Catheterization, Central VenousNCT03936543
Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.
A study testing Position change and Conventional position in people with Catheterization, Central Venous, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Position change and Conventional position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2019to 30 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central venous catheterization required on lt. IJV
Who cannot join
- History of cervical spine surgery
- Abnormal structure of cervical spine, carotid artery or jugular vein
- Disease of carotid artery
- Immobilization due to cervical spine fracture or other diseases.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 07061
Tae Kyong Kim, MD, 82-10-3750-5193, ktkktk@gmail.com
Dong Wook Won, MD, 82-10-3194-9471, won2501@naver.com
About this study
Official title: Comparison of the Needle Tip Location According to the Position of the Operator During Short Axis Ultrasound Guided Central Venous Catheterization in the Left Internal Jugular Vein
When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.
Read the detailed description
When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)
- Conditions
- Catheterization, Central Venous
- Being tested
- Position change, Conventional position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position changeOther
Different position during central line catheterization
Conventional positionOther
Conventional position during central line catheterization
| Study group | Role | What they receive |
|---|---|---|
| Extended axillary midline | Experimental | Operator stands at the bedside on extended midline of the patient's lt. axilla during lt. internal jugular vein catheterization Receives: Other: Position change |
| Extended head midline | Active comparator | Operator stands at the bedside on extended midline of the patient's head during lt. internal jugular vein catheterization. Receives: Other: Conventional position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance from needle tip to center of IJV
The distance that the needle tip is placed from the center of the jugular vein when the needle is fixed after the vascular puncture
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start2 May 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, Seoul National University Hospital
- Investigators
- Tae Kyong Kim, MD, phD, Study director, SMG-SNU Boramae hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936543
- Sponsor's protocol ID
- 20190311/10-2019-7/041
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ishizuka M, Nagata H, Takagi K, Kubota K. Right internal jugular vein is recommended for central venous catheterization. J Invest Surg. 2010 Apr;23(2):110-4. doi: 10.3109/08941930903469342.
PubMed 20497014Lobato EB, Sulek CA, Moody RL, Morey TE. Cross-sectional area of the right and left internal jugular veins. J Cardiothorac Vasc Anesth. 1999 Apr;13(2):136-8. doi: 10.1016/s1053-0770(99)90075-7.
PubMed 10230944Sulek CA, Blas ML, Lobato EB. A randomized study of left versus right internal jugular vein cannulation in adults. J Clin Anesth. 2000 Mar;12(2):142-5. doi: 10.1016/s0952-8180(00)00129-x.
PubMed 10818329Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.
PubMed 15385337Min SW, Kim H, Won D, Chang JE, Lee JM, Hwang JY, Kim TK. Comparison of the needle tip location with the operator's position during ultrasound-guided internal jugular vein catheterization: A randomized controlled study. Medicine (Baltimore). 2022 Oct 28;101(43):e31249. doi: 10.1097/MD.0000000000031249.
PubMed 36316874
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Needle Tip Location According to the Position of the Operator During Short Axis Ultrasound Guided Central Venous Catheterization in the Left Internal Jugular Vein
- ClinicalTrials.gov ID
- NCT03936543
- Acronym / sponsor ID
- 20190311/10-2019-7/041
- Conditions
- Catheterization, Central Venous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- 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.
When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.
Detailed description
When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended axillary midline | Experimental | Other: Position changeOperator stands at the bedside on extended midline of the patient's lt. axilla during lt. internal jugular vein catheterization |
| Extended head midline | Active comparator | Other: Conventional positionOperator stands at the bedside on extended midline of the patient's head during lt. internal jugular vein catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Central venous catheterization required on lt. IJV
Key exclusion criteria (4 listed)
- History of cervical spine surgery
- Abnormal structure of cervical spine, carotid artery or jugular vein
- Disease of carotid artery
- Immobilization due to cervical spine fracture or other diseases.
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 |
|---|---|---|
| Position changeDifferent position during central line catheterization | Other | Extended axillary midline |
| Conventional positionConventional position during central line catheterization | Other | Extended head midline |
Primary outcome
Distance from needle tip to center of IJV
Time frame: intraoperative
The distance that the needle tip is placed from the center of the jugular vein when the needle is fixed after the vascular puncture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Background: PubMed 20497014Ishizuka M, Nagata H, Takagi K, Kubota K. Right internal jugular vein is recommended for central venous catheterization. J Invest Surg. 2010 Apr;23(2):110-4. doi: 10.3109/08941930903469342.
- Background: PubMed 10230944Lobato EB, Sulek CA, Moody RL, Morey TE. Cross-sectional area of the right and left internal jugular veins. J Cardiothorac Vasc Anesth. 1999 Apr;13(2):136-8. doi: 10.1016/s1053-0770(99)90075-7.
- Background: PubMed 10818329Sulek CA, Blas ML, Lobato EB. A randomized study of left versus right internal jugular vein cannulation in adults. J Clin Anesth. 2000 Mar;12(2):142-5. doi: 10.1016/s0952-8180(00)00129-x.
- Background: PubMed 15385337Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.
- Derived from this study: PubMed 36316874Min SW, Kim H, Won D, Chang JE, Lee JM, Hwang JY, Kim TK. Comparison of the needle tip location with the operator's position during ultrasound-guided internal jugular vein catheterization: A randomized controlled study. Medicine (Baltimore). 2022 Oct 28;101(43):e31249. doi: 10.1097/MD.0000000000031249.
- Individual participant dataSharing planned: No
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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.
Tae Kyong Kim, MD, phD study director
SMG-SNU Boramae 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 Position change and Conventional position in people with Catheterization, Central Venous, 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 4 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: status not confirmed, as of the sponsor's last update on 3 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Kyong Kim, MD, phD (+82-2-870-2519, ktkktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance from needle tip to center of IJV (time frame: intraoperative). 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 NCT03936543, which also lists 5 linked publications.
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 3 May 2019.