Difficult PIV Placement in the Pediatric ED

NCT06013904 | Withdrawn

• 1 other identifier: 00004870
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. At 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. Pediatric 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).

Conditions

Pediatric ALL

Outcome Measures

Primary Outcomes (1)

• Time to placement

  During the patient 1 day visit, time to placement will be time from obtaining consent to successful IV placement saline flush.

Study Arms (2)

Usual difficult PIV placement personnel

ACTIVE COMPARATOR

Patients randomized to this arm will follow the usual protocol for difficult IV placement (ultrasound-trained nurses) in the pediatric ED.

Procedure: Difficult PIV placement personnel

US-trained PEM Fellows

EXPERIMENTAL

Patients randomized to this arm will have a trained PEM fellow place the difficult PIV in the pediatric ED.

Procedure: US-trained PEM Fellows

Interventions

Difficult PIV placement personnel PROCEDURE

Patients randomized to this group will have their difficult PIV placed following the usual protocol for pediatric ED patients.

Usual difficult PIV placement personnel

US-trained PEM Fellows PROCEDURE

US-trained PEM Fellows

US-trained PEM Fellows

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 0-17
• Patient meets difficult/escalated PIV criteria
• English- or Spanish-speaking parent/guardian

You may not qualify if:

• Critical illness presentation, such as sepsis.
• Emergent medical situation, such as airway compromise, code, status epileptics, etc.

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Matthew Wilkinson, MD, MPH

  The University of Texas at Austin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: June 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share