Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability (DRA-stability)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tae Kyong Kim
- Phone Number: 82-2-870-2519
- Email: tk99@snu.ac.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DRA-stability
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.