跳至主要内容
临床试验/NCT04858126
NCT04858126已完成不适用

Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter

ECOM Medical, Inc.2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月1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
110
试验地点
2
主要终点
Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements

研究概览

简要总结

This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.

详细描述

This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System (Edwards LifeSciences).

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

  • Patients able to give informed consent.
  • Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter.

排除标准

  • Patients who do not speak English.
  • Patients not competent to give informed consent.

结局指标

主要结局

Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements

时间窗: 6 months.

Correlation via linear regression between thermal dilution and ECOM Plus included as an "R" to coefficient. Cardiac output measured by thermal dilution and impedance cardiography. Management of the patients using standard thermal dilution derived CO measurement only. The ECOM Plus measurement output are for research purposes only and not to be used in the management of the patient. ECOM Plus impedance cardiography measured in the ICU when routine thermal dilution CO measurements are made. Continued impedance measurements until tracheal extubation.

次要结局

未报告次要终点

研究者

发起方
ECOM Medical, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验