RAPID, ROBUST AND AUTOMATED CONTINUOUS CARDIAC OUTPUT

心输出量(CO)是衡量心脏功能的基本指标。最近的进展允许每1-5分钟更新一次CO的自动热稀释测量，但这些更新很大程度上受到先前数据的影响，因此会扭曲、延迟和衰减来自流量突然变化的信号。开发了一种热降噪技术，它允许以比每分钟一次更频繁的独立更新来测量CO，并允许在作为干预结果的基线血温变化期间监测CO。第一阶段的体外和体内研究表明，该方法比Baxter Vigilance CCO仪器更准确、更精确(2倍)，测量速度更快(&gt；7倍)。在第二阶段，我们将开发一种适合批量生产导管的工艺。还将开发一台独立的临床微处理器控制的CCO仪器，以及收集、分析和数据显示所需的软件和算法。整个系统将在一系列猪实验中进行广泛的测试，以测试准确性、更新速度和在显著热噪声条件下测量流量的能力。TTI CCO能够提供与先前数据无关的频繁测量，这将对心血管血流动力学可变的不稳定患者的管理大有裨益。建议的商业应用：预计全球销售的许多TDCO导管(每年200万英镑)最终将被CCO导管取代。TTI CCO方法提供的快速和独立的测量以及热噪声抑制有望提高CCO的接受度，并开辟目前现有技术无法达到的其他应用和市场。持续心输出量的额外好处，预计将证明CCO装置相对于传统TDCO的适度增加成本是合理的。

Cardiac output (CO) is the fundamental performance measure of the heart. Recent advances have permitted automatic thermodilution measurement of CO with updates every 1-5 minutes, but these updates are heavily weighted by prior data and thus distort, delay and attenuate the signal which derives from sudden changes in flow. A thermal noise reduction technique has been developed which allows the measurement of CO with independent updates more frequent than once a minute and permits monitoring of CO during changes in baseline blood temperature which are consequences of interventions. Phase I in vitro and in vivo studies have shown that this method is more accurate, more precise (2-fold), and bas greater measurement speed (>7 times) than the Baxter Vigilance CCO instrument. In Phase ll, we will develop a process appropriate to manufacture catheters in production volumes. A stand-alone clinical microprocessor controlled CCO instrument will also be developed, as will the necessary software and algorithms for the collection, analysis and data display. The entire system will be extensively tested in a series of porcine experiments for accuracy, update speed and the ability to measure flow under conditions of significant thermal noise. The ability of the TTI CCO to provide frequent measurements, independent of prior data, will be of great benefit in the management of unstable patients with variable cardiovascular hemodynamics. PROPOSED COMMERCIAL APPLICATION: It is anticipated that many of the TDCO catheters sold world-wide (>2 million annually) will eventually be replaced by CCO catheters. The rapid and independent measurements as well as the thermal noise rejection provided by the TTI CCO method is expected to increase the acceptance of CCO and open up other applications and markets unreachable by the currently available techniques. The added benefit of continuous cardiac output, is expected to justify the modest added cost of the CCO device over traditional TDCO.