Catheterization, Central VenousNCT02688595
Central Venous Catheterization Techniques in Neonates
A study testing Ultrasound and General anesthesia 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 Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Ultrasound and General anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Sep 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 1 month
- 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: Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.
- Conditions
- Catheterization, Central Venous
- Being tested
- Ultrasound, General anesthesia
- Keywords
- Infant, Newborn, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound-guided central venous catheterization in internal jugular vein
General anesthesiaOther
Scheduled operation under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Seldinger | Experimental | Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization Receives: Device: Ultrasound; Other: General anesthesia |
| Modified Seldinger | Experimental | Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization Receives: Device: Ultrasound; Other: General anesthesia |
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 or angiocatheter 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 or angiocatheter 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 or angiocatheter after guide wire insertion, an expected average of 90 seconds
Total time to central venous catheterization
Measured: Interval between skin penetration of the needle or angiocatheter 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 or angiocatheter 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 posted23 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688595
- Sponsor's protocol ID
- 1601-108-736
- Status last verified
- Jan 2018
- First submitted
- 17 Feb 2016
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.
PubMed 15121722Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.
PubMed 26248059Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.
PubMed 30442261
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger
- ClinicalTrials.gov ID
- NCT02688595
- Acronym / sponsor ID
- 1601-108-736
- Conditions
- Catheterization, Central Venous
- Keywords
- Infant, Newborn, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Feb 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 purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seldinger | Experimental | Device: Ultrasound, Other: General anesthesiaUse a 23 gauge introducer needle for ultrasound-guided central venous catheterization |
| Modified Seldinger | Experimental | Device: Ultrasound, Other: General anesthesiaUse a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization |
Who may qualify
- Ages
- 1 day to 1 month
- 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 |
|---|---|---|
| UltrasoundUltrasound-guided central venous catheterization in internal jugular vein | Device | Modified Seldinger, Seldinger |
| General anesthesiaScheduled operation under general anesthesia | Other | Modified Seldinger, Seldinger |
Primary outcome
First successful central venous catheterization rate
Time frame: Interval between skin penetration of the needle or angiocatheter 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 or angiocatheter 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 or angiocatheter 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 or angiocatheter 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 or angiocatheter 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 9 Jan 2018.
- Background: PubMed 15121722Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.
- Background: PubMed 26248059Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.
- Derived from this study: PubMed 30442261Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 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 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 Ultrasound and General anesthesia 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 9 Jan 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 successful central venous catheterization rate (time frame: Interval between skin penetration of the needle or angiocatheter 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 NCT02688595, which also lists 3 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 9 Jan 2018.