Complications of Midline Catheter in Surgical Children

NCT ID: NCT06979167

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-03-04

Brief Summary

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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.

Detailed Description

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Conditions

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Midline Catheter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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midline catheter inserted group

midline catheter insertion during general anesthesia

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Children's Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jung-Bin Park

Role: primary

82-2-2072-3664

Other Identifiers

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2503-174-1626

Identifier Type: -

Identifier Source: org_study_id

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