Biplanar Handheld Ultrasound for Transradial Artery Puncture
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Čína, 200435
- Shanghai Fourth People's Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: TUOREN Biplanar Handheld Ultrasound Guidance
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.
|
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.
|
|
Aktivní komparátor: Conventional Ultrasound Guidance
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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
First-attempt success rate
Časové okno: 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.
|
During the puncture procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean total number of puncture attempts required for successful radial artery cannulation
Časové okno: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
|
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.
|
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
Časové okno: From initial needle-to-skin contact until confirmation of successful radial artery cannulation during the index procedure
|
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.
|
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
Časové okno: From confirmation of successful radial artery cannulation until completion of catheter fixation and dressing during the index procedure
|
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.
|
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
Časové okno: From the first puncture attempt until confirmation of successful radial artery cannulation during the index procedure
|
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.
|
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
Časové okno: Within 1 minute before the first puncture attempt of the index procedure
|
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.
|
Within 1 minute before the first puncture attempt of the index procedure
|
|
Mean diastolic blood pressure before the first puncture attempt
Časové okno: Within 1 minute before the first puncture attempt of the index procedure
|
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.
|
Within 1 minute before the first puncture attempt of the index procedure
|
|
Mean heart rate before the first puncture attempt
Časové okno: Within 1 minute before the first puncture attempt of the index procedure
|
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.
|
Within 1 minute before the first puncture attempt of the index procedure
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2026027-001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Biplanar handheld ultrasound system
-
National Taiwan University HospitalNational Taiwan University Hospital Bei-Hu BranchNáborÚspěšná kanylaceTchaj-wan