Echography to Predict Radial Artery Catheterization Failure (EPRAC) (EPRAC)
2026年8月2日 更新者：University Hospital, Montpellier
Ultrasound Prediction of Radial Arterial Catheterization Failure in Patients Undergoing Cardiac or Aortic Surgery: a Prospective Study
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
观察性的
注册 (实际的)
330
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Montpellier、法国、34295
- University hospital of Montpellier
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
取样方法
概率样本
研究人群
Adult who have an scheduled cardiac or aortic surgery at Montpellier University Hospital
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Failure to insert a radial artery catheter (KTA) by the nurse anesthesiologists
大体时间：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.
|
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Internal radial artery diameter
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
External radial artery diameter
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
Internal area of the radial artery
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
External area of the radial artery
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
Calcification of arterial wall (yes/no)
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
Thickness of arteria wall
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
Ratio between internal and external arteria diameter
大体时间：Day 1
|
Measured on echographic exam.
Image acquisition done by an independent nurse anesthesist (not involved in the management of the same patient).
Radial artery diameter measured on these images, later, by an anaesthesiologist-Resuscitator physician.
|
Day 1
|
|
Clinical characteristics at baseline
大体时间：Day 1
|
Age, sex, body mass index, ASA score, duration of preoperative fasting, cardiovascular risk factors, cardiovascular conditions, wrist circumference, pulse force of the radial, ulnar, and brachial arteries (no pulse / feeble pulse / normal pulse), mean arterial pressure at punction time, dose of vasopressants (ephedrine, neosynephrine, noradrenaline) at punction time
|
Day 1
|
|
Punction-related adverse events
大体时间：6 months
|
Hematoma, dissection, thrombosis, ischemia, false aneuvrysm, infection, pain.
|
6 months
|
|
Duration of arterial punction
大体时间：Day 1
|
delay between first pulse palpation and end of bandage on a functional catheter
|
Day 1
|
|
Duration of patient management
大体时间：28 days
|
duration of anaesthesia, duration of presence in surgery room, length of hospital stay
|
28 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jérôme PANIEGO、University hospital of Montpellier, Montpellier, France, 34295
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月15日
初级完成 (实际的)
2022年4月6日
研究完成 (实际的)
2022年4月11日
研究注册日期
首次提交
2021年1月25日
首先提交符合 QC 标准的
2021年1月25日
首次发布 (实际的)
2021年1月29日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月2日
最后验证
2022年10月1日
更多信息
与本研究相关的术语
其他研究编号
- RECHMPL20_0091
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不
在美国制造并从美国出口的产品
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