Study on Complications After Midline Catheter Placement and the Risk Factors in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with Complications Related to Midline Catheter
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
midline catheter inserted group
干预措施: midline catheter insertion during general anesthesia (Device)
结局指标
主要结局
Number of Participants with Complications Related to Midline Catheter
时间窗: 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.
次要结局
- 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))
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital