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临床试验/NCT03264183
NCT03264183已完成不适用

Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年9月18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
126
试验地点
1
主要终点
Tricuspid annular plane systolic excursion (TAPSE)

研究概览

简要总结

Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.

Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.

详细描述

Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Adult patients undergoing elective cardiac surgery requiring TEE

排除标准

  • Patient who do not wish to consent
  • Patients with contraindications to TEE
  • Urgent or emergent cardiac surgery
  • Patients with preexisting open chest
  • Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
  • Non-English speaking subjects
  • Cognitively impaired adults
  • Pregnancy

结局指标

主要结局

Tricuspid annular plane systolic excursion (TAPSE)

时间窗: Immediately following the induction of anesthesia and TEE probe placement

Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.

Right ventricular fractional area change (FAC)

时间窗: Immediately following the induction of anesthesia and TEE probe placement

Right ventricular fractional area change (FAC) will be measured using both TTE and TEE.

RV free wall longitudinal strain

时间窗: Immediately following the induction of anesthesia and TEE probe placement

RV free wall longitudinal strain will be measured using both TTE and TEE.

Right ventricular index of myocardial performance (RIMP)

时间窗: Immediately following the induction of anesthesia and TEE probe placement

Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.

RV annular systolic velocity (S')

时间窗: Immediately following the induction of anesthesia and TEE probe placement

RV annular systolic velocity (S') will be measured using both TTE and TEE.

次要结局

  • Ease of obtaining appropriate TEE measures of right ventricular function(Within 15 minutes following anesthesia induction)
  • Define values for normal right ventricular free wall strain(Through study completion, an estimate of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shayne Michael Roberts

Assistant Professor

Milton S. Hershey Medical Center

研究点 (1)

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