Complications of Midline Catheter in Surgical Children (MIDline)

Study on Complications After Midline Catheter Placement and the Risk Factors in Children

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.

Study Overview

• Status: Completed
• Conditions: Midline Catheter
• Intervention / Treatment: Device: midline catheter insertion during general anesthesia

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
midline catheter inserted group	Device: midline catheter insertion during general anesthesia; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Each Type of Complication	The incidence of each specific complication type will be recorded, including: Catheter malfunction (clinical assessment), Infection (clinical signs or positive culture), Bleeding at the insertion site (visual inspection), Thrombosis (confirmed by ultrasound), Catheter dislodgement (clinical assessment)	From midline catheter insertion to catheter removal (up to 7 days).
Midline Catheter Maintenance Duration	The total duration (in days) that each patient maintains a functional midline catheter without premature removal.	From midline catheter insertion to catheter removal (up to 7 days).
Number of Participants with Premature Catheter Removal and Reasons	The primary reason for catheter removal will be documented, including: Planned removal (completion of clinical need), Premature removal due to complications (infection, malfunction, thrombosis, or patient discomfort)	From midline catheter insertion to catheter removal (up to 7 days).
Number of Participants with Thrombosis Confirmed by Ultrasound	The presence of thrombosis at the catheter site will be assessed using ultrasound. Ultrasound will be performed immediately after insertion, 24 hours later, and at the time of catheter removal. Thrombosis will be defined as the presence of an intraluminal thrombus or significant vein narrowing.	From midline catheter insertion to catheter removal (up to 7 days)
Number of participants receiving treatment for Complications	This outcome measures the frequency and types of treatments administered for complications associated with the midline catheter, including: Antibiotics for infection (based on clinical signs or positive culture).; Anticoagulants for thrombosis (confirmed by ultrasound).; Additional catheter procedures (replacement, adjustment, or removal).; Analgesics or anti-inflammatory medications for local inflammation or pain. Each treatment will be documented, including the type, dose, route, and reason for administration.	From midline catheter insertion to catheter removal (up to 7 days)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Actual): December 23, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 11, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2503-174-1626