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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
96
Midline catheter placement via basilic vein under ultrasound guidance
Midline catheter placement via cephalic vein under ultrasound guidance
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, South Korea
RECRUITINGClinical 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 (%)
Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)
Operator-rated difficulty score
Operator-rated difficulty of midline catheterization assessed on a numerical rating scale (0-10; 0=very easy, 10=extremely difficult)
Time frame: At time of catheter insertion
Number of puncture attempts
Total number of needle puncture attempts required for successful midline catheter placement
Time frame: 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 (%)
Time frame: 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
Time frame: 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
Time frame: At time of catheter insertion
Catheter dwell time
Duration from catheter insertion to catheter removal (days)
Time frame: 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
Time frame: 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)
Time frame: At catheter removal (up to 7 days postoperatively)
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