Cardiac Surgical ProceduresNCT03405623
Dynamic SAX vs Conventional LAX in Radial Artery Cannulation.
A study testing Dynamic needle tip positioning under ultrasound-guidance and Conventional long-axis view in people with Cardiac Surgical Procedures and Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
When performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, 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
- 30 Jan 2018to 4 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiovascular surgery where RA catheterization is newly required.
Who cannot join
- skin infection or trauma
- Bilateral arteriovenous fistula for dialysis
- Severe peripheral vascular disease
- Severe arteriosclerosis or arterial atheroma
- Raynaud disease
- Shock
Show all 10Show fewer
- Patients on ECMO or IABP support
- Morbid obesity
- Profound coagulopathy
- Negative results of modified Allen's test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Ultrasound-guided Radial Artery Cannulation Using Dynamic Short Axis Versus Conventional Long-axis In-plane View in Cardiac Surgery Patients.
When performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP) method is newly introduced by one group of investigators who conducted a related study using vascular phantom model.
In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.
DNTP has not been compared to conventional imaging methods. The aim of this trial is to see the effect of DNTP on success rate of the radial artery cannulation at the first attempt, compared to the conventional LAX.
- 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 | In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an hyper-echoic point, the practitioner (a) moves the US probe proximally a bit, and (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure. Receives: Procedure: Dynamic needle tip positioning under ultrasound-guidance |
| Conventional long-axis | Active comparator | Not described Receives: Procedure: Conventional long-axis view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the radial artery cannulation at first attempt
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
Measured: intraoperative
Secondary outcomes (1)
Time between skin puncture to confirmation of the arterial waveform through a pressure monitoring device.
Measured: During the cannulation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start30 Jan 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405623
- Sponsor's protocol ID
- DNTP vs LAX
- Status last verified
- Sep 2018
- First submitted
- 15 Jan 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
PubMed 34637140
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Ultrasound-guided Radial Artery Cannulation Using Dynamic Short Axis Versus Conventional Long-axis In-plane View in Cardiac Surgery Patients.
- ClinicalTrials.gov ID
- NCT03405623
- Acronym / sponsor ID
- DNTP vs LAX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 23 Jan 2018 (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 performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP) method is newly introduced by one group of investigators who conducted a related study using vascular phantom model.
In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.
DNTP has not been compared to conventional imaging methods. The aim of this trial is to see the effect of DNTP on success rate of the radial artery cannulation at the first attempt, compared to the conventional LAX.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic needle tip positioning | Active comparator | Procedure: Dynamic needle tip positioning under ultrasound-guidanceIn DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an hyper-echoic point, the practitioner (a) moves the US probe proximally a bit, and (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure. |
| Conventional long-axis | Active comparator | Procedure: Conventional long-axis view |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective cardiovascular surgery where RA catheterization is newly required.
Key exclusion criteria (10 listed)
- skin infection or trauma
- Bilateral arteriovenous fistula for dialysis
- Severe peripheral vascular disease
- Severe arteriosclerosis or arterial atheroma
- Raynaud disease
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
Success rate of the radial artery cannulation at first attempt
Time frame: intraoperative
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
1 secondary outcome
Time between skin puncture to confirmation of the arterial waveform through a pressure monitoring device.
Time frame: During the cannulation procedure.
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 Sep 2018.
- Derived from this study: PubMed 34637140Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
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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 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 10 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 Sep 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?
Success rate of the radial artery cannulation at first attempt (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 NCT03405623, which also lists 1 linked publication.
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 Sep 2018.