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RecruitingNCT07509359Updated Apr 3, 2026

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

An interventional study of Midline catheter placement via basilic vein and Midline catheter placement via cephalic vein in Vascular Access Device Complications, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
2 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Access Device Complications
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Need for central venous catheter per surgical team
  • Coagulopathy
  • History of severe thrombosis
  • Other investigator-determined ineligibility
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Active comparator
    Basilic Vein Group

    Procedure: Midline catheter placement via basilic vein

  • Experimental
    Cephalic Vein Group

    Procedure: Midline catheter placement via cephalic vein

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

06

What researchers measure

Primary outcomes

  1. 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 (%)

    Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)

Secondary outcomes

  1. 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

  2. Number of puncture attempts

    Total number of needle puncture attempts required for successful midline catheter placement

    Time frame: At time of catheter insertion

  3. 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

  4. 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

  5. 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

  6. Catheter dwell time

    Duration from catheter insertion to catheter removal (days)

    Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)

  7. 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)

  8. 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)

07

Study locations

1 of 1 sites recruiting
  • Hee-Soo Kim
    Seoul, Soul-t'ukpyolsi 03080, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07509359
Lead sponsor
Seoul National University Hospital
Responsible party
Hee-Soo Kim (professor, Seoul National University Hospital) — Principal investigator
First posted
Apr 3, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 8, 2026 (estimated)
Completion
Apr 1, 2030 (estimated)
Last update
Apr 3, 2026

Study contacts

Jung-Bin Park, MDPhD
Contact
psb3237@naver.com
220723664 ext. 82

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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