First-Attempt Success in Ultrasound-Guided vs Standard Peripheral Intravenous Catheter Insertion: The EPIC Superiority Randomized Clinical Trial.

Abstract

Importance: Pediatric peripheral intravenous catheter (PIVC) insertion can be difficult and time-consuming, frequently requiring multiple insertion attempts and often resulting in increased anxiety, distress, and treatment avoidance among children and their families. Ultrasound-guided PIVC insertion is a superior alternative to standard technique (palpation and visualization) in high-risk patients.

Objective: To compare first-time insertion success of PIVCs inserted with ultrasound guidance compared with standard technique (palpation and visualization) across all risk categories in the general pediatric hospital population.

Design, setting, and participants: An open-label, pragmatic, superiority, randomized clinical trial was conducted in an Australian quaternary pediatric hospital. Children (ages 0-18 years) requiring PIVC insertion were included between July 2021 and December 2022. One catheter was studied per patient, and analysis was by intention to treat. Data analysis was performed from April to October 2023.

Intervention: Eligible children were randomly assigned (1:1 using computer-generated randomization and concealed allocation) to receive ultrasound-guided or standard PIVC insertion. Randomization was stratified by insertion difficulty (low, medium, or high risk) defined using a standardized tool.

Main outcomes and measures: The primary outcome was first-time insertion success. Secondary outcomes included number of insertion attempts, insertion failure, postinsertion complications, dwell time, patient and parent satisfaction, and health care costs.

Results: A total of 164 children were randomly assigned to ultrasound-guided insertion (n = 84) or standard care (n = 80), with 81 (96.4%) and 78 (97.5%) receiving their allocated intervention, respectively. The median (IQR) age was 24 (10-120) months, and 93 children (56.7%) were male. First-time insertion success was higher with ultrasound-guided PIVC insertion (72 children [85.7%]) compared with standard technique (26 children [32.5%]) (risk difference [RD], 53.6%; 95% CI, 41.7%-65.4%; P < .001). Ultrasound-guided insertion led to significantly greater first-time insertion success across all risk categories, with the following RDs: low risk, 30.8% (95% CI, 8.1%-53.5%); medium risk, 56.2% (95% CI, 37.1%-75.3%); and high risk, 69.6% (95% CI, 52.3%-87.0%). Ultrasound-guided PIVC insertion had higher immediate health care costs (between group difference in total mean cost per person, A$9.33; 95% credible interval, A$8.83-A$10.86 [US $5.83; 95% credible interval, $5.52-$6.78]).

Conclusion and relevance: These findings suggest that ultrasound-guided PIVC insertion improves first-time insertion success across all risk categories in pediatrics, supporting the widespread adoption of ultrasound-guided PIVC insertion in children.

Trial registration: anzctr.org.au Identifier: ACTRN12621000206820.