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Completed

NCT Number: NCT06979167

Complications of Midline Catheter in Surgical Children

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.

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Key information

Conditions

Midline Catheter

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Children's Hospital

Seoul, 03080, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midline catheter insertion during general anesthesia

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.

Primary outcomes

  1. 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

  1. Number of Participants with Each Type of Complication

    Time frame: From midline catheter insertion to catheter removal (up to 7 days).

    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)

  2. Midline Catheter Maintenance Duration

    Time frame: From midline catheter insertion to catheter removal (up to 7 days).

    The total duration (in days) that each patient maintains a functional midline catheter without premature removal.

  3. Number of Participants with Premature Catheter Removal and Reasons

    Time frame: From midline catheter insertion to catheter removal (up to 7 days).

    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)

  4. Number of Participants with Thrombosis Confirmed by Ultrasound

    Time frame: From midline catheter insertion to catheter removal (up to 7 days)

    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.

  5. Number of participants receiving treatment for Complications

    Time frame: From midline catheter insertion to catheter removal (up to 7 days)

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Study on Complications After Midline Catheter Placement and the Risk Factors in Children

Acronym: MIDline

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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