Complications of Midline Catheter in Surgical Children

NCT06979167 | Completed

• 1 other identifier: 2503-174-1626
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to understand the incidence and risk factors of complications associated with midline catheter placement in pediatric patients (under 18 years old) undergoing general anesthesia. The main questions it aims to answer are: What is the overall complication rate (including malfunction, bleeding, thrombosis, inflammation, and infection) after midline catheter placement in children? What factors (e.g., age, weight, vein diameter, insertion site, catheter maintenance duration) are associated with a higher risk of complications? Participants will: Receive a midline catheter during surgery under general anesthesia. Undergo ultrasound-guided assessment of the catheter site immediately after placement, 24 hours later, and before the catheter is removed. Be monitored for any complications related to the catheter, including infection, blood clots, or blockage. This study will help identify which factors increase the risk of complications, improving the safe use of midline catheters in pediatric patients.

Conditions

Midline Catheter

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Complications Related to Midline Catheter

  The overall complication rate is defined as the proportion of patients experiencing any catheter-related complications, including catheter malfunction, infection (clinical signs or positive culture), bleeding at the insertion site, thrombosis (confirmed by ultrasound), and catheter dislodgement.

  From midline catheter insertion to catheter removal (up to 7 days).

Secondary Outcomes (5)

• Number of Participants with Each Type of Complication

  From midline catheter insertion to catheter removal (up to 7 days).

• Midline Catheter Maintenance Duration

  From midline catheter insertion to catheter removal (up to 7 days).

• Number of Participants with Premature Catheter Removal and Reasons

  From midline catheter insertion to catheter removal (up to 7 days).

• Number of Participants with Thrombosis Confirmed by Ultrasound

  From midline catheter insertion to catheter removal (up to 7 days)

• Number of participants receiving treatment for Complications

  From midline catheter insertion to catheter removal (up to 7 days)

Study Arms (1)

midline catheter inserted group

Device: midline catheter insertion during general anesthesia

Interventions

midline catheter insertion during general anesthesia DEVICE

This intervention involves the ultrasound-guided insertion of a midline catheter into a peripheral vein (basilic, cephalic, or brachial vein) during general anesthesia in pediatric patients.

midline catheter inserted group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include pediatric patients under 18 years of age who are undergoing general anesthesia for surgery at Seoul National University Hospital and require midline catheter placement. This population is selected to investigate the incidence and risk factors for complications associated with midline catheter insertion in pediatric patients.

You may qualify if:

• Pediatric patients under 18 years of age
• Scheduled to undergo general anesthesia for surgery at Seoul National University Children's Hospital.
• Clinically indicated for midline catheter insertion as determined by the attending anesthesiologist.

You may not qualify if:

• Patients requiring central venous catheter (CVC) insertion instead of a midline catheter.
• Known coagulation disorders.
• History of severe thrombosis.
• Any other conditions that, in the investigator's judgment, make the patient unsuitable for the study.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 03080, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: April 21, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 30, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

KR (1)