Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06013904
Status:
WITHDRAWN
Last Update Posted:
2025-07-04
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Difficult PIV Placement in the Pediatric ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The logistics of the study made it too challenging to conduct within a pediatric setting.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2023-08-22', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to placement', 'timeFrame': 'During the patient 1 day visit, time to placement will be time from obtaining consent to successful IV placement saline flush.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric ALL']}, 'descriptionModule': {'briefSummary': "Insertion of peripheral intravenous (PIV) lines is one of the most common procedures in the Pediatric Emergency Department (ED). Faster placement of PIV lines can decrease time to intervention, as well overall time patients spend in the ED. Using ultrasound (US) guidance has been shown to increase the rate of first attempt success from around 50% to 78-85% compared to traditional methods of placing PIVs. The Pediatric ED at DCMC has US-trained nurses who assist in placing PIVs in patients with difficult access. Per ED shift, there is an average of 4-6 patients that are considered difficult access. However, because of nursing shortages and the general increased patient flow in the DCMC ED, there may not be a US-trained nurse available when a difficult access patient needs to have a PIV placed during a shift. This can lead to an increase in waiting time for the patient and delayed care.\n\nAt the DCMC ED, if the first attempt at placing a PIV is not successful, an algorithm for a level of escalation (i.e., which hospital personnel should attempt subsequent placements and maximum number of attempts) is followed. Attempt at PIV placement for most patients in the ED can be made by a patient care technician, RN, beside nurse, or charge nurse. If the PIV placement is not successful after two tries or if the patient has known risk factors that will complicate the PIV placement, the PIV placement is escalated to more experienced personnel, which includes US-trained nurses. For the purposes of this protocol, we will refer to these patients and personnel as Level 2 placements.\n\nPediatric emergency medicine (PEM) is a clinical subspecialty that focuses on caring for complicated and acutely ill pediatric patients in the emergency department. In partnership with Ascension Seton Dell Children's Medical Center, UT Austin's Dell Medical School PEM Fellowship is a rigorous program where Fellows are offered a broad experience in all facets of pediatric emergency medicine¸ including clinical care, teaching, research, and administration. A cohort of 12 Fellows are currently part of the program and could be trained to administer PIV via US, being available to place PIVs in patients with difficult access when a US-trained nurse is not available. We hypothesize that adding Pediatric Emergency Medicine (PEM) Fellows to the rotation of personnel who can insert IVs for pediatric patients with difficult access will shorten time to successful peripheral intravenous (PIV) placement overall in the Dell Children's Medical Center (DCMC) Emergency Department (ED)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 0-17\n2. Patient meets difficult/escalated PIV criteria\n3. English- or Spanish-speaking parent/guardian\n\nExclusion Criteria:\n\n1. Critical illness presentation, such as sepsis.\n2. Emergent medical situation, such as airway compromise, code, status epileptics, etc.'}, 'identificationModule': {'nctId': 'NCT06013904', 'briefTitle': 'Difficult PIV Placement in the Pediatric ED', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Can a Team of Ultrasound-Trained ED Physicians Reduce the Time to IV Placement for Children With Difficult IV Access?', 'orgStudyIdInfo': {'id': '00004870'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual difficult PIV placement personnel', 'description': 'Patients randomized to this arm will follow the usual protocol for difficult IV placement (ultrasound-trained nurses) in the pediatric ED.', 'interventionNames': ['Procedure: Difficult PIV placement personnel']}, {'type': 'EXPERIMENTAL', 'label': 'US-trained PEM Fellows', 'description': 'Patients randomized to this arm will have a trained PEM fellow place the difficult PIV in the pediatric ED.', 'interventionNames': ['Procedure: US-trained PEM Fellows']}], 'interventions': [{'name': 'Difficult PIV placement personnel', 'type': 'PROCEDURE', 'description': 'Patients randomized to this group will have their difficult PIV placed following the usual protocol for pediatric ED patients.', 'armGroupLabels': ['Usual difficult PIV placement personnel']}, {'name': 'US-trained PEM Fellows', 'type': 'PROCEDURE', 'description': 'US-trained PEM Fellows', 'armGroupLabels': ['US-trained PEM Fellows']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthew Wilkinson, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Texas at Austin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Lina Palomares', 'investigatorAffiliation': 'University of Texas at Austin'}}}}