Vascular Access Device Complications
Conditions
Brief summary
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.
Interventions
PROCEDUREMidline catheter placement via basilic vein
Midline catheter placement via basilic vein under ultrasound guidance
PROCEDUREMidline catheter placement via cephalic vein
Midline catheter placement via cephalic vein under ultrasound guidance
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical blood sampling success rate during catheter dwell period | From catheter insertion until catheter removal (up to 7 days postoperatively) | 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
| Measure | Time frame | Description |
|---|---|---|
| Operator-rated difficulty score | At time of catheter insertion | Operator-rated difficulty of midline catheterization assessed on a numerical rating scale (0-10; 0=very easy, 10=extremely difficult) |
| Number of puncture attempts | At time of catheter insertion | Total number of needle puncture attempts required for successful midline catheter placement |
| First attempt cannulation success rate | At time of catheter insertion | Proportion of participants in whom the midline catheter was successfully placed on the first puncture attempt (%) |
| Standardized blood aspiration success | Intraoperatively and postoperative day 1 | Success of blood aspiration through the midline catheter using a standardized protocol (≥2 mL), assessed intraoperatively and on postoperative day 1 |
| Allocated vein diameter and depth | At time of catheter insertion | Diameter (mm) and depth (mm) of the allocated vein (basilic or cephalic) measured by ultrasound before and after catheter placement |
| Catheter dwell time | From catheter insertion until catheter removal (up to 7 days postoperatively) | Duration from catheter insertion to catheter removal (days) |
| Catheter-related complications | From catheter insertion until catheter removal (up to 7 days postoperatively) | Incidence of catheter-related complications including hematoma, bleeding, infection, and thrombosis |
| Patient satisfaction score | At catheter removal (up to 7 days postoperatively) | Patient or caregiver satisfaction with the midline catheter assessed on a numerical rating scale (0-10; 0=very dissatisfied, 10=very satisfied) |
Countries
South Korea
Contacts
CONTACTJung-Bin Park, MDPhD
Outcome results
None listed