NCT05687370已完成不适用
Modified Dynamic Needle Tip Positioning Versus Long-Axis In-Plane Ultrasound Guided Radial Artery Cannulation in Patients With Coronary Artery Disease: A Randomized Controlled Trial
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Success rate of the radial artery cannulation at first attempt
研究概览
简要总结
Conventionally, long-axis in-plane (LA-IP), short-axis out-of-plane (SA-OOP) and dynamic needle tip positioning based on SA-OOP views are commonly used method to image the target vessel during cannulation under US guidance. A modified SA-OOP that add developing line on the ultrasonic probe improve the success rate of cannula insertion into the radial artery on the first attempt.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnostic criteria of coronary atherosclerotic heart disease according to the tenth version of international Classification of diseases(ICD-10);
- •Requires invasive arterial blood pressure monitoring;
- •New York Heart Association(NYHA) classification I, II or III;
- •The American Society of Anesthesiologists (ASA) classification I, II or III;
- •Patients older than 18 years and younger than 85 years (Adult);
- •Patients signed the informed consent before the study.
排除标准
- •Patients with hemodynamically unstable (systolic blood pressure 60 or less);
- •Patients with abnormal results of the modified Allen test;
- •Patients with ulnar artery occlusion;
- •Patients with coagulation disorders;
- •Patients with skin abnormalities such as inflammation or hematoma at the cannulation site;
- •Patients with raynaud disease and prevalent atherosclerosis;
- •Patients with history of hand or wrist trauma or surgery;
- •Patients who have undergone radial artery interventional therapy or radial artery cannulation within 3 months on the puncture side;
- •Patients with BMI more than 40 kg/m2;
- •Patients who have participated in other relevant clinical studies within 3 months.
结局指标
主要结局
Success rate of the radial artery cannulation at first attempt
时间窗: intraoperative
Successful confirmation of the arterial waveform through a pressure monitor at first attempt of the radial artery cannulation
次要结局
- Time to first puncture of the artery(Interval between skin penetration of the needle and flashback of blood, an expected average of 200 seconds)
- Time ultrasound imaging(Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, , an expected average of 100 seconds)
- Number of puncture attempts(Up to 5 times, an expected average observation time of 70 seconds)
- Time of arterial catheterization(Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average observation time of 300 seconds)
- Vascular complications in the surgery(postoperative, within 24 hours)
研究者
Meng Lv
Professor
Qianfoshan Hospital
研究点 (1)
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