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临床试验/NCT01806467
NCT01806467已完成不适用

Continuous Thermodilution, Transpulmonary Thermodilution and Pressure Recording Analytical Method for Cardiac Output Measurement During Hemodynamic Instability: a Prospective Clinical Study

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Blant-Altman test and coefficient of error of Cardiac Output measured with PRAM towards that measured with thermodilution

研究概览

简要总结

Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.

详细描述

Hemodynamic monitoring is important in critically ill patients. It is often used to assess a cardiovascular derangements, to help diagnosing the causes and to monitor the response to therapy.

Pulmonary thermodilution (ThD) is still considered the gold standard reference method for cardiac output (CO) measurement [1]. Its invasiveness, however, often limits or delays its application [2, 3]. In the last decades new less invasive hemodynamic monitoring systems have been developed. The majority of such new devices allows for continuous monitoring of CO and other hemodynamic variables [4].

Among the various less invasive techniques, the PiCCO (Pulse-induced Contour Cardiac Output) relies on the concept of the "pulse contour methodology" for providing beat-to-beat CO assessment. This method needs transpulmonary ThD calibration. This is a well validated dilution technique [5]. Another minimally invasive system is the Pressure Recording Analytical Method (PRAM). Unlike other systems with pulse contour analysis, the PRAM does not need external or internal calibration factors since it analyzes the pressure waveform at a frequency of 1000 Hz and computes the patient's cardiovascular system impedance using a mathematical algorithm based on the physical theory of perturbations. It only requires a connection to a femoral or radial artery catheter for the acquisition and analysis of the arterial pressure traces [6]. This new method has been validated under different experimental and clinical settings [6-9]. Limited data are available under conditions of hemodynamic instability [10-12]. So far, its accuracy and reliability in assessing CO in hemodynamically unstable patients needs yet to be clarified.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Hemodynamic instability in:
  • septic shock
  • pneumonia
  • polytrauma
  • chronic obstructive pulmonary disease
  • heart failure
  • post operative cardiosurgical patients

排除标准

  • Atrial fibrillation
  • Pacemaker or implantable cardiac defibrillator
  • Aortic or mitral valve disease
  • Intra-aortic balloon pump

结局指标

主要结局

Blant-Altman test and coefficient of error of Cardiac Output measured with PRAM towards that measured with thermodilution

时间窗: Study Period: 9 months

Agreement between Cardiac Output measured with PRAM and cardiac output measured with thermodilution (both pulmonary and transpulmonary thermodilution) was determined by the Bland-Altman method. The precision of the measurements was given by the limits of agreement (LoA) (±1.96SD) of the mean difference of the methods compared. Upper and lower LoA were calculated as the bias ± 1.96SD. The percentage error was calculated as the LoA of the bias divided by the mean CO from two methods compared. Thirty per cent was considered an a priori criterion of interchangeability.

次要结局

未报告次要终点

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abele Donati, MD

Professor

Università Politecnica delle Marche

研究点 (1)

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