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Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability (DRA-stability)

2 de agosto de 2026 atualizado por: Tae Kyong Kim, Seoul National University Hospital

Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability During Arm-Tucked Robotic Urologic Surgery: A Prospective Randomized Controlled Study

During robot-assisted urologic surgery, both arms are often placed alongside the body and covered by surgical drapes. This position can make the arterial catheter difficult to access during surgery. A conventional radial arterial catheter placed at the wrist may become compressed or bent because of wrist position or arm fixation, which can cause an inaccurate or dampened arterial blood pressure waveform. A distal radial arterial catheter may be less affected by wrist movement or pressure on the forearm.

This single-center randomized study will include 70 adults undergoing robot-assisted urologic surgery under general anesthesia who require invasive arterial blood pressure monitoring. Participants will be randomly assigned in a 1:1 ratio to ultrasound-guided conventional radial arterial catheterization at the wrist or distal radial arterial catheterization near the anatomical snuffbox or back of the hand.

The main purpose of the study is to determine whether distal radial arterial catheterization reduces clinically significant arterial catheter dysfunction requiring troubleshooting or rescue treatment while the arms are tucked. The study will also compare catheter insertion success, first-attempt success, insertion time, episodes of dampened or lost arterial pressure waveforms, difficulty obtaining arterial blood samples, need for catheter replacement or another arterial access site, and catheter-related complications.

Visão geral do estudo

Descrição detalhada

Invasive arterial blood pressure monitoring allows continuous assessment of blood pressure and repeated arterial blood sampling during general anesthesia. The conventional radial artery at the wrist is commonly used for arterial catheterization. However, wrist flexion or extension, arm fixation, surgical drapes, and external pressure may compress or bend the catheter and result in damping or loss of the arterial pressure waveform.

During robot-assisted urologic surgery, both arms are commonly tucked alongside the body. After surgical positioning and robot docking, direct access to the arterial catheter may be limited. A distal radial arterial catheter placed near the anatomical snuffbox or on the dorsal aspect of the hand is located distal to the wrist joint and may therefore be less affected by wrist position and forearm compression.

This is a single-center, prospective, randomized, open-label, superiority study. Seventy adult participants undergoing robot-assisted urologic surgery under general anesthesia and requiring invasive arterial pressure monitoring will be randomly assigned in a 1:1 ratio to conventional radial arterial catheterization or distal radial arterial catheterization. Randomization will be performed using a computer-generated block randomization sequence after written informed consent and confirmation of eligibility.

Both procedures will be performed under ultrasound guidance using standard sterile technique and a standard 20-gauge or 22-gauge over-the-needle arterial catheter. In the conventional radial artery group, the catheter will be inserted at the wrist, approximately 1 to 2 cm proximal to the radial styloid. In the distal radial artery group, the catheter will be inserted into a suitable segment of the distal radial artery in the anatomical snuffbox or dorsal hand. Up to three skin puncture attempts will be permitted. If catheter insertion is unsuccessful or further attempts are considered inappropriate, rescue arterial catheterization will be performed according to standard clinical practice.

Routine prophylactic wrist-extension splints will not be applied in either group. Additional fixation, repositioning, catheter replacement, or other corrective measures may be performed at any time if required for reliable blood pressure monitoring or participant safety. The observation period will begin after both arms have been tucked and will continue until robot undocking or release of the arm-tucked position.

The primary objective is to compare the occurrence of clinically significant arterial catheter dysfunction requiring troubleshooting or rescue intervention during the observation period. Such dysfunction may include persistent damping or loss of the arterial waveform, clinically relevant disagreement between invasive and noninvasive blood pressure measurements, inability to aspirate blood, suspected catheter kinking or compression, or the need for interventions such as flushing, line assessment, dressing adjustment, hand or wrist repositioning, arm untucking, splint application, catheter replacement, or alternative arterial access.

Secondary assessments will include overall and first-attempt insertion success, insertion time, number and duration of waveform damping or loss episodes, difficulty with arterial blood aspiration, need for rescue catheterization, and the procedural burden of maintaining reliable arterial pressure monitoring. Safety assessments will include bleeding, hematoma, vasospasm, infection, pain or sensory symptoms, signs of hand ischemia, suspected radial artery occlusion, catheter replacement, and other unexpected adverse events. Clinically necessary treatment will not be delayed or restricted by study procedures.

Tipo de estudo

Intervencional

Inscrição (Estimado)

70

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Tae Kyong Kim
  • Número de telefone: 82-2-870-2519
  • E-mail: tk99@snu.ac.kr

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Adults aged 19 years or older
  • Scheduled to undergo robot-assisted urologic surgery under general anesthesia
  • Scheduled to have both arms positioned alongside the body in an arm-tucked position during surgery
  • Considered by the attending anesthesiologist to require intraoperative invasive arterial blood pressure monitoring
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Refusal to participate or inability to provide written informed consent
  • Emergency surgery
  • Pregnancy or breastfeeding
  • Lack of decision-making capacity requiring consent from a legally authorized representative
  • Presence of an arteriovenous fistula for dialysis or unsuitable bilateral radial artery access
  • Infection, burn, trauma, surgical scar, or severe skin lesion at the intended puncture site
  • Suspected hand perfusion impairment, including radial artery occlusion, absent radial pulse, severe peripheral vascular disease, or Raynaud phenomenon
  • Severe coagulopathy or uncorrected bleeding tendency for which radial arterial catheterization is considered inappropriate
  • Any condition for which the attending anesthesiologist considers study participation inappropriate for participant safety

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Conventional Radial Artery Group
Participants assigned to this arm will undergo ultrasound-guided conventional radial arterial catheterization at the wrist, approximately 1 to 2 cm proximal to the radial styloid.
Ultrasound-guided arterial catheterization will be performed at the conventional radial artery at the wrist, approximately 1 to 2 cm proximal to the radial styloid, using standard sterile technique. A standard sterile disposable 20-gauge or 22-gauge over-the-needle arterial catheter will be selected according to vessel diameter, depth, and clinical judgment. Up to three skin puncture attempts will be permitted. After insertion, the catheter will be connected to the pressure monitoring system, zeroed at the level of the right atrium, assessed using a fast-flush test, and secured with a transparent dressing and tape. Routine prophylactic wrist-extension splinting will not be applied. Rescue catheterization may be performed according to standard clinical practice if insertion fails or reliable arterial pressure monitoring cannot be maintained.
Experimental: Distal Radial Artery Group
Participants assigned to this arm will undergo ultrasound-guided distal radial arterial catheterization at a suitable segment of the distal radial artery in the anatomical snuffbox or dorsal aspect of the hand.
Ultrasound-guided arterial catheterization will be performed at a suitable segment of the distal radial artery in the anatomical snuffbox or dorsal aspect of the hand using standard sterile technique. The insertion site will be selected according to vessel diameter, depth, and course on ultrasound. A standard sterile disposable 20-gauge or 22-gauge over-the-needle arterial catheter will be used. Up to three skin puncture attempts will be permitted. After insertion, the catheter will be connected to the pressure monitoring system, zeroed at the level of the right atrium, assessed using a fast-flush test, and secured with a transparent dressing and tape. Routine prophylactic wrist-extension splinting will not be applied. Rescue catheterization may be performed according to standard clinical practice if insertion fails or reliable arterial pressure monitoring cannot be maintained.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention
Prazo: From completion of bilateral arm tucking until robot undocking or release of the arm-tucked position during surgery
Number of participants experiencing at least one clinically significant arterial catheter dysfunction event during the arm-tucked observation period. An event is defined as: arterial pressure waveform damping or loss lasting at least 20 seconds; a difference of at least 20 mmHg between invasive and noninvasive systolic blood pressure measured simultaneously or within 1 minute when catheter dysfunction requires assessment or treatment; inability or clear resistance when aspirating blood; suspected catheter kinking or external compression requiring assessment; or the need for flushing, pressure line assessment, dressing adjustment, hand or wrist repositioning, wrist splint application, arm untucking, catheter replacement, or alternative arterial access. Transient changes during planned blood sampling, fast-flush testing, zeroing, or transducer adjustment are counted only if they persist for at least 20 seconds afterward or require additional intervention.
From completion of bilateral arm tucking until robot undocking or release of the arm-tucked position during surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de agosto de 2026

Conclusão Primária (Estimado)

31 de julho de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2026

Primeira postagem (Real)

28 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • DRA-stability

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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