Jugular VeinsNCT02878174
The Site of Puncture in Prelocation Technique of the Internal Jugular Venous Catheterization
A study testing internal jugular vein catheterization in people with Jugular Veins, run by Seoul National University Hospital.
Trial summary
Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Jugular Veins
- What is being tested?
- internal jugular vein catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jul 2026
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for general anesthesia
Who cannot join
- Refusal of consent
- Patients with cervical spine injuries
- Patients with atlanto-axial instability
- Patients at risk of increased intracranial pressure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Site of Puncture in Ultrasound-guided Prelocation Technique of the Internal Jugular Venous Catheterization: Non-inferiority Randomized Clinical Trial
Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.
Read the detailed description
The investigator's own developed screen-rotating program is used. An accelerometer is attached on the front surface of the ultrasound (US) probe. The angle of rotation of the probe is delivered to the laptop and becomes the information to adjust the rotating angle of screen. Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees. In the US group, the investigators obtain a sonographic view and try a cannulation of the internal jugular vein (IJV). In the prelocation group, a skin marker is made on the anticipated skin puncture site where a perpendicular line that passes over the center of the IJV meets the skin on the rotated US screen. It is recorded "success" when the internal jugular vein is successfully punctured without complications. It is recorded "failure" if the internal jugular vein is not punctured during repeated needle passes. The number of tries and tile to success are recorded. The success and complication rates between two groups are compared.
- Conditions
- Jugular Veins
- Being tested
- internal jugular vein catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal jugular vein catheterizationProcedure or surgery
internal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques
| Study group | Role | What they receive |
|---|---|---|
| conventional ultrasound (US)-guided group | Active comparator | internal jugular vein catheterization using conventional US-guided internal jugular vein (IJV) cannulation Receives: Procedure: internal jugular vein catheterization |
| rotational Prelocation group | Experimental | internal jugular vein catheterization using landmark approach based on the rotation-adjusted US screen Receives: Procedure: internal jugular vein catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of internal jugular vein cannulation
Measured: intraoperative
Secondary outcomes (1)
Degree of rotation of ultrasound (US) probe
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jugular VeinsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul-Woo Jung, Seoul National University Hospital
- Investigators
- Chul-Woo Jung, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878174
- Sponsor's protocol ID
- IJV_rotation
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2016
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Site of Puncture in Ultrasound-guided Prelocation Technique of the Internal Jugular Venous Catheterization: Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02878174
- Acronym / sponsor ID
- IJV_rotation
- Conditions
- Jugular Veins
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Aug 2016 (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.
Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.
Detailed description
The investigator's own developed screen-rotating program is used. An accelerometer is attached on the front surface of the ultrasound (US) probe. The angle of rotation of the probe is delivered to the laptop and becomes the information to adjust the rotating angle of screen. Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees. In the US group, the investigators obtain a sonographic view and try a cannulation of the internal jugular vein (IJV). In the prelocation group, a skin marker is made on the anticipated skin puncture site where a perpendicular line that passes over the center of the IJV meets the skin on the rotated US screen. It is recorded "success" when the internal jugular vein is successfully punctured without complications. It is recorded "failure" if the internal jugular vein is not punctured during repeated needle passes. The number of tries and tile to success are recorded. The success and complication rates between two groups are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ultrasound (US)-guided group | Active comparator | Procedure: internal jugular vein catheterizationinternal jugular vein catheterization using conventional US-guided internal jugular vein (IJV) cannulation |
| rotational Prelocation group | Experimental | Procedure: internal jugular vein catheterizationinternal jugular vein catheterization using landmark approach based on the rotation-adjusted US screen |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for general anesthesia
Key exclusion criteria (4 listed)
- Refusal of consent
- Patients with cervical spine injuries
- Patients with atlanto-axial instability
- Patients at risk of increased intracranial pressure
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 |
|---|---|---|
| internal jugular vein catheterizationinternal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques | Procedure or surgery | conventional ultrasound (US)-guided group, rotational Prelocation group |
Primary outcome
Success rate of internal jugular vein cannulation
Time frame: intraoperative
1 secondary outcome
Degree of rotation of ultrasound (US) probe
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- 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.
Chul-Woo Jung, MD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing internal jugular vein catheterization in people with Jugular Veins, run by Seoul National University Hospital.
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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Chul-Woo Jung Jung, MD (2-2-2072-0640, jungcwoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of internal jugular vein cannulation (time frame: intraoperative). 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 1 Dec 2023.