About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Need for central venous catheter per surgical team
Coagulopathy
History of severe thrombosis
Other investigator-determined ineligibility
Trial design
Parallel
Treatments tested in this trial
Midline catheter placement via basilic vein
Procedure/SurgeryMidline catheter placement via basilic vein under ultrasound guidance
Midline catheter placement via cephalic vein
Procedure/SurgeryMidline catheter placement via cephalic vein under ultrasound guidance
Treatment groups
Trial outcomes
Primary outcomes
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 (%)
Secondary outcomes
Operator-rated difficulty score
Operator-rated difficulty of midline catheterization assessed on a numerical rating scale (0-10; 0=very easy, 10=extremely difficult)
Number of puncture attempts
Total number of needle puncture attempts required for successful midline catheter placement
First attempt cannulation success rate
Proportion of participants in whom the midline catheter was successfully placed on the first puncture attempt (%)
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
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