Catheterization, Central VenousNCT03530618
Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children
A study testing Flexible tip straight guidewire and J-tip in people with Catheterization, Central Venous, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Flexible tip straight guidewire and J-tip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Sep 2018to 1 Jul 2021
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- surgery under general anesthesia
- require central venous catheterization
Who cannot join
- central vein anomaly
- hematoma in central vein
- catheterization site infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.
- Conditions
- Catheterization, Central Venous
- Being tested
- Flexible tip straight guidewire, J-tip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible tip straight guidewireDevice
Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization
J-tipDevice
Use a J tip straight guidewire for ultrasound-guided central venous catheterization
| Study group | Role | What they receive |
|---|---|---|
| Flexible tip straight guidewire | Experimental | Not described Receives: Device: Flexible tip straight guidewire |
| J-tip guidewire | Experimental | Not described Receives: Device: J-tip |
What is being measured
The primary outcome is the main question the study is designed to answer.
First successful central venous catheterization rate
Measured: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
Secondary outcomes (7)
Time to first puncture of central vein
Measured: Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
Time to guide wire insertion
Measured: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
Total time to central venous catheterization
Measured: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
Number of central vein puncture trial
Measured: up to 5 times, an expected average observation time of 30 seconds
Number of guide wire insertion trial
Measured: up to 5 times, an expected average observation time of 90 seconds
First successful central vein puncture rate
Measured: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
First successful guide wire insertion rate
Measured: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start6 Sep 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
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 Catheterization, Central VenousStudies 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
- None (open label)
- Enrolment
- 88 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, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530618
- Sponsor's protocol ID
- H-1803-150-935
- Status last verified
- Sep 2021
- First submitted
- 8 May 2018
- Last updated
- 20 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim EH, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Straight-tip guidewire versus J-tip guidewire for central venous catheterisation in neonates and small infants: A randomised controlled trial. Eur J Anaesthesiol. 2022 Aug 1;39(8):656-661. doi: 10.1097/EJA.0000000000001695. Epub 2022 Jul 7.
PubMed 35793466
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03530618
- Acronym / sponsor ID
- H-1803-150-935
- Conditions
- Catheterization, Central Venous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 21 May 2018 (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.
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible tip straight guidewire | Experimental | Device: Flexible tip straight guidewire |
| J-tip guidewire | Experimental | Device: J-tip |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- surgery under general anesthesia
- require central venous catheterization
Key exclusion criteria (3 listed)
- central vein anomaly
- hematoma in central vein
- catheterization site infection
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 |
|---|---|---|
| Flexible tip straight guidewireUse a flexible tip straight guidewire for ultrasound-guided central venous catheterization | Device | Flexible tip straight guidewire |
| J-tipUse a J tip straight guidewire for ultrasound-guided central venous catheterization | Device | J-tip guidewire |
Primary outcome
First successful central venous catheterization rate
Time frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
7 secondary outcomes
Time to first puncture of central vein
Time frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
Time to guide wire insertion
Time frame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
Total time to central venous catheterization
Time frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
Number of central vein puncture trial
Time frame: up to 5 times, an expected average observation time of 30 seconds
Number of guide wire insertion trial
Time frame: up to 5 times, an expected average observation time of 90 seconds
First successful central vein puncture rate
Time frame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
First successful guide wire insertion rate
Time frame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 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 20 Sep 2021.
- Derived from this study: PubMed 35793466Kim EH, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Straight-tip guidewire versus J-tip guidewire for central venous catheterisation in neonates and small infants: A randomised controlled trial. Eur J Anaesthesiol. 2022 Aug 1;39(8):656-661. doi: 10.1097/EJA.0000000000001695. Epub 2022 Jul 7.
- Individual participant dataSharing planned: Undecided
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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, Professor 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 Flexible tip straight guidewire and J-tip in people with Catheterization, Central Venous, 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 20 Sep 2021. 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 successful central venous catheterization rate (time frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes). 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 NCT03530618, 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 20 Sep 2021.