Study on Complications After Midline Catheter Placement and the Risk Factors in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of Participants with Complications Related to Midline Catheter
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
midline catheter inserted group
Intervention: midline catheter insertion during general anesthesia (Device)
Outcomes
Primary Outcomes
Number of Participants with Complications Related to Midline Catheter
Time Frame: From midline catheter insertion to catheter removal (up to 7 days).
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.
Secondary Outcomes
- 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))
Investigators
Hee-Soo Kim
Professor
Seoul National University Hospital