Arterial CatheterizationNCT02912481
Posterior Tibial Artery Catheterization
A study testing posterior tibial artery, radial artery and dorsalis pedis artery in people with Arterial Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Arterial Catheterization
- What is being tested?
- posterior tibial artery, radial artery and dorsalis pedis artery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Jul 2017
- Phase
- Interventional
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing general anesthesia needing invasive arterial monitoring
Who cannot join
- Surgery involving the both hands or foots
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Ultrasound-guided Arterial Catheterization in Pediatric Patients: Comparison of Success Rate Among the Arteries
Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.
- Conditions
- Arterial Catheterization
- Being tested
- posterior tibial artery, radial artery, dorsalis pedis artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior tibial arteryProcedure or surgery
radial arteryProcedure or surgery
dorsalis pedis arteryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Posterior tibial artery | Experimental | real time ultrasound guided arterial catheterization on the posterior tibial artery Receives: Procedure: posterior tibial artery |
| Radial artery | Active comparator | real time ultrasound guided arterial catheterization on the radial artery Receives: Procedure: radial artery |
| Dorsalis pedis artery | Active comparator | real time ultrasound guided arterial catheterization on the dorsalis pedis artery Receives: Procedure: dorsalis pedis artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
first access success rate
Measured: immediate after anesthetic induction, maximum 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial CatheterizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 275 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
- NCT02912481
- Sponsor's protocol ID
- H-1606-108-771
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Ultrasound-guided Arterial Catheterization in Pediatric Patients: Comparison of Success Rate Among the Arteries
- ClinicalTrials.gov ID
- NCT02912481
- Acronym / sponsor ID
- H-1606-108-771
- Conditions
- Arterial Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- 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.
Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Posterior tibial artery | Experimental | Procedure: posterior tibial arteryreal time ultrasound guided arterial catheterization on the posterior tibial artery |
| Radial artery | Active comparator | Procedure: radial arteryreal time ultrasound guided arterial catheterization on the radial artery |
| Dorsalis pedis artery | Active comparator | Procedure: dorsalis pedis arteryreal time ultrasound guided arterial catheterization on the dorsalis pedis artery |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing general anesthesia needing invasive arterial monitoring
Key exclusion criteria (1 listed)
- Surgery involving the both hands or foots
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 |
|---|---|---|
| posterior tibial artery | Procedure or surgery | Posterior tibial artery |
| radial artery | Procedure or surgery | Radial artery |
| dorsalis pedis artery | Procedure or surgery | Dorsalis pedis artery |
Primary outcome
first access success rate
Time frame: immediate after anesthetic induction, maximum 10 minutes
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 6 Sep 2017.
Related trials for Arterial Catheterization
RecruitingObservational study
Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography
Biofilms, Arterial Catheterization, Peripheral
Not yet recruiting
Direct vs. Seldinger Technique for Ultrasound-Guided Difficult Radial Access in Cardiac Surgery
Cardiac Surgery in Adult Patient, Cardiac Surgery
Active, not recruiting
Non-inferiority of Nurse-performed Versus Interventional Cardiologist-Performed Radial Catheterization in Elective Coronary Angiography: a Single-center, Open-label Randomized Trial.
Arterial Catheterization, Intensive Care Medicine
RecruitingObservational study
China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization
Pulmonary Hypertension, Pulmonary Embolism (Diagnosis)
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?
A study testing posterior tibial artery, radial artery and dorsalis pedis artery in people with Arterial Catheterization, 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 1 inclusion and 1 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 6 Sep 2017. 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?
first access success rate (time frame: immediate after anesthetic induction, maximum 10 minutes). 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 6 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.