Brain TumorNCT01510743
Ultrasound Guided Central Vein Catheterization and Complications
A study testing Catheterization of subclavian vein and Catheterization of internal jugular vein in people with Brain Tumor, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Catheterization of subclavian vein and Catheterization of internal jugular vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,484 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2012to Apr 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.
Who cannot join
- Refuse
- hematologic disorder
- Anatomical abnormalities of central vein structure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyounggi, 463-707
About this study
Official title: Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization
There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate.
- Conditions
- Brain Tumor
- Being tested
- Catheterization of subclavian vein, Catheterization of internal jugular vein
- Keywords
- open heart surgery, lung surgery, spine surgery, hepatobiliary surgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization of subclavian veinProcedure or surgery
Catheterization of subclavian vein
Catheterization of internal jugular veinProcedure or surgery
Catheterization of internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| Group SC | Active comparator | US guided subclavian vein catheterization Receives: Procedure: Catheterization of subclavian vein |
| Group IJ | Active comparator | US-guided internal jugular vein catheterization Receives: Procedure: Catheterization of internal jugular vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication
any one of arterial puncture, hematoma, pneumothorax, hemothorax
Measured: during central vein catheterization and operation day
Secondary outcomes (3)
Access time
from penetration of skin to aspiration of venous blood into the syringe
Measured: during central venous catheterization
Number of attempts
once/twice/three times
Measured: during central venous catheterization
catheter tip placement
After reviewing the postoperative chest X ray film, we will check the position of the central venous catheter tip. The possible pisition of catheter tip is as follows:
(1) Superior vena cava and Rirht Atrium junction (2)Right internal jugular vein (3)Left Internal jugular vein (4)Right Axillary vein (5)Lt. Axillary vein
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study start30 Jan 2012
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- 1,484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
- Investigators
- Jin-Hee Kim, Professor, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510743
- Sponsor's protocol ID
- B1112_069_003
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2012
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization
- ClinicalTrials.gov ID
- NCT01510743
- Acronym / sponsor ID
- B1112_069_003
- Conditions
- Brain Tumor
- Keywords
- open heart surgery, lung surgery, spine surgery, hepatobiliary surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,484 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 30 Jan 2012 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 16 Jan 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.
There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group SC | Active comparator | Procedure: Catheterization of subclavian veinUS guided subclavian vein catheterization |
| Group IJ | Active comparator | Procedure: Catheterization of internal jugular veinUS-guided internal jugular vein catheterization |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.
Key exclusion criteria (3 listed)
- Refuse
- hematologic disorder
- Anatomical abnormalities of central vein structure
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 |
|---|---|---|
| Catheterization of subclavian veinCatheterization of subclavian vein | Procedure or surgery | Group SC |
| Catheterization of internal jugular veinCatheterization of internal jugular vein | Procedure or surgery | Group IJ |
Primary outcome
complication
Time frame: during central vein catheterization and operation day
any one of arterial puncture, hematoma, pneumothorax, hemothorax
3 secondary outcomes
Access time
Time frame: during central venous catheterization
Number of attempts
Time frame: during central venous catheterization
catheter tip placement
Time frame: postoperative 1 day
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 27 Aug 2018.
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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-Hee Kim, Professor study director
Seoul National University Bundang 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 Catheterization of subclavian vein and Catheterization of internal jugular vein in people with Brain Tumor, run by Seoul National University Bundang 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 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 27 Aug 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?
complication (time frame: during central vein catheterization and operation day). 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 27 Aug 2018.