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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06013904
Other study ID # 00004870
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2023
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source University of Texas at Austin
Contact Lina Palomares, LMSW
Phone 818-207-3724
Email lina.palomares@austin.utexas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: 1. Age 0-17 2. Patient meets difficult/escalated PIV criteria 3. English- or Spanish-speaking parent/guardian Exclusion Criteria: 1. Critical illness presentation, such as sepsis. 2. Emergent medical situation, such as airway compromise, code, status epileptics, etc.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Difficult PIV placement personnel
Patients randomized to this group will have their difficult PIV placed following the usual protocol for pediatric ED patients.
US-trained PEM Fellows
US-trained PEM Fellows

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Outcome

Type Measure Description Time frame Safety issue
Primary Time to placement During the patient 1 day visit, time to placement will be time from obtaining consent to successful IV placement saline flush.
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