Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children

Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children: A Randomized Controlled Trial

This prospective randomized controlled trial aims to compare basilic vein and cephalic vein approaches for midline catheter placement in pediatric patients undergoing general anesthesia. Participants aged 2 to 17 years who require midline catheter insertion will be randomly assigned 1:1 to either the basilic vein group or the cephalic vein group. The primary outcome is the clinical blood sampling success rate during the catheter dwell period, defined as successful aspiration of ≥2 mL of blood through the midline catheter at least once without additional venipuncture. Secondary outcomes include operator-rated difficulty, number of puncture attempts, first attempt cannulation success rate, vein diameter and depth, catheter dwell time, catheter-related complications, and patient satisfaction. A total of 96 participants (48 per arm) will be enrolled at Seoul National University Children's Hospital.

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Device Complications
• Intervention / Treatment: Procedure: Midline catheter placement via basilic vein; Procedure: Midline catheter placement via cephalic vein

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Bin Park, MDPhD; Phone Number: 82 220723664; Email: psb3237@naver.com

Study Locations

• South Korea
  • Soul-t'ukpyolsi
    • Seoul, Soul-t'ukpyolsi, South Korea, 03080
      • Recruiting
      • Hee-Soo Kim
      • Contact: Eun-Hee Kim, MD.; Phone Number: 08201099335014; Email: beloveun@gmail.com
      • Contact: Hee-Soo Kim, MD.PhD; Phone Number: 08201052878006; Email: dami0605@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 2-17 years undergoing general anesthesia
• Midline catheter placement deemed necessary by attending anesthesiologist (≥1 of: expected ≥2 postop blood draws; expected blood loss ≥40% EBV; continuous antibiotic therapy; hospitalization ≥7 days; surgical team request)

Exclusion Criteria:

• Need for central venous catheter per surgical team
• Coagulopathy
• History of severe thrombosis
• Other investigator-determined ineligibility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Basilic Vein Group	Procedure: Midline catheter placement via basilic vein; Midline catheter placement via basilic vein under ultrasound guidance
Experimental: Cephalic Vein Group	Procedure: Midline catheter placement via cephalic vein; Midline catheter placement via cephalic vein under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical blood sampling success rate during catheter dwell period	Clinical blood sampling success rate during catheter dwell period - defined as successful aspiration of ≥2 mL of blood through the midline catheter for clinically indicated laboratory testing at least once during the dwell period, without additional venipuncture (%)	From catheter insertion until catheter removal (up to 7 days postoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator-rated difficulty score	Operator-rated difficulty of midline catheterization assessed on a numerical rating scale (0-10; 0=very easy, 10=extremely difficult)	At time of catheter insertion
Number of puncture attempts	Total number of needle puncture attempts required for successful midline catheter placement	At time of catheter insertion
First attempt cannulation success rate	Proportion of participants in whom the midline catheter was successfully placed on the first puncture attempt (%)	At time of catheter insertion
Standardized blood aspiration success	Success of blood aspiration through the midline catheter using a standardized protocol (≥2 mL), assessed intraoperatively and on postoperative day 1	Intraoperatively and postoperative day 1
Allocated vein diameter and depth	Diameter (mm) and depth (mm) of the allocated vein (basilic or cephalic) measured by ultrasound before and after catheter placement	At time of catheter insertion
Catheter dwell time	Duration from catheter insertion to catheter removal (days)	From catheter insertion until catheter removal (up to 7 days postoperatively)
Catheter-related complications	Incidence of catheter-related complications including hematoma, bleeding, infection, and thrombosis	From catheter insertion until catheter removal (up to 7 days postoperatively)
Patient satisfaction score	Patient or caregiver satisfaction with the midline catheter assessed on a numerical rating scale (0-10; 0=very dissatisfied, 10=very satisfied)	At catheter removal (up to 7 days postoperatively)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 8, 2026
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2602-130-1721

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No