Midline CatheterMIDlineNCT06979167
Complications of Midline Catheter in Surgical Children
An observational study of Midline Catheter, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Midline Catheter
- What is being tested?
- midline catheter insertion during general anesthesia
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 03080
About this study
Official title: 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?
Read more
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.
- Conditions
- Midline Catheter
- Being tested
- midline catheter insertion during general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midline catheter insertion during general anesthesiaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| midline catheter inserted group | Not described Receives: Device: midline catheter insertion during general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Complications Related to Midline Catheter
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.
Measured: From midline catheter insertion to catheter removal (up to 7 days).
Secondary outcomes (5)
Number of Participants with Each Type of Complication
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)
Measured: From midline catheter insertion to catheter removal (up to 7 days).
Midline Catheter Maintenance Duration
The total duration (in days) that each patient maintains a functional midline catheter without premature removal.
Measured: From midline catheter insertion to catheter removal (up to 7 days).
Number of Participants with Premature Catheter Removal and Reasons
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)
Measured: From midline catheter insertion to catheter removal (up to 7 days).
Number of Participants with Thrombosis Confirmed by Ultrasound
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.
Measured: From midline catheter insertion to catheter removal (up to 7 days)
Number of participants receiving treatment for Complications
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.
Measured: From midline catheter insertion to catheter removal (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start21 Apr 2025
- Primary completion23 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midline CatheterStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979167
- Sponsor's protocol ID
- 2503-174-1626
- Acronym
- MIDline
- Status last verified
- Apr 2026
- First submitted
- 9 May 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Complications After Midline Catheter Placement and the Risk Factors in Children
- ClinicalTrials.gov ID
- NCT06979167
- Acronym / sponsor ID
- MIDline / 2503-174-1626
- Conditions
- Midline Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| midline catheter inserted group | – | Device: midline catheter insertion during general anesthesia |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midline catheter insertion during general anesthesiaThis 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. | Device | midline catheter inserted group |
Primary outcome
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.
5 secondary outcomes
Number of Participants with Each Type of Complication
Time frame: 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).
Number of Participants with Premature Catheter Removal and Reasons
Time frame: 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)
Number of participants receiving treatment for Complications
Time frame: From midline catheter insertion to catheter removal (up to 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Midline Catheter, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Complications Related to Midline Catheter (time frame: From midline catheter insertion to catheter removal (up to 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.