Radial Artery CannulationNCT07708532
Biplanar Handheld Ultrasound for Transradial Artery Puncture
A study testing Biplanar handheld ultrasound system and Conventional high-frequency linear-array ultrasound system in people with Radial Artery Cannulation, run by Shanghai Fourth People's Hospital Tongji University at 1 site in China.
Trial summary
Radial artery puncture is commonly used to obtain vascular access for cerebral angiography and neurointerventional procedures. Conventional ultrasound guidance usually provides either a short-axis or a long-axis view of the radial artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Cannulation
- What is being tested?
- Biplanar handheld ultrasound system and Conventional high-frequency linear-array ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older, regardless of sex, who are scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach.
- Adequate collateral circulation between the radial and ulnar arteries, as demonstrated by the modified Allen test or vascular ultrasound.
- Radial artery diameter of at least 1.5 mm on preprocedural ultrasound examination.
- Ability to understand the study procedures, willingness to participate voluntarily, and provision of written informed consent.
Who cannot join
- Infection or skin damage at the intended puncture site; known radial artery occlusion or severe stenosis; or inadequate collateral circulation between the radial and ulnar arteries.
- Radial artery diameter of less than 1.5 mm on preprocedural ultrasound examination, or severe radial artery tortuosity or anatomical variation that may interfere with the puncture procedure.
- Previous puncture, surgery, or trauma involving the radial artery on the intended puncture side that may have altered the local anatomy.
- Hemodynamic instability requiring urgent hemodynamic support, including cardiogenic shock or severe hypotension.
- Impaired consciousness, psychiatric illness, or any other condition that prevents the participant from cooperating with the study procedures or completing the required follow-up.
- Severe coagulation abnormality, defined as an international normalized ratio greater than 1.8 or a platelet count below 80 × 10^9/L.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, 200435
About this study
Official title: Tuoren Biplanar Combined Handheld Ultrasound Versus Conventional Ultrasound for Transradial Artery Puncture A Prospective Randomized Parallel Single-Center Superiority Clinical Study
Radial artery puncture is commonly used to obtain vascular access for cerebral angiography and neurointerventional procedures. Conventional ultrasound guidance usually provides either a short-axis or a long-axis view of the radial artery. A biplanar handheld ultrasound system can provide simultaneous long-axis and short-axis views, which may help the operator visualize the puncture needle and radial artery more clearly.
This prospective, single-center, randomized, parallel-group superiority trial will compare the TUOREN biplanar handheld ultrasound system with a conventional high-frequency linear-array ultrasound system for ultrasound-guided radial artery puncture. A total of 152 adults scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach will be randomly assigned in a 1:1 ratio to one of the two ultrasound-guidance groups.
The main objective is to determine whether biplanar handheld ultrasound guidance improves the percentage of participants with successful radial artery cannulation on the first puncture attempt. Other assessments include the total number of puncture attempts, cumulative active puncture time, fixation time after successful cannulation, and the occurrence of posterior wall puncture.
Read the detailed description
Ultrasound guidance is used to improve visualization of the radial artery during vascular access. Conventional high-frequency linear-array ultrasound systems provide either a short-axis or a long-axis image, depending on probe orientation and puncture technique. During puncture, the operator may need to adjust the probe repeatedly to maintain visualization of the needle tip and its position relative to the radial artery.
The TUOREN biplanar handheld ultrasound system uses a T-shaped dual-probe configuration to display simultaneous long-axis and short-axis views of the radial artery and puncture needle. The long-axis view is intended to show the needle trajectory and advancement, while the short-axis view is intended to show the lateral position of the needle relative to the vessel.
This is a prospective, randomized, parallel-group, single-center superiority trial conducted at Shanghai Fourth People's Hospital. Eligible participants scheduled for cerebral angiography or neurointerventional treatment through a transradial approach will be allocated in a 1:1 ratio using block randomization with allocation concealment.
Participants in the experimental group will undergo radial artery puncture guided by the TUOREN biplanar handheld ultrasound system. Participants in the active comparator group will undergo radial artery puncture guided by a conventional high-frequency linear-array ultrasound system using either a short-axis out-of-plane technique or a long-axis in-plane technique. Other components of the radial artery cannulation procedure will be standardized between the two groups.
The study is designed to evaluate whether simultaneous biplanar ultrasound visualization improves first-attempt radial artery cannulation success and procedural efficiency compared with conventional ultrasound guidance. Puncture attempts, procedure-related time intervals, and ultrasound findings will be recorded according to prespecified study definitions.
- Conditions
- Radial Artery Cannulation
- Being tested
- Biplanar handheld ultrasound system, Conventional high-frequency linear-array ultrasound system
- Keywords
- Ultrasound-guided radial artery cannulation, Biplanar ultrasound, Handheld ultrasound, Transradial access, Vascular access, First-attempt success, TUOREN biplanar handheld ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biplanar handheld ultrasound systemDevice
A biplanar handheld ultrasound system used to guide radial artery puncture. Its T-shaped dual-probe configuration provides simultaneous long-axis and short-axis views of the radial artery and puncture needle.
Conventional high-frequency linear-array ultrasound systemDevice
A conventional high-frequency linear-array ultrasound system used to guide radial artery puncture using either a short-axis out-of-plane technique or a long-axis in-plane technique.
| Study group | Role | What they receive |
|---|---|---|
| TUOREN Biplanar Handheld Ultrasound Guidance | Experimental | Participants assigned to this arm will undergo transradial artery puncture guided by TUOREN biplanar handheld ultrasound which provides simultaneous long-axis and short-axis views. Receives: Device: Biplanar handheld ultrasound system |
| Conventional Ultrasound Guidance | Active comparator | Participants assigned to this arm will undergo transradial artery puncture guided by a conventional high-frequency linear array ultrasound probe using short-axis out-of-plane or long-axis in-plane techniques. Receives: Device: Conventional high-frequency linear-array ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success rate
Proportion of participants with successful radial artery cannulation on the first continuous puncture attempt. Success is confirmed by sustained blood return guidewire advancement at least 5 to 10 cm without resistance and an arterial pressure waveform after catheter connection.
Measured: During the puncture procedure
Secondary outcomes (7)
Mean total number of puncture attempts required for successful radial artery cannulation
The total number of puncture attempts required to achieve successful radial artery cannulation will be recorded for each participant. An attempt begins when the needle first contacts the skin and ends when successful cannulation is confirmed or when the needle is completely withdrawn from the skin. Each reinsertion after complete withdrawal of the needle from the skin is counted as a new attempt. The outcome will be reported as the mean number of puncture attempts per participant.
Measured: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
Mean cumulative active puncture time to successful radial artery cannulation
Cumulative active puncture time is defined as the total active puncture time, measured in seconds, from the first needle-to-skin contact until successful radial artery cannulation is confirmed by an arterial pressure waveform. Timing will be paused whenever the needle is completely withdrawn from the skin and resumed when the needle contacts the skin for the next attempt. Time used for skin preparation, draping, ultrasound probe preparation, and intervals between puncture attempts will not be included. The outcome will be reported as the mean cumulative active puncture time per participant.
Measured: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
Mean time required for catheter fixation after successful radial artery cannulation
Catheter fixation time is defined as the time, measured in seconds, from confirmation of successful radial artery cannulation by an arterial pressure waveform until the catheter is securely fixed and the dressing is completed. The outcome will be reported as the mean catheter fixation time per participant.
Measured: From confirmation of successful radial artery cannulation until completion of catheter fixation and dressing during the index procedure
Percentage of participants with posterior wall puncture
Posterior wall puncture is defined as visualization of the needle tip penetrating the posterior wall of the radial artery during any puncture attempt. A participant will be classified as having posterior wall puncture if at least one such event occurs during the procedure. The event will be identified by the operator during the procedure or confirmed through review of the recorded ultrasound images or video. The outcome will be reported as the percentage of participants with at least one posterior wall puncture.
Measured: From the first puncture attempt until confirmation of successful radial artery cannulation during the index procedure
Mean systolic blood pressure before the first puncture attempt
Systolic blood pressure will be measured in millimeters of mercury within 1 minute before the first puncture attempt. The outcome will be reported as the mean systolic blood pressure per participant.
Measured: Within 1 minute before the first puncture attempt of the index procedure
Mean diastolic blood pressure before the first puncture attempt
Diastolic blood pressure will be measured in millimeters of mercury within 1 minute before the first puncture attempt. The outcome will be reported as the mean diastolic blood pressure per participant.
Measured: Within 1 minute before the first puncture attempt of the index procedure
Mean heart rate before the first puncture attempt
Heart rate will be measured in beats per minute within 1 minute before the first puncture attempt. The outcome will be reported as the mean heart rate per participant.
Measured: Within 1 minute before the first puncture attempt of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery CannulationStudies of the same condition, open and under way.
- 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
- Model description
- This is a single-center, prospective, randomized, parallel-group superiority trial. Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment to undergo transradial artery puncture guided by either a biplanar handheld ultrasound system or a conventional high-frequency linear-array ultrasound system. Each participant will receive only the assigned ultrasound-guidance method during the index procedure.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Fourth People's Hospital Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yibin Fang, Shanghai Fourth People's Hospital Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708532
- Sponsor's protocol ID
- 2026027-001
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuoren Biplanar Combined Handheld Ultrasound Versus Conventional Ultrasound for Transradial Artery Puncture A Prospective Randomized Parallel Single-Center Superiority Clinical Study
- ClinicalTrials.gov ID
- NCT07708532
- Acronym / sponsor ID
- 2026027-001
- Conditions
- Radial Artery Cannulation
- Keywords
- Ultrasound-guided radial artery cannulation, Biplanar ultrasound, Handheld ultrasound, Transradial access, Vascular access, First-attempt success, TUOREN biplanar handheld ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Shanghai Fourth People's Hospital Tongji UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 Jul 2026 (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.
Radial artery puncture is commonly used to obtain vascular access for cerebral angiography and neurointerventional procedures. Conventional ultrasound guidance usually provides either a short-axis or a long-axis view of the radial artery. A biplanar handheld ultrasound system can provide simultaneous long-axis and short-axis views, which may help the operator visualize the puncture needle and radial artery more clearly.
This prospective, single-center, randomized, parallel-group superiority trial will compare the TUOREN biplanar handheld ultrasound system with a conventional high-frequency linear-array ultrasound system for ultrasound-guided radial artery puncture. A total of 152 adults scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach will be randomly assigned in a 1:1 ratio to one of the two ultrasound-guidance groups.
The main objective is to determine whether biplanar handheld ultrasound guidance improves the percentage of participants with successful radial artery cannulation on the first puncture attempt. Other assessments include the total number of puncture attempts, cumulative active puncture time, fixation time after successful cannulation, and the occurrence of posterior wall puncture.
Detailed description
Ultrasound guidance is used to improve visualization of the radial artery during vascular access. Conventional high-frequency linear-array ultrasound systems provide either a short-axis or a long-axis image, depending on probe orientation and puncture technique. During puncture, the operator may need to adjust the probe repeatedly to maintain visualization of the needle tip and its position relative to the radial artery.
The TUOREN biplanar handheld ultrasound system uses a T-shaped dual-probe configuration to display simultaneous long-axis and short-axis views of the radial artery and puncture needle. The long-axis view is intended to show the needle trajectory and advancement, while the short-axis view is intended to show the lateral position of the needle relative to the vessel.
This is a prospective, randomized, parallel-group, single-center superiority trial conducted at Shanghai Fourth People's Hospital. Eligible participants scheduled for cerebral angiography or neurointerventional treatment through a transradial approach will be allocated in a 1:1 ratio using block randomization with allocation concealment.
Participants in the experimental group will undergo radial artery puncture guided by the TUOREN biplanar handheld ultrasound system. Participants in the active comparator group will undergo radial artery puncture guided by a conventional high-frequency linear-array ultrasound system using either a short-axis out-of-plane technique or a long-axis in-plane technique. Other components of the radial artery cannulation procedure will be standardized between the two groups.
The study is designed to evaluate whether simultaneous biplanar ultrasound visualization improves first-attempt radial artery cannulation success and procedural efficiency compared with conventional ultrasound guidance. Puncture attempts, procedure-related time intervals, and ultrasound findings will be recorded according to prespecified study definitions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized, parallel-group superiority trial. Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment to undergo transradial artery puncture guided by either a biplanar handheld ultrasound system or a conventional high-frequency linear-array ultrasound system. Each participant will receive only the assigned ultrasound-guidance method during the index procedure.
| Arm | Type | Receives |
|---|---|---|
| TUOREN Biplanar Handheld Ultrasound Guidance | Experimental | Device: Biplanar handheld ultrasound systemParticipants assigned to this arm will undergo transradial artery puncture guided by TUOREN biplanar handheld ultrasound which provides simultaneous long-axis and short-axis views. |
| Conventional Ultrasound Guidance | Active comparator | Device: Conventional high-frequency linear-array ultrasound systemParticipants assigned to this arm will undergo transradial artery puncture guided by a conventional high-frequency linear array ultrasound probe using short-axis out-of-plane or long-axis in-plane techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older, regardless of sex, who are scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach.
- Adequate collateral circulation between the radial and ulnar arteries, as demonstrated by the modified Allen test or vascular ultrasound.
- Radial artery diameter of at least 1.5 mm on preprocedural ultrasound examination.
- Ability to understand the study procedures, willingness to participate voluntarily, and provision of written informed consent.
Key exclusion criteria (6 listed)
- Infection or skin damage at the intended puncture site; known radial artery occlusion or severe stenosis; or inadequate collateral circulation between the radial and ulnar arteries.
- Radial artery diameter of less than 1.5 mm on preprocedural ultrasound examination, or severe radial artery tortuosity or anatomical variation that may interfere with the puncture procedure.
- Previous puncture, surgery, or trauma involving the radial artery on the intended puncture side that may have altered the local anatomy.
- Hemodynamic instability requiring urgent hemodynamic support, including cardiogenic shock or severe hypotension.
- Impaired consciousness, psychiatric illness, or any other condition that prevents the participant from cooperating with the study procedures or completing the required follow-up.
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 |
|---|---|---|
| Biplanar handheld ultrasound systemA biplanar handheld ultrasound system used to guide radial artery puncture. Its T-shaped dual-probe configuration provides simultaneous long-axis and short-axis views of the radial artery and puncture needle. | Device | TUOREN Biplanar Handheld Ultrasound Guidance |
| Conventional high-frequency linear-array ultrasound systemA conventional high-frequency linear-array ultrasound system used to guide radial artery puncture using either a short-axis out-of-plane technique or a long-axis in-plane technique. | Device | Conventional Ultrasound Guidance |
Primary outcome
First-attempt success rate
Time frame: During the puncture procedure
Proportion of participants with successful radial artery cannulation on the first continuous puncture attempt. Success is confirmed by sustained blood return guidewire advancement at least 5 to 10 cm without resistance and an arterial pressure waveform after catheter connection.
7 secondary outcomes
Mean total number of puncture attempts required for successful radial artery cannulation
Time frame: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
Mean cumulative active puncture time to successful radial artery cannulation
Time frame: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
Mean time required for catheter fixation after successful radial artery cannulation
Time frame: From confirmation of successful radial artery cannulation until completion of catheter fixation and dressing during the index procedure
Percentage of participants with posterior wall puncture
Time frame: From the first puncture attempt until confirmation of successful radial artery cannulation during the index procedure
Mean systolic blood pressure before the first puncture attempt
Time frame: Within 1 minute before the first puncture attempt of the index procedure
Mean diastolic blood pressure before the first puncture attempt
Time frame: Within 1 minute before the first puncture attempt of the index procedure
Mean heart rate before the first puncture attempt
Time frame: Within 1 minute before the first puncture attempt of the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Radial Artery Cannulation
Recruiting
Short-Axis Versus Long-Axis Ultrasound-Guided Radial Artery Cannulation
Radial Artery Cannulation
Not yet recruiting
Nurse vs Physician Artery Cannulation
Educational Problems, Catheterization
Not yet recruiting
Direct vs. Seldinger Technique for Ultrasound-Guided Difficult Radial Access in Cardiac Surgery
Cardiac Surgery in Adult Patient, Cardiac Surgery
RecruitingObservational study
Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients
Ulnar and Radial Artery
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 Biplanar handheld ultrasound system and Conventional high-frequency linear-array ultrasound system in people with Radial Artery Cannulation, run by Shanghai Fourth People's Hospital Tongji University at 1 site in China.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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-attempt success rate (time frame: During the puncture procedure). 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 16 Jul 2026.