Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061034) titled 'A Randomized Controlled Trial of Ultrasound-Guided Forearm Cannulation versus Landmark-Guided Dorsal Hand Cannulation in Pediatric Patients' on April 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - FUJITA HEALTH UNIVERSITY

Condition: Condition - pediatric peripheral intravenous infusion Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Peripheral intravenous catheterization (PIVC) in pediatric patients is a fundamental and routinely performed procedure. However, catheter failure (CF) occurs at a relatively high rate of 34-38%, leading to repeated cannulation attempts and infiltration, which increase the burden on both children and their caregivers and result in inefficient use of medical resources.

Traditionally, cannulation of dorsal hand veins has been the standard approach due to their good visibility. In recent years, however, advances in ultrasound technology have enabled cannulation of forearm veins. Despite this, no studies have directly compared CF rates between dorsal hand cannulation and ultrasound-guided forearm cannulation in pediatric patients, and standardization remains insufficient.

This study aims to optimize pediatric venous access techniques based on scientific evidence and has significant clinical relevance in clarifying their effectiveness and safety. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - In the control group (dorsal hand vein cannulation group), cannulation is performed in the dorsal hand vein using a 24-gauge Surflo Flash catheter (Terumo Corporation) according to standard practice. The insertion site is then secured with Microfoam surgical tape and Cathereeplus, followed by immobilization using an age-appropriate pediatric splint. Interventions/Control_2 - In the intervention group (ultrasound guided forearm vein cannulation group), forearm veins are visualized using a FUJIFILM SonoSite ultrasound system with an L25 ( linear probe, and cannulation is performed using a 22 gauge Surflo Flash catheter (Terumo Corporation). The insertion site is secured with Microfoam surgical tape and Cathereeplus, as in the control group, but no splint is used.

Eligibility: Age-lower limit - 6 months-old = Gender - Male and Female Key inclusion criteria - Patients for whom written informed consent was obtained from a parent or legal guardian after adequate explanation of the study. Pediatric patients aged 6 months to 6 years at the time of enrollment. Patients who require inpatient treatment and are judged to need peripheral intravenous catheter (PIVC) infusion for at least 24 hours. Key exclusion criteria - Patients admitted from departments other than pediatrics. Patients with severe underlying conditions (e.g., cardiac disease, renal disease, or immunodeficiency). Patients receiving intravenous fluids other than lactated Ringer solution with glucose or Soludem No. 2 solution. Patients in whom peripheral intravenous access failed after two attempts. Patients whose catheter was removed within 24 hours after initiation of infusion for medical reasons. Patients deemed inappropriate for inclusion by the principal investigator or co-investigators. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 23 Day Date of IRB - 2026 Year 03 Month 23 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069846

Disclaimer: Curated by HT Syndication.