Intraoperative Arterial Blood Pressure MonitoringDRA-stabilityNCT07732296
Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability
A study testing Conventional Radial Arterial Catheterization and Distal Radial Arterial Catheterization in people with Intraoperative Arterial Blood Pressure Monitoring and Arterial Catheter Dysfunction, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Intraoperative Arterial Blood Pressure Monitoring, Arterial Catheter Dysfunction, Robotic Urologic Surgery
- What is being tested?
- Conventional Radial Arterial Catheterization and Distal Radial Arterial Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraoperative Arterial Blood Pressure Monitoring, Arterial Catheter Dysfunction, Robotic Urologic Surgery
- Being tested
- Conventional Radial Arterial Catheterization, Distal Radial Arterial Catheterization
- Keywords
- Distal Radial Artery, Radial Arterial Catheterization, Arterial Waveform Damping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Radial Arterial CatheterizationProcedure or surgery
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.
Distal Radial Arterial CatheterizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Distal Radial Arterial Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From completion of bilateral arm tucking until robot undocking or release of the arm-tucked position during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start5 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Arterial Blood Pressure MonitoringStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Kyong Kim, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732296
- Sponsor's protocol ID
- DRA-stability
- Acronym
- DRA-stability
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability During Arm-Tucked Robotic Urologic Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07732296
- Acronym / sponsor ID
- DRA-stability / DRA-stability
- Conditions
- Intraoperative Arterial Blood Pressure Monitoring, Arterial Catheter Dysfunction, Robotic Urologic Surgery
- Keywords
- Distal Radial Artery, Radial Arterial Catheterization, Arterial Waveform Damping
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Radial Artery Group | Active comparator | Procedure: Conventional Radial Arterial CatheterizationParticipants 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. |
| Distal Radial Artery Group | Experimental | Procedure: Distal Radial Arterial CatheterizationParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Radial Arterial CatheterizationUltrasound-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. | Procedure or surgery | Conventional Radial Artery Group |
| Distal Radial Arterial CatheterizationUltrasound-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. | Procedure or surgery | Distal Radial Artery Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Radial Arterial Catheterization and Distal Radial Arterial Catheterization in people with Intraoperative Arterial Blood Pressure Monitoring and Arterial Catheter Dysfunction, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae Kyong Kim (82-2-870-2519, tk99@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.