Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07509359

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Vascular Access Device Complications

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midline catheter placement via basilic vein

Procedure

Midline catheter placement via basilic vein under ultrasound guidance

Midline catheter placement via cephalic vein

Procedure

Midline catheter placement via cephalic vein under ultrasound guidance

Primary outcomes

  1. Clinical blood sampling success rate during catheter dwell period

    Time frame: 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 outcomes

  1. Operator-rated difficulty score

    Time frame: 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)

  2. Number of puncture attempts

    Time frame: At time of catheter insertion

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

  3. First attempt cannulation success rate

    Time frame: At time of catheter insertion

    Proportion of participants in whom the midline catheter was successfully placed on the first puncture attempt (%)

  4. Standardized blood aspiration success

    Time frame: 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

  5. Allocated vein diameter and depth

    Time frame: 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

  6. Catheter dwell time

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

    Duration from catheter insertion to catheter removal (days)

  7. Catheter-related complications

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

    Incidence of catheter-related complications including hematoma, bleeding, infection, and thrombosis

  8. Patient satisfaction score

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Bin Park, MDPhD

CONTACT

[email protected]

220723664 ext. 82

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2030
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.