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临床试验/NCT04730479
NCT04730479已完成不适用

Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2021年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
330
试验地点
1
主要终点
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists

研究概览

简要总结

In patients undergoing cardiac or aortic surgery, the placement of a radial KTA is sometimes difficult, the purpose of this study is to do an ultrasound in order to evaluate the diagnostic values of the internal diameter of the radial artery to predict the failure to install the radial KTA.

详细描述

The Arterial Catheter (KTA) enables continuous measurement of invasive blood pressure in patients with accurate and reliable hemodynamic monitoring. Radial Artery Catheterization is the currently recommended placement site.

In patients undergoing cardiac or aortic surgery, placement of a radial KTA is sometimes difficult, with a failure rate of around 15%. It is also a source of local complications and prolongation of the anesthetic duration.

There is no predictive diagnostic test for failed radial KTA placement in anesthesia.

Accurately predicting the failure of radial catheterization by echography will, in the future, make it possible to offer "at risk" patients an immediate catheterization in an other site as for example brachial site.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Aged from 18 years old
  • •Be operated for a scheduled cardiac or aortic surgery
  • •Be able to complete all the visits and follow the study procedures
  • •Subjects must be covered by public health insurance

排除标准

  • •Patients protected by law or Absence of signed informed consent
  • •Emergency Surgery Patient
  • •Patient already with an arterial catheter
  • •Patient with Radial Arterial Catheter Contraindication
  • •Radial arterial catheter placed by an anesthesiologist nurse student

结局指标

主要结局

Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists

时间窗: Day 1

Failure to insert the radial KTA by the nurse anesthesiologist defined as follows: ≥ 3 punctures (by the nurse anesthetist) or need to change of doctor operator (nurse anesthesiologist to Anesthesiologist - Resuscitator) or change of puncture site (radial to radial contralateral or other site). All professionals involved are blinded to the echographic measures of the radial artery.

次要结局

  • Internal radial artery diameter(Day 1)
  • Clinical characteristics at baseline(Day 1)
  • Internal area of the radial artery(Day 1)
  • External area of the radial artery(Day 1)
  • Calcification of arterial wall (yes/no)(Day 1)
  • Punction-related adverse events(6 months)
  • Ratio between internal and external arteria diameter(Day 1)
  • Duration of arterial punction(Day 1)
  • Duration of patient management(28 days)
  • External radial artery diameter(Day 1)
  • Thickness of arteria wall(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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