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NCT07708532
Biplanar Handheld Ultrasound for Transradial Artery Puncture
Conditions: Radial Artery Cannulation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 152
Sponsor: Shanghai Fourth People's Hospital Tongji University
Location: Shanghai Fourth People's Hospital Shanghai Shanghai Municipality
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. 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.
Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18 years or older, regardless of sex, who are scheduled to undergo cerebral angiography or neurointerventional treatment through a transradial approach.
2. Adequate collateral circulation between the radial and ulnar arteries, as demonstrated by the modified Allen test or vascular ultrasound.
3. Radial artery diameter of at least 1.5 mm on preprocedural ultrasound examination.
4. Ability to understand the study procedures, willingness to participate voluntarily, and provision of written informed consent.
Exclusion Criteria:
1. 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.
2. 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.
3. Previous puncture, surgery, or trauma involving the radial artery on the intended puncture side that may have altered the local anatomy.
4. Hemodynamic instability requiring urgent hemodynamic support, including cardiogenic shock or severe hypotension.
5. Impaired consciousness, psychiatric illness, or any other condition that prevents the participant from cooperating with the study procedures or completing the required follow-up.
6. Severe coagulation abnormality, defined as an international normalized ratio greater than 1.8 or a platelet count below 80 × 10\^9/L.
Source: ClinicalTrials.gov (NCT07708532). StuddyBuddy aggregates publicly available trial information.