The Impact of Modified Site for Radial Artery Cannulation on the Stability of Arterial Blood Pressure Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- Incidence of arterial catheter dysfunction
研究概览
简要总结
Invasive arterial blood pressure (IABP) monitoring is critical for perioperative and critically ill patients, yet traditional radial artery cannulation near the wrist joint is prone to catheter dysfunction (e.g., kinking, occlusion) due to positional changes, compromising accuracy and patient safety. This trial hypothesizes that modifying the cannulation site to 1.5-2.5 cm proximal to the radial styloid process may enhance catheter stability.
详细描述
Methods and analysis:This is a prospective, parallel-group, randomized, controlled, analyst-blinded trial. A total of 486 participants (231 per group, adjusted for 5% dropout) will be enrolled. Eligible patients (18-75 years, ASA physical status I-III, requiring elective surgery with radial artery cannulation) will be randomized 1:1 to the modified group (1.5-2.5 cm proximal to the radial styloid process) or the conventional group (traditional site). The primary outcome is the incidence of arterial catheter dysfunction (defined by criteria such as blood sampling difficulty, position-dependent waveform, or improved waveform post-square wave test). Secondary outcomes include frequency of catheter dysfunction, damping abnormality rate, first-puncture success rate, number of arterial punctures,arterial cannulation time, complication incidence, and blood pressure measurement differences.
Sample size calculation:This trial utilized a superiority test for sample size calculation. In the 100-case preliminary experiment results, the incidence rate of abnormal arterial catheter function was 30% in the control group and 12% in the modified group. With a predefined superiority margin Δ of -6% (actual observed Δ of -18%), using a type I error rate (α) of 0.025 and statistical power (1-β) of 0.90, statistical calculations determined that 231 participants per group (totaling 462) would be required to detect this difference in a two-sided test. Considering a 5% dropout rate among study subjects, the final planned sample size was adjusted to 486 cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-75 years of age undergoing elective surgery who require radial artery cannulation;
- •Patients positioned in supine, lithotomy, or other face-up surgical postures;
- •American Society of Anesthesiologists (ASA) physical status classification: Grades I to III.
排除标准
- •Abnormal results from the modified Allen test;
- •Patients with a history of radial artery cannulation within the past 3 months, or with infection/trauma at or adjacent to the puncture site;
- •Coagulopathy or hypercoagulable state;
- •Patients undergoing anticoagulant therapy;
- •Comorbid vascular diseases (e.g., vasculitis);
- •Patients undergoing surgical procedures involving the same anatomic region;
- •Preoperative hemodynamic instability (including patients already on vasoactive medications, or with atrial fibrillation, atrial flutter, atrioventricular block of grade II or higher, multifocal ventricular premature beats, or ventricular premature beats with R-on-T phenomenon);
- •Patients lacking legal capacity to sign informed consent.
研究组 & 干预措施
1.5-2.5 cm proximal to the radial styloid process
The ultrasound-guided radial artery puncture site is1.5-2.5 cm proximal to the radial styloid process
干预措施: The puncture site is 1.5-2.5 cm proximal to the radial styloid process (Procedure)
traditional site
The ultrasound-guided radial artery puncture site is level with the radial styloid process and where the radial artery pulse is most prominent
干预措施: traditional site (Procedure)
结局指标
主要结局
Incidence of arterial catheter dysfunction
时间窗: during the period of catheter indwelling
(a) difficulty in blood sampling: When drawing arterial blood samples for blood gas analysis, the sample cannot be aspirated smoothly through the arterial pressure monitoring line, necessitating repeated flushing of the line to obtain an adequate sample; or arterial catheter occlusion occurs and a new arterial pressure monitoring pathway must be established based on surgical or anesthetic requirements; (b) position-dependent waveform or flushing: repositioning of the arterial catheter or wrist is required to obtain a satisfactory arterial waveform, or smooth flushing can only be achieved following such repositioning. (c) improved waveform post-square wave test: after a square wave test (conducted every 30 minutes or when the arterial waveform becomes flat), the arterial waveform shows significant improvement compared to its pre-flush state.
次要结局
- Frequency of arterial catheter dysfunction(during the period of catheter indwelling)
- Damping abnormality rate and frequency(during the period of catheter indwelling)
- First-puncture success rate(From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes)
- Number of arterial punctures(From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes)
- Arterial Cannulation Time(From the start of arterial puncture until successful arterial catheter placement or abandonment of the arterial catheter placement procedure,up to 10 minutes)
- Complication incidence(from the time of the puncture onset until the time of every day after arterial puncture (at 1-day, 2-day, 3-day)
- Difference in IABP before and after square wave test.(during the period of catheter indwelling)
- Difference between IABP and NIBP(during the period of catheter indwelling)
研究者
SanQing Jin
professor
Sixth Affiliated Hospital, Sun Yat-sen University