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临床试验/NCT04806932
NCT04806932Unknown不适用

Comparison of the Modified Approach and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in Intensive Care Unit(ICU) Hypotensive Patients: a Randomized Controlled Study.

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年4月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
102
试验地点
1
主要终点
First-pass success

研究概览

简要总结

Radial artery cannulation can be performed under short-axis ultrasound guidance. However, the first puncture success rate was low in patients with hypotensive patients. Compared with the conventional approach, the modified approach combined the ultrasonic location system with a dynamic needle tip positioning technique. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided radial artery cannulation in hypotensive ICU patients.

详细描述

Hypotensive patients in the intensive care unit may have extremely unstable hemodynamics. Blood pressure is the most important outcome in the diagnosis and treatment of shock. Vasopressor drugs are often required to maintain blood pressure in addition to fluid infusion. Noninvasive blood pressure measurement is unable to meet the clinical requirements. It is necessary to establish an invasive blood pressure monitoring method as soon as possible that can observe the real-time pressure. Radial artery cannulation has become the most commonly used due to its superficial location and less severe complication. However, radial artery cannulation is difficult to achieve in hypotensive patients due to weak radial artery pulsation, small arterial diameter, and peripheral vasospasm as blood flow is directed toward central vessels.

Some studies have shown that ultrasound-guided cannulation is more successful than the palpation technique. However, the success rate is largely dependent on the ultrasound operator's experience and skills. The operator requires good hand-eye coordination, technical skills, and some experience to overcome this shortcoming of ultrasound, which limits the advantages of ultrasound-guided vascular puncture, especially for operators with insufficient experience. There are 2 basic approaches in needling techniques: short-axis out-of-plane(SA-OOP) and long-axis in-plane(LA-IP) techniques.

In-plane technology requires the operator to be very skilled at ultrasound technology, which is more dependent on experience and can be difficult for novices to master; on the other hand, given that the long axis is subject to slice-thickness artifacts, due to the measurable thickness of the ultrasound beam itself, the cannula in the long axis appears to be in the same plane as the extremely small radial artery, even when the cannula has not been successfully inserted into the artery. Therefore, we prefer the out-of-plane technique.

The short-axis view has the advantages of providing better visualization of the surrounding structures and easier imaging which is convenient for novices to master. The procedure of radial artery puncture can be divided into 3 steps. The first step is to locate the puncture site, the second step is the puncture, and the last step entails the insertion of the cannula into the radial artery.

The first step is particularly important because appropriate localization facilitates the success of the puncture and insertion. The first difficulty encountered during radial artery puncture is the exact positioning of the puncture point. Ultrasound with developing lines guided by dynamic ultrasound has achieved a good effect in patients without hypotension. In the group with the modified technique, we use the developing line to locate the puncture site.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients were randomized to the conventional Approach (CA) or modified Approach (MA) group in a 1:1 ratio using a computerized system. The allocation process was intensively managed by an allocation group using sequentially numbered containers and the allocation result was concealed until it was implemented. When a patient was eligible, the investigator informed the allocation group to get intervention group allocated to the patient: CA orMA group. Because of feasibility issues, operators were not blinded to the assignment.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in intensive care units;
  • The need for invasive hemodynamic monitoring (arterial blood pressure and cardiac output monitoring);
  • The need for frequent blood sampling (arterial blood gas analysis and general laboratory evaluation);
  • Vasopressor therapy;

排除标准

  • a negative Allen test;
  • ulnar artery occlusion;
  • prevalent atherosclerosis;
  • a blocked or embolized target vessel determined by ultrasound assessment;
  • Raynaud disease;
  • infection near the radial artery puncture site;

结局指标

主要结局

First-pass success

时间窗: approximately 3 minutes

successful catheterization on the first attempt

次要结局

  • Posterior wall puncture(within 10 minutes)
  • Overall success(within 10 minutes)
  • The cannulation time(within 10 minutes)
  • the number of attempts(within 10 minutes)
  • Complication rate(Day 1)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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