Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:25 PM
Study NCT ID:
NCT06979167
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications of Midline Catheter in Surgical Children
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Study on Complications After Midline Catheter Placement and the Risk Factors in Children
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIDline
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: