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临床试验/NCT01080495
NCT01080495Unknown4 期

Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
33
试验地点
1
主要终点
left ventricular function

研究概览

简要总结

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.

Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC).

Radial strain is a new parameter to asses left ventricular function. The investigators want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.

详细描述

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.

Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC). These parameters can be assessed in the transgastric mid papillary short axis view (TG SAX) to quantify left ventricular systolic function. Limitations of these methods are the experience of the investigator - the more experienced the investigator the more reliable and reproducible the data are, load dependency of these methods and the geometrical assumption of a one-dimensional measurement for assessment of a three-dimensional contracting left ventricle. Therefore, LV-function will either be over- or underestimated by influence of segmental wall motion abnormalities or by missing them.

Radial strain allows reliable and reproducible evaluation of left ventricular function and also allows assessment of myocardial deformation from representative segments of each wall of the left ventricle. Myocardial strain is described as the relative deformation of a myocardial fiber, normalized to its original length:L1-L0/L0(%). Strain is positive (radial thickening) if L1>L0 and negative (longitudinal shortening and circumferential thinning) if L1<L0. Radial strain is sensitive to changes in contractility and less influenced by loading conditions which occur frequently during anaesthesia in a wide spectrum of non-cardiac surgery as a result of blood loss or loss of hemodynamic autoregulation due to anesthetic drugs.

Therefore we want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.

Study hypothesis

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
  • •Age above 18 years
  • •Signed informed consent

排除标准

  • •No patient's consent
  • •Subjects not able to understand study procedures
  • •Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
  • •Medical history of any kind of heart disease, dyspnea or angina pectoris
  • •Hypertension (medically treated)
  • •Atrial fibrillation

研究组 & 干预措施

TEE (transesophageal echcardiography)

Other

all patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated

干预措施: TEE (transesophageal echocardiography) (Procedure)

结局指标

主要结局

left ventricular function

时间窗: 3min during TEE

for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)

次要结局

  • left ventricular function during changes in loading conditions(3min during TEE)

研究者

申办方类型
Other

研究点 (1)

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