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

2 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Tae Kyong Kim
  • Telefoonnummer: 82-2-870-2519
  • E-mail: tk99@snu.ac.kr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

5 augustus 2026

Primaire voltooiing (Geschat)

31 juli 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

23 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • DRA-stability

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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