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临床试验/NCT03117673
NCT03117673Unknown不适用

Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: a Pilot Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
39
试验地点
1
主要终点
RVSP calculated from TEE measurements

研究概览

简要总结

Transesophageal echocardiography (TEE) plays an important role in intraoperative monitoring and can be used to estimate pulmonary artery pressures. An excellent correlation between right ventricular systolic pressure (RVSP) measured by right heart catheterization (RHC) and simultaneously estimated by transthoracic echocardiography is reported and also implemented into the current guidelines for the echocardiographic assessment of the right heart in adults by the American Society of Echocardiography. So far there are no studies evaluating RVSP measured by transesophageal echocardiography (TEE) and recommendations are unclear which transesophageal view is the best for calculation.

We want to assess if there is a difference in the systolic pulmonary artery pressure measured invasively with a pulmonary artery catheter (PAC) and the calculated right ventricular systolic pressure (RVSP) using transesophageal echocardiography (TEE) in 3 different views: ME 4Ch, ME RV inflow-outflow, ME modified bicaval.

详细描述

Transesophageal echocardiography (TEE) plays an important role in intraoperative monitoring and can be used to estimate pulmonary artery pressures. In 1984 Yock et al. were the first ones who reported an excellent correlation between right ventricular systolic pressure (RVSP) measured by right heart catheterization (RHC) and simultaneously estimated by transthoracic echocardiography. Later this was confirmed by several authors (3-6) and therefore also implemented into the current guidelines for the echocardiographic assessment of the right heart in adults by the American Society of Echocardiography. So far there are no studies evaluating RVSP measured by transesophageal echocardiography (TEE) and recommendations are unclear which transesophageal view is the best for calculation. More recent studies evaluated the accuracy of echocardiography in patients with pulmonary hypertension and mostly revealed only a moderate to weak correlation between echocardiography and right heart catheter mesurements. One study evaluated patients with severe tricuspid regurgitation and pulmonary hypertension and showed that pulmonary artery systolic pressure is frequently overestimated in this population. Fewer studies reported a good correlation between these two methods. There is also evidence that additional indices and paramenters can help to assess pulmonry hypertension more precisely with echocardiography, such as TAPSE, Tei index or LV eccentric index. These parameters seem to be abnormal in presence of pulmonary hypertension.

Study objectives (Hypothesis)

We want to assess if there is a difference in the systolic pulmonary artery pressure measured invasively with a pulmonary artery catheter (PAC) and the calculated right ventricular systolic pressure (RVSP) using transesophageal echocardiography (TEE) in 3 different views: ME 4Ch, ME RV inflow-outflow, ME modified bicaval.

Study design

Prospective, single-center, observer-blinded, diagnostic test accuracy study.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective cardiac surgery in general anaesthesia
  • Transesophageal echocardiography (TEE) indicated
  • Pulmonary artery catheter (PAC) indicated

排除标准

  • Age < 18 years
  • Atrial fibrillation
  • Declined informed consent

结局指标

主要结局

RVSP calculated from TEE measurements

时间窗: during routine transesophageal echocardiography examination

Bias and precision of RVSP calculated from TEE measurements as compared to measured systolic pulmonary artery pressure with PAC

次要结局

  • Differences in bias and precision between patients with normal, and elevated mean PAP, and those with severe TI(during routine transesophageal echocardiography examination)

研究者

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

Ulrike Weber

Ass.Prof.Dr.

Medical University of Vienna

研究点 (1)

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