Zimmermann Andreas, Kufner Christine, Hofbauer Stephan, Steinwendner Joachim, Hitzl Wolfgang, Fritsch Gerhard, Schistek Roland, Kirnbauer Michael, Pauser Gernot
Department of Anaesthesiology and Intensive Care Medicine, Paracelsus Medical University, Salzburg, Austria.
J Cardiothorac Vasc Anesth. 2008 Jun;22(3):388-93. doi: 10.1053/j.jvca.2007.11.001. Epub 2008 Jan 22.
The Vigileo/FloTrac system (software version 1.01; Edwards Lifesciences, Irvine, CA) determines cardiac output, without calibration, by analysis of the arterial pulse wave. To assess the accuracy of the Vigileo/FloTrac system, it was compared with the pulmonary artery catheter bolus thermodilution method as the current standard method. The study design was prospective and observer blinded.
A single university hospital.
Thirty elective coronary artery bypass graft surgery patients. No special interventions were done to the participants.
After approval by the ethics committee and with written informed consent, synchronized measurements using both methods were made at 7 predefined time points, intraoperatively and postoperatively, producing 192 data pairs for evaluation. The statistical evaluation was performed by using the Bland-Altman method of analysis. In addition, a +/-20% and +/-30% deviation from the pulmonary artery catheter were evaluated (20% criteria and 30% criteria). In total, 46% of measurements did not fulfill the 20% criteria; 26% were outside the 30% limits. The Bland-Altman analysis for all time points showed that 95% of all differences between both methods were within a range between -2.2 and +3.1 L/min. Regression analysis revealed low correlation values at all time points.
The described deviation from the standard must be regarded according to the user's needs. Considering the 30% limits of agreement, the Vigileo system (version 1.01) seems sufficiently accurate; applying the 20% criteria, it is not.
Vigileo/FloTrac系统（软件版本1.01；爱德华兹生命科学公司，加利福尼亚州欧文市）通过分析动脉脉搏波来测定心输出量，无需校准。为评估Vigileo/FloTrac系统的准确性，将其与作为当前标准方法的肺动脉导管团注热稀释法进行比较。研究设计为前瞻性且观察者盲法。
一家大学医院。
30例择期冠状动脉旁路移植手术患者。未对参与者进行特殊干预。
经伦理委员会批准并获得书面知情同意后，在术中及术后7个预定义时间点使用两种方法进行同步测量，产生192对数据用于评估。采用Bland-Altman分析方法进行统计学评估。此外，评估了与肺动脉导管相比±20%和±30%的偏差（20%标准和30%标准）。总体而言，46%的测量未达到20%标准；26%超出30%界限。对所有时间点的Bland-Altman分析表明，两种方法之间所有差异的95%在-2.2至+3.1 L/分钟范围内。回归分析显示所有时间点的相关值较低。
必须根据用户需求考虑所描述的与标准的偏差。考虑到30%的一致性界限，Vigileo系统（版本1.01）似乎足够准确；应用20%标准时则不然。
