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Recruiting NCT07509359

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

No phase Interventional Vascular Access Device Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midline catheter placement via basilic vein, Midline catheter placement via cephalic vein.
Who it may be relevant to
Registry conditions: Vascular Access Device Complications. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children: A Randomized Controlled Trial

Overview

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

  • Procedure Midline catheter placement via basilic vein
    Midline catheter placement via basilic vein under ultrasound guidance
  • Procedure Midline catheter placement via cephalic vein
    Midline catheter placement via cephalic vein under ultrasound guidance

Primary outcome measures

  • Clinical blood sampling success rate during catheter dwell period [Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)]
Secondary outcome measures (8)
  • Operator-rated difficulty score [Time frame: At time of catheter insertion]
  • Number of puncture attempts [Time frame: At time of catheter insertion]
  • First attempt cannulation success rate [Time frame: At time of catheter insertion]
  • Standardized blood aspiration success [Time frame: Intraoperatively and postoperative day 1]
  • Allocated vein diameter and depth [Time frame: At time of catheter insertion]
  • Catheter dwell time [Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)]
  • Catheter-related complications [Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)]
  • Patient satisfaction score [Time frame: At catheter removal (up to 7 days postoperatively)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Hee-Soo Kim — Seoul

Identifiers

NCT: NCT07509359 · 2602-130-1721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗