Catheterization, PeripheralNCT02795468
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
A study testing Radial arterial cannulation in people with Catheterization, Peripheral, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Catheterization, Peripheral
- What is being tested?
- Radial arterial cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to 28 Feb 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation
Who cannot join
- Sign of a skin infection
- Wound near the puncture site
- abnormal circulation of the hand
- any vascular problem at radial or ulnar artery
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.
Read the detailed description
In infants (<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.
- Conditions
- Catheterization, Peripheral
- Being tested
- Radial arterial cannulation
- Keywords
- Peripheral, Arterial, Catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial arterial cannulationProcedure or surgery
Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group
| Study group | Role | What they receive |
|---|---|---|
| Palpation group | Active comparator | The operator will use the pulsation of the radial artery as a guide for the cannulation. Receives: Procedure: Radial arterial cannulation |
| Ultrasound group | Experimental | The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter. Receives: Procedure: Radial arterial cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-pass success rate
Measured: Within 10 min from the start time of arterial cannulation using an angiocath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheterization, PeripheralStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
- Investigators
- Jong Hwan Lee, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795468
- Sponsor's protocol ID
- 2016-03-128-001
- Status last verified
- Apr 2018
- First submitted
- 26 May 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
PubMed 33097369Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.
PubMed 30431501
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
- ClinicalTrials.gov ID
- NCT02795468
- Acronym / sponsor ID
- 2016-03-128-001
- Conditions
- Catheterization, Peripheral
- Keywords
- Peripheral, Arterial, Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 10 Jun 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.
The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.
Detailed description
In infants (<12mo), radial arterial catheterization is sometimes difficult to perform. Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of ultrasound as an adjunct to radial arterial cannulation has considered to be the best practice in adults and pediatrics. However, its usefulness or superiority for neonates and infants is not known. Therefore, we would compare ultrasound guided radial arterial cannulation with the usual palpation methods in infants undergoing cardiac surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation group | Active comparator | Procedure: Radial arterial cannulationThe operator will use the pulsation of the radial artery as a guide for the cannulation. |
| Ultrasound group | Experimental | Procedure: Radial arterial cannulationThe ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation
Key exclusion criteria (4 listed)
- Sign of a skin infection
- Wound near the puncture site
- abnormal circulation of the hand
- any vascular problem at radial or ulnar artery
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 |
|---|---|---|
| Radial arterial cannulationRadial arterial cannulation using usual palpation method or ultrasound guided technique according to the group | Procedure or surgery | Palpation group, Ultrasound group |
Primary outcome
First-pass success rate
Time frame: Within 10 min from the start time of arterial cannulation using an angiocath
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 26 Apr 2018.
- Derived from this study: PubMed 33097369Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.
- Derived from this study: PubMed 30431501Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.
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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.
Jong Hwan Lee principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial arterial cannulation in people with Catheterization, Peripheral, run by Samsung Medical Center 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 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 26 Apr 2018. 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-pass success rate (time frame: Within 10 min from the start time of arterial cannulation using an angiocath). 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 NCT02795468, which also lists 2 linked publications.
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 26 Apr 2018.