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临床试验/NCT00924482
NCT00924482已完成2 期

Impedance Cardiography: Clinical Evaluation of Endotracheal Cardiac Output Monitor (ECOM)

University of California, San Francisco0 个研究点目标入组 261 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
261
主要终点
Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements

研究概览

简要总结

  1. Compare measurements of cardiac output derived from electrical measurements from electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to those made from a pulmonary artery thermodilution catheter.
  2. Establish the safety and efficacy of the ECOM system.

详细描述

Introduction: Cardiac output is a key physiological parameter. Unfortunately, it is often difficult to measure without using invasive techniques with associated risk. The pulmonary artery catheter has, since its introduction, been considered the gold standard for the measurement of cardiac output in man. Unfortunately, pulmonary artery catheters have been associated with serious complications.1,2 Thoracic electrical bio-impedance (TEB) has been suggested as a possible non-invasive technique for the measurement of cardiac output. The accuracy and reliability of TEB has been evaluated multiple times with some studies demonstrating good correlation with thermodilution3-7 and others with poor correlation.6,8-15. TEB is not reliable in patients after cardiopulmonary bypass8,9, kidney transplants11, congestive heart failure16, pulmonary edema14, sepsis12, pregnancy15, abdominal surgery11,17, or critical illness13,14.

One of the limitations of TEB is the signal to noise ratio. Commonly TEB systems use an alternating current (1 - 4 ma at 20-100 Khz) applied to the skin and have little control over the percentage of current passing through the vascular structures in the chest. Changes in the electrical impedance of the lungs with respiration change the percentage of the total current passing through blood containing structures. Finally, treating all of the blood containing structures in the chest as a single impedance to be measured, does not allow separation of the signal into its various components. A technique which stabilizes the percentage of current delivered to the target structure and records the electrical impedance signals directly from that target structure improves the accuracy and reliability of impedance based measurement of cardiac output.

The Endotracheal Cardiac Output Monitor (ECOM) is a system which records the voltages produced by a current (2 ma 100 Khz) delivered to the tracheal mucosa by electrodes on an endotracheal tube. The proximity of the ascending aorta and trachea allows the design of a device that can optimize the current delivery and signal recording from impedance changes in the ascending aorta. This study will test the accuracy and efficacy of the ECOM system in anesthetized patients.

Significance: A simple, inexpensive, continuous, non-invasive, accurate, reproducible method of measuring cardiac output in patients would reduce the need for pulmonary artery catheter measurements of cardiac output. Such a technique would allow the rapid diagnosis and treatment of hemodynamic instability in the critically ill patient. The maintenance of cardiac output is essential for the prevention of end organ injury which results in morbidity and mortality. A technique that accurately measured cardiac output would greatly assist the management of the critically ill patient.

Methods:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
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 cardiac surgery which would routinely require:
  • an endotracheal tube
  • pulmonary artery 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 Impedance and Thermodilution Cardiac Output Measurements

时间窗: perioperative period

Correlation measured via Linear regression between thermodilution and ECOM, included as r\^2 coefficient. Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient. ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely).

次要结局

  • Safety of Device Measured by Number of Participants With Adverse Events(perioperative period)

研究者

申办方类型
Other
责任方
Sponsor

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