An observational study in Midline Catheter, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Seoul National University Hospital · Observational
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: From midline catheter insertion to catheter removal (up to 7 days).
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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From midline catheter insertion to catheter removal (up to 7 days)
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital