first attempt success rate between each group.', 'timeFrame': '10 minutes'}], 'secondaryOutcomes': [{'measure': 'As a secondary object, a comparison will be made between groups for overall Success rate within a 10 minute time period.', 'timeFrame': '10 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.', 'detailedDescription': 'In infants, percutaneous cannulation of radial artery requires considerable expertise. People have been using Doppler guided radial artery cannulation technique to improve success rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central line placement in pediatrics. The purpose of this study is whether ultrasound guided radial artery cannulation technique improves the success rate compared to traditional doppler guided technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria\n\n 1. Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring\n 2. Term neonates and children \\< 4 years old weighing \\>/= 3 kg and \\< 12 kg\n\nExclusion Criteria:\n\n* Exclusion criteria\n\n 1. Patients with a skin wound or infection around puncture site\n 2. Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill)\n 3. Recent radial arterial puncture (less than 1 month)\n 4. Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.'}, 'identificationModule': {'nctId': 'NCT01276158', 'briefTitle': 'Pediatric Radial Arterial Cannulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Ultrasound-image Versus Doppler-guided Radial Artery Cannulation in Infants and Small Children', 'orgStudyIdInfo': {'id': '200905711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound', 'description': 'Arterial line placed with Ultrasound guidance.', 'interventionNames': ['Procedure: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doppler', 'description': 'Arterial line placed with doppler guidance', 'interventionNames': ['Procedure: Doppler']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound used to place arterial line', 'armGroupLabels': ['Ultrasound']}, {'name': 'Doppler', 'type': 'PROCEDURE', 'description': 'Doppler used to place arterial line', 'armGroupLabels': ['Doppler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Kenichi Ueda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Kenichi Ueda', 'investigatorAffiliation': 'University of Iowa'}}}}