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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basilic Vein Group | Active Comparator |
| |
| Cephalic Vein Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midline catheter placement via basilic vein | Procedure | Midline catheter placement via basilic vein under ultrasound guidance |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Bin Park, MDPhD | Contact | 220723664 | 82 | psb3237@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hee-Soo Kim | Recruiting | Seoul | Soul-t'ukpyolsi | 03080 | South Korea |
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| Midline catheter placement via cephalic vein | Procedure | Midline catheter placement via cephalic vein under ultrasound guidance |
|
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) |