跳至主要内容
临床试验/NCT03405623
NCT03405623已完成不适用

Randomized Trial of Ultrasound-guided Radial Artery Cannulation Using Dynamic Short Axis Versus Conventional Long-axis In-plane View in Cardiac Surgery Patients.

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2018年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
Success rate of the radial artery cannulation at first attempt

研究概览

简要总结

When performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP) method is newly introduced by one group of investigators who conducted a related study using vascular phantom model.

In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.

DNTP has not been compared to conventional imaging methods. The aim of this trial is to see the effect of DNTP on success rate of the radial artery cannulation at the first attempt, compared to the conventional LAX.

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
Triple (Participant, Investigator, 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

入选标准

  • Elective cardiovascular surgery where RA catheterization is newly required.

排除标准

  • skin infection or trauma
  • Bilateral arteriovenous fistula for dialysis
  • Severe peripheral vascular disease
  • Severe arteriosclerosis or arterial atheroma
  • Raynaud disease
  • Patients on ECMO or IABP support
  • Morbid obesity
  • Profound coagulopathy
  • Negative results of modified Allen's test

研究组 & 干预措施

Dynamic needle tip positioning

Active Comparator

In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an hyper-echoic point, the practitioner (a) moves the US probe proximally a bit, and (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.

干预措施: Dynamic needle tip positioning under ultrasound-guidance (Procedure)

Conventional long-axis

Active Comparator

干预措施: Conventional long-axis view (Procedure)

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 between skin puncture to confirmation of the arterial waveform through a pressure monitoring device.(During the cannulation procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Kyong Kim

Clinical Assistant Professor

Seoul National University Hospital

研究点 (2)

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