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Biplanar Handheld Ultrasound for Transradial Artery Puncture

13 luglio 2026 aggiornato da: Yibin Fang, Shanghai Fourth People's Hospital Tongji University

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

152

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200435
        • Shanghai Fourth People's Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Biplanar handheld ultrasound system
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.
Comparatore attivo: 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.
Dispositivo: Conventional high-frequency linear-array ultrasound system
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
First-attempt success rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean total number of puncture attempts required for successful radial artery cannulation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Fourth People's Hospital Tongji University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Stimato)

30 aprile 2027

Completamento dello studio (Stimato)

30 aprile 2027

Date di iscrizione allo studio

Primo inviato

13 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

16 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2026027-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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