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临床试验/NCT03088943
NCT03088943已完成不适用

Assessment of Diastolic Function Using Intraoperative Transesophageal Echocardiography: Comparison of Mitral Annular Plane Velocity and Systolic Excursion Measured by Tissue Doppler Imaging vs. Speckle-Tracking

Patrick F Wouters, MD PhD2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
mean early diastolic mitral annular plane velocity (E')

研究概览

简要总结

This project aims at exploring measures of diastolic function perioperatively.

详细描述

Perioperative echocardiographic quantification of myocardial function is of great importance in patient management and is increasingly being recommended intraoperatively in spite of some unresolved or under-explored issues. One such issue is the perioperative measurement of diastolic function. Diastolic dysfunction and diastolic heart failure - or as commonly referred to "heart failure with preserved ejection fraction (HFpEF)" - is responsible for some 35 to 50% of heart failures. Intraoperative measurements of diastolic function have a prognostic and management relevance for patients undergoing both cardiac and non-cardiac surgery. However, even recent guidelines on intraoperative transesophageal echocardiography (TEE) have neglected this topic, with the exception of the most recent, which briefly alluded to the role TEE can play in assessing diastolic function, but without addressing the issue of which measurements or views to use.

The clinically prevalent echocardiographic view for assessment of intraoperative diastolic function by tissue Doppler imaging (TDI) is the midesophageal 4-chamber (ME 4C) TEE view. This view, which looks at the heart from the left atrium, is the standard view for evaluating intraoperative global cardiac performance. However, the Doppler angle for assessing diastolic performance is generally much greater than 20° and, as Doppler techniques are known to be angle dependent based on the Doppler equation, using this view may relevantly underestimate TDI velocities. Views from the apex of the heart (i.e. both the deep transgastric long axis view [dTG LAX] TEE view as well as the apical 4-chamber [AP 4C] transthoracic echocardiography (TTE) view) have a cosine angle towards the mitral annular plane excursion near zero, thereby allowing valid measurements according to the Doppler equation. However, TDI velocities are often - and potentially erroneously - reported from the ME 4C TEE view.

The objective of this project is to address a number of important clinical topics regarding diastolic dysfunction in TEE.

Two main objectives will be examined:

  • Assess whether or not tissue doppler imaging (TDI) measurements of mitral annular plane velocities and systolic excursion in the midesophageal 4-chamber TEE view (ME 4C) significantly underestimate diastolic cardiac performance compared to the deep transgastric long axis TEE view (dTG LAX) due to intrinsic misalignment of the doppler beam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Echo exams will be stored for later analysis by blinded assessors.

入排标准

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

入选标准

  • ≥18 years
  • undergoing cardiac surgery, and
  • routinely receiving TEE for the surgical procedure, independent of the study.

排除标准

  • atrial flutter or fibrillation
  • severe mitral calcification
  • cancelled surgery
  • unwilling or unable to provide consent

结局指标

主要结局

mean early diastolic mitral annular plane velocity (E')

时间窗: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

(E'lateral + E'medial)/2; by TDI and STE

次要结局

  • mean early diastolic mitral inflow velocity/mean early diastolic mitral annular plane velocities; (E/E')(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • Displacement by Mitral Annular Plane Systolic Excursion (MAPSE)(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • mean late (atrial) diastolic mitral annular plane velocity (A')(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • mean early diastolic mitral annular plane velocity/mean late (atrial) diastolic mitral annular plane velocity (E'/A')(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • Peak systolic mitral annular velocity (S')(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • Displacement by Tricuspid Annular Place Systolic Excursion (TAPSE)(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • Displacement of Tricuspid Annular Plane (by speckle-tracking software)(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • Displacement of Mitral Annular Plane (by speckle-tracking software)(immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view))
  • 3D volumes of left ventricle(immediately during echo exam while in the operating room; i.e. postinduction (TEE ME 4C view), post-CPB (TEE ME 4C view))
  • 3D volumes of right ventricle(immediately during echo exam while in the operating room; i.e. postinduction (TEE ME 4C view), post-CPB (TEE ME 4C view))

研究者

发起方
Patrick F Wouters, MD PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Patrick F Wouters, MD PhD

Head of Anesthesiology

University Hospital, Ghent

研究点 (2)

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