HematomaNCT01026649
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
A study testing Central venous catheterization in people with Hematoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hematoma
- What is being tested?
- Central venous catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2009to May 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require a central venous catheter for their thoracic surgery
Who cannot join
- Refuse to enroll
- Infection at insertion site
- Carotid artery disease
- Anomaly of central vasculature
- Hypertrophied thyroid
- History of recent neck surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.
- Conditions
- Hematoma
- Being tested
- Central venous catheterization
- Keywords
- hematoma formation, success rate
- Medical subject headings
- Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterizationProcedure or surgery
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
Central venous catheterizationProcedure or surgery
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
| Study group | Role | What they receive |
|---|---|---|
| 2 stage | Experimental | Approach the internal jugular vein in a 2 stage fashion during central venous catheterization Receives: Procedure: Central venous catheterization |
| 1 stage | Active comparator | Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization Receives: Procedure: Central venous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma formation
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 posted4 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026649
- Sponsor's protocol ID
- JHBahk_CVC two stage
- Status last verified
- Apr 2016
- First submitted
- 19 Nov 2009
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
- ClinicalTrials.gov ID
- NCT01026649
- Acronym / sponsor ID
- JHBahk_CVC two stage
- Conditions
- Hematoma
- Keywords
- hematoma formation, success rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Dec 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 evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 stage | Experimental | Procedure: Central venous catheterizationApproach the internal jugular vein in a 2 stage fashion during central venous catheterization |
| 1 stage | Active comparator | Procedure: Central venous catheterizationApproach the internal jugular vein in a traditional one stage fashion during central venous catheterization |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who require a central venous catheter for their thoracic surgery
Key exclusion criteria (6 listed)
- Refuse to enroll
- Infection at insertion site
- Carotid artery disease
- Anomaly of central vasculature
- Hypertrophied thyroid
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 |
|---|---|---|
| Central venous catheterizationApproach the internal jugular vein in a traditional one stage fashion during central venous catheterization | Procedure or surgery | 1 stage |
| Central venous catheterizationApproach the internal jugular vein in a 2 stage fashion during central venous catheterization | Procedure or surgery | 2 stage |
Primary outcome
hematoma formation
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 20 Apr 2016.
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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 Central venous catheterization in people with Hematoma, 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 6 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 Apr 2016. 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?
hematoma formation (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 20 Apr 2016.