Distal Versus Conventional Radial Arterial Catheterization for Arterial Waveform Stability During Arm-Tucked Robotic Urologic Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Conventional Radial Arterial Catheterization (Procedure)
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.
干预措施: Distal Radial Arterial Catheterization (Procedure)
结局指标
主要结局
Number of Participants With Clinically Significant Arterial Catheter Dysfunction Requiring Troubleshooting or Rescue Intervention
时间窗: 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.
次要结局
未报告次要终点
研究者
Tae Kyong Kim
Associate Professor
SMG-SNU Boramae Medical Center
