Vascular Access Device ComplicationsNCT07509359
Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children
A study testing Midline catheter placement via basilic vein and Midline catheter placement via cephalic vein in people with Vascular Access Device Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective randomized controlled trial aims to compare basilic vein and cephalic vein approaches for midline catheter placement in pediatric patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Device Complications
- What is being tested?
- Midline catheter placement via basilic vein and Midline catheter placement via cephalic vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 2-17 years undergoing general anesthesia
- Midline catheter placement deemed necessary by attending anesthesiologist (≥1 of: expected ≥2 postop blood draws; expected blood loss ≥40% EBV; continuous antibiotic therapy; hospitalization ≥7 days; surgical team request)
Who cannot join
- Need for central venous catheter per surgical team
- Coagulopathy
- History of severe thrombosis
- Other investigator-determined ineligibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, 03080
Hee-Soo Kim, MD.PhD, 08201052878006, dami0605@snu.ac.kr
Eun-Hee Kim, MD., 08201099335014, beloveun@gmail.com
About this study
Official title: Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children: A Randomized Controlled Trial
This prospective randomized controlled trial aims to compare basilic vein and cephalic vein approaches for midline catheter placement in pediatric patients undergoing general anesthesia. Participants aged 2 to 17 years who require midline catheter insertion will be randomly assigned 1:1 to either the basilic vein group or the cephalic vein group. The primary outcome is the clinical blood sampling success rate during the catheter dwell period, defined as successful aspiration of ≥2 mL of blood through the midline catheter at least once without additional venipuncture. Secondary outcomes include operator-rated difficulty, number of puncture attempts, first attempt cannulation success rate, vein diameter and depth, catheter dwell time, catheter-related complications, and patient satisfaction. A total of 96 participants (48 per arm) will be enrolled at Seoul National University Children's Hospital.
- Conditions
- Vascular Access Device Complications
- Being tested
- Midline catheter placement via basilic vein, Midline catheter placement via cephalic vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline catheter placement via basilic veinProcedure or surgery
Midline catheter placement via basilic vein under ultrasound guidance
Midline catheter placement via cephalic veinProcedure or surgery
Midline catheter placement via cephalic vein under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Basilic Vein Group | Active comparator | Not described Receives: Procedure: Midline catheter placement via basilic vein |
| Cephalic Vein Group | Experimental | Not described Receives: Procedure: Midline catheter placement via cephalic vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical blood sampling success rate during catheter dwell period
Clinical blood sampling success rate during catheter dwell period - defined as successful aspiration of ≥2 mL of blood through the midline catheter for clinically indicated laboratory testing at least once during the dwell period, without additional venipuncture (%)
Measured: From catheter insertion until catheter removal (up to 7 days postoperatively)
Secondary outcomes (8)
Operator-rated difficulty score
Operator-rated difficulty of midline catheterization assessed on a numerical rating scale (0-10; 0=very easy, 10=extremely difficult)
Measured: At time of catheter insertion
Number of puncture attempts
Total number of needle puncture attempts required for successful midline catheter placement
Measured: At time of catheter insertion
First attempt cannulation success rate
Proportion of participants in whom the midline catheter was successfully placed on the first puncture attempt (%)
Measured: At time of catheter insertion
Standardized blood aspiration success
Success of blood aspiration through the midline catheter using a standardized protocol (≥2 mL), assessed intraoperatively and on postoperative day 1
Measured: Intraoperatively and postoperative day 1
Allocated vein diameter and depth
Diameter (mm) and depth (mm) of the allocated vein (basilic or cephalic) measured by ultrasound before and after catheter placement
Measured: At time of catheter insertion
Catheter dwell time
Duration from catheter insertion to catheter removal (days)
Measured: From catheter insertion until catheter removal (up to 7 days postoperatively)
Catheter-related complications
Incidence of catheter-related complications including hematoma, bleeding, infection, and thrombosis
Measured: From catheter insertion until catheter removal (up to 7 days postoperatively)
Patient satisfaction score
Patient or caregiver satisfaction with the midline catheter assessed on a numerical rating scale (0-10; 0=very dissatisfied, 10=very satisfied)
Measured: At catheter removal (up to 7 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion8 Apr 2026 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access Device ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
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
- NCT07509359
- Sponsor's protocol ID
- 2602-130-1721
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Basilic and Cephalic Vein Approaches for Midline Catheter Placement in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07509359
- Acronym / sponsor ID
- 2602-130-1721
- Conditions
- Vascular Access Device Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 8 Apr 2026 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 3 Apr 2026 (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.
This prospective randomized controlled trial aims to compare basilic vein and cephalic vein approaches for midline catheter placement in pediatric patients undergoing general anesthesia. Participants aged 2 to 17 years who require midline catheter insertion will be randomly assigned 1:1 to either the basilic vein group or the cephalic vein group. The primary outcome is the clinical blood sampling success rate during the catheter dwell period, defined as successful aspiration of ≥2 mL of blood through the midline catheter at least once without additional venipuncture. Secondary outcomes include operator-rated difficulty, number of puncture attempts, first attempt cannulation success rate, vein diameter and depth, catheter dwell time, catheter-related complications, and patient satisfaction. A total of 96 participants (48 per arm) will be enrolled at Seoul National University Children's Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basilic Vein Group | Active comparator | Procedure: Midline catheter placement via basilic vein |
| Cephalic Vein Group | Experimental | Procedure: Midline catheter placement via cephalic vein |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 2-17 years undergoing general anesthesia
- Midline catheter placement deemed necessary by attending anesthesiologist (≥1 of: expected ≥2 postop blood draws; expected blood loss ≥40% EBV; continuous antibiotic therapy; hospitalization ≥7 days; surgical team request)
Key exclusion criteria (4 listed)
- Need for central venous catheter per surgical team
- Coagulopathy
- History of severe thrombosis
- Other investigator-determined ineligibility
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 placement via basilic veinMidline catheter placement via basilic vein under ultrasound guidance | Procedure or surgery | Basilic Vein Group |
| Midline catheter placement via cephalic veinMidline catheter placement via cephalic vein under ultrasound guidance | Procedure or surgery | Cephalic Vein Group |
Primary outcome
Clinical blood sampling success rate during catheter dwell period
Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)
Clinical blood sampling success rate during catheter dwell period - defined as successful aspiration of ≥2 mL of blood through the midline catheter for clinically indicated laboratory testing at least once during the dwell period, without additional venipuncture (%)
8 secondary outcomes
Operator-rated difficulty score
Time frame: At time of catheter insertion
Number of puncture attempts
Time frame: At time of catheter insertion
First attempt cannulation success rate
Time frame: At time of catheter insertion
Standardized blood aspiration success
Time frame: Intraoperatively and postoperative day 1
Allocated vein diameter and depth
Time frame: At time of catheter insertion
Catheter dwell time
Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)
Catheter-related complications
Time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)
Patient satisfaction score
Time frame: At catheter removal (up to 7 days postoperatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline catheter placement via basilic vein and Midline catheter placement via cephalic vein in people with Vascular Access Device Complications, 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 2 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: looking for participants now, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Bin Park, MDPhD (220723664 ext. 82, psb3237@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical blood sampling success rate during catheter dwell period (time frame: From catheter insertion until catheter removal (up to 7 days postoperatively)). 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 3 Apr 2026.