Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01100593
Status:
COMPLETED
Last Update Posted:
2012-11-02
First Post:
2010-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound IV Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2010-04-07', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extravasation rates', 'timeFrame': '48 hours', 'description': 'compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'IV catheters', 'Extravasation'], 'conditions': ['IV Access', 'Ultrasound Use']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare catheter length and extravasation rates for Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.', 'detailedDescription': 'The purpose of this study is to compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.\n\nThe study design is a randomized non-blinded clinical trial of extravasation rates of US guided peripheral vascular access related to intravenous catheter length and venous depth in the ED. Primary endpoint is duration of usable vascular access. Secondary endpoints are catheter length, venous depth, time of procedure, successful cannulation, reasons for failure, number of skin punctures, site of cannulation, sonographic technique, type of provider obtaining access and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* two failed traditional IV attempts by a nurse\n* need for IV access as determined by the treating physician\n* age 18 and greater\n\nExclusion Criteria:\n\n* less than age 18\n* subjects needing a central venous catheter\n* patients unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01100593', 'briefTitle': 'Ultrasound IV Study', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Optimal Catheter Length for Ultrasound-Guided Peripheral Vascular Access', 'orgStudyIdInfo': {'id': '28195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.75 inch catheter length', 'description': 'Length of catheter to be used', 'interventionNames': ['Procedure: length of IV catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2.5 inch catheter length', 'description': 'length of catheter to be used', 'interventionNames': ['Procedure: length of IV catheter']}], 'interventions': [{'name': 'length of IV catheter', 'type': 'PROCEDURE', 'description': 'Subjects will be randomized to one of two IV catheter lengths', 'armGroupLabels': ['1.75 inch catheter length', '2.5 inch catheter length']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Paul Sierzenski, MD, RDMS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Christiana Care Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}