Complications of Midline Catheter in Surgical Children (MIDline)

April 14, 2026 updated by: Hee-Soo Kim, Seoul National University Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study will include pediatric patients under 18 years of age who are undergoing general anesthesia for surgery at Seoul National University Hospital and require midline catheter placement. This population is selected to investigate the incidence and risk factors for complications associated with midline catheter insertion in pediatric patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
midline catheter inserted group
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From midline catheter insertion to catheter removal (up to 7 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
From midline catheter insertion to catheter removal (up to 7 days).
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.
From midline catheter insertion to catheter removal (up to 7 days).
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)
From midline catheter insertion to catheter removal (up to 7 days).
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.
From midline catheter insertion to catheter removal (up to 7 days)
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.
From midline catheter insertion to catheter removal (up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2503-174-1626

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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