ChildNCT02312388
Comparison of the Central Venous Catheter Insertion Techniques
A study testing catheter-over-the-needle technique and Thin-wall needle technique in people with Child and Surgery, 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 thin-wall needle technique and catheter-over-the-needle technique for central venous catheterization in children. Read more about this study
- Who is it for?
- Ages Up to 5 years
- What is being tested?
- catheter-over-the-needle technique and Thin-wall needle technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to May 2014
- 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
- require central venous catheterization
Who cannot join
- hematoma in central vein
- central vein anomaly
- catheterization site infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Central Venous Catheter Insertion Techniques: the Thin-wall Needle Versus the Catheter-over-the-needle Technique in Children
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between thin-wall needle technique and catheter-over-the-needle technique for central venous catheterization in children.
Read the detailed description
Catheterization was performed using ultrasound with an "out-of-plane" approach by inserting the introducer needle (thin-wall needle technique) or Angiocath Plus™ catheter (catheter-over-the-needle technique) in 45 - 60° to the patient's skin while viewing the vein in a cross section.
- Being tested
- catheter-over-the-needle technique, Thin-wall needle technique
- Keywords
- central venous catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter-over-the-needle techniqueOther
Also called modified Seldinger technique
using a 22 G Angiocath Plus™ catheter
Thin-wall needle techniqueOther
Also called Seldinger technique
using 18 - 21 G introducer needle
| Study group | Role | What they receive |
|---|---|---|
| Catheter-over-the-needle technique | Experimental | to use the 22G angiocatheter for central venous catheterization Receives: Other: catheter-over-the-needle technique |
| Thin-wall needle technique | Experimental | to use the sharp hollow 23G needle for central venous catheterization Receives: Other: Thin-wall needle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guide-wire insertion time
Measured: interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds
Secondary outcomes (4)
Time to first puncture of central vein
Measured: interval between skin penetration of the needle or catheter and flashback of blood, an expected average of 25 seconds
Total time of central venous catheter insertion
Measured: interval between skin penetration of the needle or catheter 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 25 seconds
Number of guide-wire insertion trial
Measured: up to 5 times, an expected average observation time of 80 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies 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
- 138 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
- NCT02312388
- Sponsor's protocol ID
- H-1303-113-478
- Status last verified
- Dec 2014
- First submitted
- 27 Nov 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Central Venous Catheter Insertion Techniques: the Thin-wall Needle Versus the Catheter-over-the-needle Technique in Children
- ClinicalTrials.gov ID
- NCT02312388
- Acronym / sponsor ID
- H-1303-113-478
- Keywords
- central venous catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Dec 2014 (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 thin-wall needle technique and catheter-over-the-needle technique for central venous catheterization in children.
Detailed description
Catheterization was performed using ultrasound with an "out-of-plane" approach by inserting the introducer needle (thin-wall needle technique) or Angiocath Plus™ catheter (catheter-over-the-needle technique) in 45 - 60° to the patient's skin while viewing the vein in a cross section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-over-the-needle technique | Experimental | Other: catheter-over-the-needle techniqueto use the 22G angiocatheter for central venous catheterization |
| Thin-wall needle technique | Experimental | Other: Thin-wall needle techniqueto use the sharp hollow 23G needle for central venous catheterization |
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
- require central venous catheterization
Key exclusion criteria (3 listed)
- hematoma in central vein
- central vein anomaly
- 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 |
|---|---|---|
| catheter-over-the-needle techniqueAlso: modified Seldinger techniqueusing a 22 G Angiocath Plus™ catheter | Other | Catheter-over-the-needle technique |
| Thin-wall needle techniqueAlso: Seldinger techniqueusing 18 - 21 G introducer needle | Other | Thin-wall needle technique |
Primary outcome
Guide-wire insertion time
Time frame: interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds
4 secondary outcomes
Time to first puncture of central vein
Time frame: interval between skin penetration of the needle or catheter and flashback of blood, an expected average of 25 seconds
Total time of central venous catheter insertion
Time frame: interval between skin penetration of the needle or catheter 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 25 seconds
Number of guide-wire insertion trial
Time frame: up to 5 times, an expected average observation time of 80 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 Dec 2014.
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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 catheter-over-the-needle technique and Thin-wall needle technique in people with Child and Surgery, 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 Dec 2014. 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?
Guide-wire insertion time (time frame: interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014.