Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2026-01-09 @ 10:20 PM
Study NCT ID:
NCT01870661
Status:
WITHDRAWN
Last Update Posted:
2014-06-25
First Post:
2013-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2013-06-03', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catheter survival', 'timeFrame': '3 days', 'description': 'How many catheters survived for 3 days or as long as they are needed.'}], 'secondaryOutcomes': [{'measure': 'Need for central venous access', 'timeFrame': 'for 3 days'}, {'measure': 'success rate of peripheral IV using ultrasound assistance', 'timeFrame': '30 minutes'}, {'measure': 'Complication rate', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intravenous placement', 'Ultrasound'], 'conditions': ['Need for IV Access']}, 'descriptionModule': {'briefSummary': 'Comparison of peripheral IV catheters inserted by ultrasound using the long axis vs. the short axis technique. Our hypothesis is that long axis ultrasound placement will increase the longevity of the IV catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient who needs PIV access for intravenous medications and resuscitation either on a medical-surgical floor or in the ICU\n* After floor team (including RN and/or house staff) and IV Nurse have attempted and failed or is not available\n\nExclusion Criteria:\n\n* Need for vasopressors\n* Need for TPN\n* Need for hemodynamic monitoring\n* Non English speaking patient\n* Patients who are unable to consent'}, 'identificationModule': {'nctId': 'NCT01870661', 'briefTitle': 'Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Medical Center'}, 'officialTitle': 'Ultrasound Guided Peripheral Intravenous Catheter Insertion in the Hospitalized Patient: Long vs. Short Axis Placement', 'orgStudyIdInfo': {'id': '035-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long axis ultrasound placement of IV', 'description': 'Long axis ultrasound placement of IV catheter', 'interventionNames': ['Device: Long axis IV placement with ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short axis ultrasound placement of IV', 'description': 'Long axis ultrasound placement of IV catheter', 'interventionNames': ['Device: Short axis IV placement with ultrasound']}], 'interventions': [{'name': 'Long axis IV placement with ultrasound', 'type': 'DEVICE', 'description': 'Peripheral IV placement with the ultrasound probe viewing the vessel in the long axis.', 'armGroupLabels': ['Long axis ultrasound placement of IV']}, {'name': 'Short axis IV placement with ultrasound', 'type': 'DEVICE', 'description': 'Peripheral IV placement with the ultrasound probe viewing the vessel in the short axis.', 'armGroupLabels': ['Short axis ultrasound placement of IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Isreal Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael Silverberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}