Arterial LineNCT03217019
Guidewire-assisted Radial A-line in Neonate and Infant
A study testing Guidewire-assist and Direct in people with Arterial Line, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter. The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr). Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Arterial Line
- What is being tested?
- Guidewire-assist and Direct
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2017to 4 Jul 2018
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)
Who cannot join
- Skin lesion, infection, hematoma, recent cannulation at cannulation site
- Unstable radial pulse (d/t unstable vital sign, or arrhythmias)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted
In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.
The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).
- Conditions
- Arterial Line
- Being tested
- Guidewire-assist, Direct
- Keywords
- Radial Artery, Vascular Catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidewire-assistProcedure or surgery
catheter insertion with guidewire-assist(catheter over guidewire)
DirectProcedure or surgery
catheter insertion without guidewire assist(catheter over needle)
| Study group | Role | What they receive |
|---|---|---|
| Guidewire | Experimental | 1. Radial artery puncture with direct radial pulse palpation.
2. 24G angiocatheter insertion with guidewire-assist. (Catheter over guidewire) Receives: Procedure: Guidewire-assist |
| Direct | Active comparator | 1. Radial artery puncture with direct radial pulse palpation.
2. 24G angiocatheter insertion without guidewire-assist. (Catheter over needle) Receives: Procedure: Direct |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate at 1st attempt (%)
successful catheter insertion after obtaining 1st blood flush in angiocatheter.
Measured: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary outcomes (5)
total elapsed time (seconds)
total time for successful cannulation.
Measured: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total cannulation attempts (number)
number of total attempts until successful cannulation. (1 attempt = 1 blood flush)
Measured: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total catheter used (number)
number of total catheter used until successful cannulation.
Measured: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
malfunction of arterial line
pressure monitoring, blood sampling
Measured: from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
complications
hematoma, ischemia
Measured: from the arterial cannulation until the end of anesthesia (up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start7 Aug 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
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 Arterial LineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 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, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217019
- Sponsor's protocol ID
- 1706-086-859
- Status last verified
- Apr 2019
- First submitted
- 10 Jul 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.
PubMed 31356376
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted
- ClinicalTrials.gov ID
- NCT03217019
- Acronym / sponsor ID
- 1706-086-859
- Conditions
- Arterial Line
- Keywords
- Radial Artery, Vascular Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 13 Jul 2017 (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.
In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.
The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(<1yr).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidewire | Experimental | Procedure: Guidewire-assist1. Radial artery puncture with direct radial pulse palpation. 2. 24G angiocatheter insertion with guidewire-assist. (Catheter over guidewire) |
| Direct | Active comparator | Procedure: Direct1. Radial artery puncture with direct radial pulse palpation. 2. 24G angiocatheter insertion without guidewire-assist. (Catheter over needle) |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)
Key exclusion criteria (2 listed)
- Skin lesion, infection, hematoma, recent cannulation at cannulation site
- Unstable radial pulse (d/t unstable vital sign, or arrhythmias)
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 |
|---|---|---|
| Guidewire-assistcatheter insertion with guidewire-assist(catheter over guidewire) | Procedure or surgery | Guidewire |
| Directcatheter insertion without guidewire assist(catheter over needle) | Procedure or surgery | Direct |
Primary outcome
success rate at 1st attempt (%)
Time frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
successful catheter insertion after obtaining 1st blood flush in angiocatheter.
5 secondary outcomes
total elapsed time (seconds)
Time frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total cannulation attempts (number)
Time frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
number of total catheter used (number)
Time frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
malfunction of arterial line
Time frame: from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
complications
Time frame: from the arterial cannulation until the end of anesthesia (up to 1 day)
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 8 Apr 2019.
- Derived from this study: PubMed 31356376Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.
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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 study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidewire-assist and Direct in people with Arterial Line, 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 2 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 8 Apr 2019. 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?
success rate at 1st attempt (%) (time frame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)). 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 NCT03217019, 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 8 Apr 2019.