跳至主要内容
临床试验/NCT02473588
NCT02473588Unknown不适用

Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement

University of Virginia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Pearson Correlation Coefficient

研究概览

简要总结

A group of engineers at Michigan State developed a novel waveform analysis technique ("Long Time Interval Analysis" [LTIA]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • Adult (18 years or older)
  • Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care
  • Attending anesthesiologist plans to place an intra-arterial catheter for routine care
  • Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient

排除标准

  • Minors (17 years or younger)
  • Parturient (pregnant women)
  • Cognitively impaired
  • Unable to sign informed consent form
  • Prior esophageal surgery
  • Moderate to severe aortic regurgitation
  • Mechanical cardiac support (e.g., intra-aortic balloon pump)
  • Severe, persistent arrhythmias

结局指标

主要结局

Pearson Correlation Coefficient

时间窗: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled

Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler

次要结局

未报告次要终点

研究者

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

Robert Thiele, MD

Assistant Professor

University of Virginia

研究点 (2)

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