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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Need for central venous catheter per surgical team

Coagulopathy

History of severe thrombosis

Other investigator-determined ineligibility

Trial design

Design model

Parallel

Treatments tested in this trial

  • Midline catheter placement via basilic vein

    Procedure/Surgery

    Midline catheter placement via basilic vein under ultrasound guidance

  • Midline catheter placement via cephalic vein

    Procedure/Surgery

    Midline catheter placement via cephalic vein under ultrasound guidance

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Basilic Vein GroupActive comparator 1 intervention
Group B: Cephalic Vein GroupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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