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临床试验/NCT01714258
NCT01714258已完成不适用

A Non Invasive Estimation of Cardiac Output in Mechanically Ventilated Patients: a Prolonged Expiration Method

Campus Bio-Medico University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
A non invasive method to estimate cardiac output in mechanically ventilated surgery based on prolonged expiration and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution.

研究概览

简要总结

The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and pulmonary artery thermodilution , are both invasive methods, requiring the use of central venous catheter and Swan-Ganz catheter, respectively.

With the aim to reduce the risks for the patient, a big research effort has been made to investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The method is based on prolonged expiration, and relies on measurement of gas concentrations and flow rate. Investigators designed, realized, and characterized a system to induce passive prolonged expirations when connected to the patient circuit.

CO is then calculated using an algorithm based a modified version of the Fick equation and the results are compared with the ones obtained by thermodilution.

Several advantages can be introduced by the prolonged expiration technique: non-invasive measurement, easy implementation, independency from operator ability among others.

详细描述

This prospective trial was designed to assess the performance of a non invasive method to estimate cardiac output in mechanically ventilated cardiac surgery patients and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution. The pulmonary blood flow (PBF), which is the volume of blood that actively participates in the gas exchange per unit of time, is the directly estimated variable that this technique employ to calculate cardiac output. The method investigators studied is theoretically based on the application of an algorithm which derives from a modified version of the Fick equation in two different phases; the former involves measurements during the steady state, whilst the second starts when a sudden perturbation into the carbon dioxide (CO2) elimination process is introduced. The algorithms investigated in this work requires the analysis of the expired gas content during both normal breathing and prolonged expiration, providing a non-invasive estimation of the artero-venous content of CO2, and consequently allows the calculation of PBF according to the Fick method. At this purpose, a metabolic monitor was used; it sampled gas from the "Y" piece of the mechanical ventilator's breathing circuit through a suction pump. In order to obtain the prolonged expiration, a pneumatic system, with an ad hoc designed orifice resistance (5 cmH2O•L-1•min),has been made and experimentally characterized to adapt the breathing circuit to this application. Experimental data of CO2 and O2 concentrations were recorded and processed after the measurement session thanks to an ad hoc developed LabView application. This application performs the following tasks: it converts the gas fractions into partial pressures, segments the trends of partial pressures, executes the data-reduction and, after obtaining the values of venous carbon dioxide tension (PvCO2) and arterial carbon dioxide tension (PaCO2) obtained, it calculates the CO value using the above mentioned algorithms.

The values calculated with non invasive method showed good agreement with ones obtained by thermodilution and a precision comparable to those of other minimally invasive techniques.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Postoperative cardiac surgery patients mechanically ventilated after surgery

排除标准

  • Patients who were hemodynamically unstable requiring high doses of vasoactive medications, fluids or colloidal solutions to maintain their pressure
  • Patients who require inspired oxygen concentration higher than 60%.

研究组 & 干预措施

non invasive cardiac output measure

Experimental

non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients 20 times, throughout a period of about 45 min

干预措施: cardiac output measurement (Procedure)

结局指标

主要结局

A non invasive method to estimate cardiac output in mechanically ventilated surgery based on prolonged expiration and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution.

时间窗: within the first day after surgery

To obtain cardiac output for each patient,throughout a period of about 45 min, thermodilution was executed 10 times, and prolonged expiration 20 times.

次要结局

未报告次要终点

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimiliano Carassiti

professor

Campus Bio-Medico University

研究点 (2)

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