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临床试验/NCT05687370
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

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

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Meng Lv

Professor

Qianfoshan Hospital

研究点 (1)

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