Subclavian Venous Catheterization in ChildrenSuCVCNCT01527175
Ultrasound-guided Subclavian Venous Catheterization in Children
A study testing Approach for ultrasound-guided subclavian venous catheterization in people with Subclavian Venous Catheterization in Children, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Subclavian Venous Catheterization in Children
- What is being tested?
- Approach for ultrasound-guided subclavian venous catheterization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Feb 2012
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- central venous lines required patients
- children < 10 yr of age
Who cannot join
- inadequate ultrasound visualization of the subclavian vein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision of Ultrasound-guided Supraclavicular and Infraclavicular Approach for Central Venous Catheterization in Children
The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.
- Being tested
- Approach for ultrasound-guided subclavian venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach for ultrasound-guided subclavian venous catheterizationOther
Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.
| Study group | Role | What they receive |
|---|---|---|
| supraclavicular | Active comparator | supraclavicular: supraclavicular approach for subclavian venous catheterization Receives: Other: Approach for ultrasound-guided subclavian venous catheterization |
| infraclavicular | Placebo comparator | infraclavicular: infraclavicular approach for subclavian venous catheterization Receives: Other: Approach for ultrasound-guided subclavian venous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration for susscessful placement of needle into subclavian vein
The time needed to place needle into the vein (from needle entry into the skin to aspiration of blood with syringe) was measured. When the duration was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis.
Measured: within 20 minutes
Secondary outcomes (1)
The number of attempt for susscessful placement of needle into subclavian vein.
An 'attempt' was defined as each needle advancement to place needl into the vein. When the duration for susscessful placement of needle into subclavian vein was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis.
Measured: within 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
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 Subclavian Venous Catheterization in ChildrenStudies 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
- 98 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527175
- Sponsor's protocol ID
- JNB-KJT-12
- Acronym
- SuCVC
- Status last verified
- Mar 2012
- First submitted
- 28 Jan 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Byon HJ, Lee GW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Comparison between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in children--a randomized trial. Br J Anaesth. 2013 Nov;111(5):788-92. doi: 10.1093/bja/aet202. Epub 2013 Jun 10.
PubMed 23756247
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Ultrasound-guided Supraclavicular and Infraclavicular Approach for Central Venous Catheterization in Children
- ClinicalTrials.gov ID
- NCT01527175
- Acronym / sponsor ID
- SuCVC / JNB-KJT-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- First posted
- 6 Feb 2012 (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 subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraclavicular | Active comparator | Other: Approach for ultrasound-guided subclavian venous catheterizationsupraclavicular: supraclavicular approach for subclavian venous catheterization |
| infraclavicular | Placebo comparator | Other: Approach for ultrasound-guided subclavian venous catheterizationinfraclavicular: infraclavicular approach for subclavian venous catheterization |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- central venous lines required patients
- children < 10 yr of age
Key exclusion criteria (1 listed)
- inadequate ultrasound visualization of the subclavian vein
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 |
|---|---|---|
| Approach for ultrasound-guided subclavian venous catheterizationEach SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach. | Other | infraclavicular, supraclavicular |
Primary outcome
The duration for susscessful placement of needle into subclavian vein
Time frame: within 20 minutes
The time needed to place needle into the vein (from needle entry into the skin to aspiration of blood with syringe) was measured. When the duration was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis.
1 secondary outcome
The number of attempt for susscessful placement of needle into subclavian vein.
Time frame: within 20 minutes
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 2 Apr 2012.
- Derived from this study: PubMed 23756247Byon HJ, Lee GW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Comparison between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in children--a randomized trial. Br J Anaesth. 2013 Nov;111(5):788-92. doi: 10.1093/bja/aet202. Epub 2013 Jun 10.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach for ultrasound-guided subclavian venous catheterization in people with Subclavian Venous Catheterization in Children, 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 1 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 2 Apr 2012. 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. Some participants in this study may receive a placebo. 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?
The duration for susscessful placement of needle into subclavian vein (time frame: within 20 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 NCT01527175, 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 2 Apr 2012.