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WITHDRAWN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:
University of Texas at Austin
Organization:
Study Overview
Official Title:
Can a Team of Ultrasound-Trained ED Physicians Reduce the Time to IV Placement for Children With Difficult IV Access?
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The logistics of the study made it too challenging to conduct within a pediatric setting.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: