UltrasoundNCT02333786
Ultrasound-guided Arterial Catheterization in Pediatric Patients
A study testing Long-axis/in-plane US-guided arterial catheterization and Short-axis/out-of-plane US-guided arterial catheterization in people with Ultrasound and Arterial Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Ultrasound, Arterial Catheterization, Child
- What is being tested?
- Long-axis/in-plane US-guided arterial catheterization and Short-axis/out-of-plane US-guided arterial catheterization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to May 2015
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgery under general anesthesia
- Requires invasive arterial blood pressure monitoring
Who cannot join
- Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
- Peripheral vascular disease
- Congenital aortic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.
- Conditions
- Ultrasound, Arterial Catheterization, Child
- Being tested
- Long-axis/in-plane US-guided arterial catheterization, Short-axis/out-of-plane US-guided arterial catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-axis/in-plane US-guided arterial catheterizationOther
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.
Short-axis/out-of-plane US-guided arterial catheterizationOther
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.
| Study group | Role | What they receive |
|---|---|---|
| Infant | Experimental | Radial artery or posterior tibial artery of patients younger than 1 year old are either cannulated with short-axis/out-of-plane or long-axis/in-plane US-guided arterial catheterization technique. Receives: Other: Long-axis/in-plane US-guided arterial catheterization; Other: Short-axis/out-of-plane US-guided arterial catheterization |
| Preschool child | Experimental | Radial artery or posterior tibial artery of patients older than 1 year old and younger than 5 years old are either cannulated with long-axis/in-plane or short-axis/out-of-plane US-guided arterial catheterization technique. Receives: Other: Long-axis/in-plane US-guided arterial catheterization; Other: Short-axis/out-of-plane US-guided arterial catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial catheterization time
Measured: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds
Secondary outcomes (3)
Ultrasound imaging time
Measured: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds
Time to first puncture of the artery
Measured: Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds
Number of puncture attempts
Measured: Up to 5 times, an expected average observation time of 600 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD. PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333786
- Sponsor's protocol ID
- H-1409-095-610
- Status last verified
- Oct 2015
- First submitted
- 5 Jan 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453.
PubMed 26986774
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02333786
- Acronym / sponsor ID
- H-1409-095-610
- Conditions
- Ultrasound, Arterial Catheterization, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jan 2015 (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.
Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant | Experimental | Other: Long-axis/in-plane US-guided arterial catheterization, Other: Short-axis/out-of-plane US-guided arterial catheterizationRadial artery or posterior tibial artery of patients younger than 1 year old are either cannulated with short-axis/out-of-plane or long-axis/in-plane US-guided arterial catheterization technique. |
| Preschool child | Experimental | Other: Long-axis/in-plane US-guided arterial catheterization, Other: Short-axis/out-of-plane US-guided arterial catheterizationRadial artery or posterior tibial artery of patients older than 1 year old and younger than 5 years old are either cannulated with long-axis/in-plane or short-axis/out-of-plane US-guided arterial catheterization technique. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Surgery under general anesthesia
- Requires invasive arterial blood pressure monitoring
Key exclusion criteria (3 listed)
- Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
- Peripheral vascular disease
- Congenital aortic disease
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 |
|---|---|---|
| Long-axis/in-plane US-guided arterial catheterizationCannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer. | Other | Infant, Preschool child |
| Short-axis/out-of-plane US-guided arterial catheterizationCannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer. | Other | Infant, Preschool child |
Primary outcome
Arterial catheterization time
Time frame: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds
3 secondary outcomes
Ultrasound imaging time
Time frame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds
Time to first puncture of the artery
Time frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds
Number of puncture attempts
Time frame: Up to 5 times, an expected average observation time of 600 seconds
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 7 Oct 2015.
- Derived from this study: PubMed 26986774Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453.
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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.
Jin-Tae Kim, MD. PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-axis/in-plane US-guided arterial catheterization and Short-axis/out-of-plane US-guided arterial catheterization in people with Ultrasound and 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 2 inclusion and 3 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 7 Oct 2015. 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?
Arterial catheterization time (time frame: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333786, which also lists 1 linked publication.
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 7 Oct 2015.