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Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart

2020年1月20日更新者：Maciej Piwoda、Uniwersytecki Szpital Kliniczny w Opolu

Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart With Passive Leg Raise and Intravenous Fluid Infusion

Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid responsiveness. However, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. Vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. The common carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. It is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.

研究概览

地位

撤销

条件

干预/治疗

诊断测试：fluid responsiveness assessment

研究类型

观察性的

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

波兰
- Opolskie
  - Opole、Opolskie、波兰、45-372
    - Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

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

有资格学习的性别

全部

取样方法

概率样本

研究人群

Mechanically ventilated patients admitted to critical care unit.

描述

Inclusion Criteria:

mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment

Exclusion Criteria:

contraindication for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload)
contraindication for PLR test (e.g. after trauma)
lack of possibility to examine the carotid arteries
bilateral carotid surgery in the past
bilateral anatomical defects of the carotid arteries
unstable cardiac rhythm (e.g. atrial fibrillation)

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

团体/队列数

队列和干预

团体/队列	干预/治疗
Acute circulatory failure Mechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment.	诊断测试：fluid responsiveness assessment During the procedure, the investigator will be imaging one of the carotid arteries with ultrasound. In expiratory phase, four sets of three video loops will be recorded: before and after PLR and then before and after fluid challenge. There also will be noted hemodynamic parameters measured with PiCCO monitor. The fluid challenge is defined as administration of 500ml of crystalloid in less than 10 minutes. Later, another investigator, who will be blinded to other data, will measure the maximal and minimal diameter of CCA in each loop. The measurements will be averaged and eventually two values (maximal an minimal) from each set will be obtained. 其他名称：流体挑战 passive leg raise

团体/队列

干预/治疗

Acute circulatory failure

Mechanically ventilated patients with acute circulatory failure, monitored with PiCCO method, who need fluid responsiveness assessment.

诊断测试：fluid responsiveness assessment

During the procedure, the investigator will be imaging one of the carotid arteries with ultrasound. In expiratory phase, four sets of three video loops will be recorded: before and after PLR and then before and after fluid challenge. There also will be noted hemodynamic parameters measured with PiCCO monitor. The fluid challenge is defined as administration of 500ml of crystalloid in less than 10 minutes. Later, another investigator, who will be blinded to other data, will measure the maximal and minimal diameter of CCA in each loop. The measurements will be averaged and eventually two values (maximal an minimal) from each set will be obtained.

其他名称：

流体挑战
passive leg raise

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
Changes in the diameter of the common carotid artery 大体时间：1 minute after PLR test and 1 minute after fluid challenge	The diameter will be measured with ultrasound	1 minute after PLR test and 1 minute after fluid challenge

次要结果测量

结果测量	措施说明	大体时间
Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness. 大体时间：1 minute after PLR test and 1 minute after fluid challenge	The changes in the diameter of CCA will be compared with the changes in cardiac output measured with PiCCO method.	1 minute after PLR test and 1 minute after fluid challenge

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。

赞助

Uniwersytecki Szpital Kliniczny w Opolu

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 (预期的)

2019年6月1日

初级完成 (预期的)

2020年10月1日

研究完成 (预期的)

2020年10月1日

研究注册日期

首次提交

2018年1月21日

首先提交符合 QC 标准的

2018年1月25日

首次发布 (实际的)

2018年1月26日

研究记录更新

最后更新发布 (实际的)

2020年1月23日

上次提交的符合 QC 标准的更新

2020年1月20日

最后验证

2020年1月1日

fluid responsiveness assessment的临床试验

University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR)

完全的

改善农村地区成年人心力衰竭结局的教育计划 (REMOTE-HF)

心力衰竭，充血

美国
Nanogen, Inc.
Centers for Disease Control and Prevention

暂停

液体快速流感检测的前瞻性评估

流感

美国, 香港
Burst Biologics

未知

Burst Biologics 足踝登记处

脚和脚踝疾病 | 踝关节融合术、截骨术

美国
Burst Biologics

未知

Burst Biologics 脊柱融合登记处

退行性椎间盘疾病 | 脊柱炎 | 椎管狭窄 | 腰椎滑脱 | 椎间盘突出

美国
Nanogen, Inc.

暂停

Fluid Rapid Influenza 与 BinaxNOW Influenza A & B 的比较

流感

美国
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...
Opera CRO, a TIGERMED Group Company

完全的

儿科中的透明质酸和牙龈炎

牙龈炎
Konya Beyhekim Training and Research Hospital

招聘中

颈源性头痛，认知功能障碍

颈源性头痛

火鸡
Guerbet

完全的

评估 Lipiodol® Ultra Fluid 在血管栓塞期间与手术胶的结合。 (In-Live)

动静脉畸形 | 血管内皮瘤 | 血管肉瘤 | 先天性血管瘤

印度
Ain Shams University

尚未招聘

谵妄与心力衰竭

心脏衰竭 | 精神错乱状态

埃及

Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart