Cardiac Surgical ProceduresNCT03841968
Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization
A study testing Dynamic needle tip positioning under ultrasound-guidance and Conventional long-axis view in people with Cardiac Surgical Procedures and Central Venous Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization. SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Central Venous Catheterization, Ultrasonography
- What is being tested?
- Dynamic needle tip positioning under ultrasound-guidance and Conventional long-axis view
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2019to 9 Dec 2019
- 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
- Elective cardiac surgery where central venous catheterization is required.
Who cannot join
- skin infection or trauma
- Shock
- Patients on ECMO or IABP support
- Morbid obesity
- Profound coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial
Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization.
SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel.
The aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.
- Being tested
- Dynamic needle tip positioning under ultrasound-guidance, Conventional long-axis view
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic needle tip positioning under ultrasound-guidanceProcedure or surgery
The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
Conventional long-axis viewProcedure or surgery
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic needle tip positioning | Active comparator | Dynamic needle tip positioning Receives: Procedure: Dynamic needle tip positioning under ultrasound-guidance |
| Conventional long-axis | Active comparator | Conventional long-axis Receives: Procedure: Conventional long-axis view |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
Measured: Intraoperative
Secondary outcomes (2)
Total procedure time
Total procedure time
Measured: Intraoperative
Rate of posterior wall puncture_assessed by ultrasound
Rate of posterior wall puncture_assessed by ultrasound
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Mar 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841968
- Sponsor's protocol ID
- DNTP IJV
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial
- ClinicalTrials.gov ID
- NCT03841968
- Acronym / sponsor ID
- DNTP IJV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 15 Feb 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.
Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization.
SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel.
The aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic needle tip positioning | Active comparator | Procedure: Dynamic needle tip positioning under ultrasound-guidanceDynamic needle tip positioning |
| Conventional long-axis | Active comparator | Procedure: Conventional long-axis viewConventional long-axis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cardiac surgery where central venous catheterization is required.
Key exclusion criteria (5 listed)
- skin infection or trauma
- Shock
- Patients on ECMO or IABP support
- Morbid obesity
- Profound coagulopathy
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 |
|---|---|---|
| Dynamic needle tip positioning under ultrasound-guidanceThe tip of needle is positioned under ultrasound-guidance using dynamic short-axis view. | Procedure or surgery | Dynamic needle tip positioning |
| Conventional long-axis viewThe tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view. | Procedure or surgery | Conventional long-axis |
Primary outcome
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
Time frame: Intraoperative
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
2 secondary outcomes
Total procedure time
Time frame: Intraoperative
Rate of posterior wall puncture_assessed by ultrasound
Time frame: Intraoperative
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 28 Feb 2020.
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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 Dynamic needle tip positioning under ultrasound-guidance and Conventional long-axis view in people with Cardiac Surgical Procedures and 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 5 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 28 Feb 2020. 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?
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor (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 28 Feb 2020.