Central Venous CatheterizationNCT01003366
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
A study testing bevel direction during central venous catheterization in people with Central Venous Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- bevel direction during central venous catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Feb 2011
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein
Who cannot join
- anatomical anomaly in the neck region
- recent history of central venous catheterization
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.
- Conditions
- Central Venous Catheterization
- Being tested
- bevel direction during central venous catheterization
- Keywords
- safety during central venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevel direction during central venous catheterizationDevice
approaching the IJV with the needle bevel facing down
bevel direction during central venous catheterizationDevice
approaching the IJV with the needle bevel facing up
| Study group | Role | What they receive |
|---|---|---|
| bevel down | Experimental | approaching the IJV with the needle bevel facing down Receives: Device: bevel direction during central venous catheterization |
| bevel up | Active comparator | approaching the IJV with the needle bevel facing up Receives: Device: bevel direction during central venous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
posterior wall puncture of internal jugular vein
Measured: immediately after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003366
- Sponsor's protocol ID
- JHBahk_CVC bevel
- Status last verified
- Mar 2011
- First submitted
- 27 Oct 2009
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
- ClinicalTrials.gov ID
- NCT01003366
- Acronym / sponsor ID
- JHBahk_CVC bevel
- Conditions
- Central Venous Catheterization
- Keywords
- safety during central venous catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Oct 2009 (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.
To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevel down | Experimental | Device: bevel direction during central venous catheterizationapproaching the IJV with the needle bevel facing down |
| bevel up | Active comparator | Device: bevel direction during central venous catheterizationapproaching the IJV with the needle bevel facing up |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein
Key exclusion criteria (2 listed)
- anatomical anomaly in the neck region
- recent history of central venous catheterization
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 |
|---|---|---|
| bevel direction during central venous catheterizationapproaching the IJV with the needle bevel facing down | Device | bevel down |
| bevel direction during central venous catheterizationapproaching the IJV with the needle bevel facing up | Device | bevel up |
Primary outcome
posterior wall puncture of internal jugular vein
Time frame: immediately after catheterization
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 22 Mar 2011.
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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.
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 bevel direction during central venous catheterization in people with Central Venous Catheterization, 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 22 Mar 2011. 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?
posterior wall puncture of internal jugular vein (time frame: immediately after catheterization). 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 22 Mar 2011.