Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability

NCT07732296 | Not Yet Recruiting

• 1 other identifier: DRA-stability
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Arterial Catheter Dysfunction; Intraoperative Arterial Blood Pressure Monitoring

Keywords

Distal Radial Artery; Radial Arterial Catheterization; Arterial Waveform Damping

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention

  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

Study Arms (2)

Conventional Radial Artery Group

ACTIVE COMPARATOR

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.

Procedure: Conventional Radial Arterial Catheterization

Distal Radial Artery Group

EXPERIMENTAL

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.

Procedure: Distal Radial Arterial Catheterization

Interventions

Conventional Radial Arterial Catheterization PROCEDURE

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.

Conventional Radial Artery Group

Distal Radial Arterial Catheterization PROCEDURE

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.

Distal Radial Artery Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Central Study Contacts

Tae Kyong Kim

CONTACT

82-2-870-2519; tk99@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07