RAPID, ROBUST AND AUTOMATED CONTINUOUS CARDIAC OUTPUT

快速、稳健且自动的连续心输出量

• 批准号: 2775452
• 负责人: GREGORY T MARTIN
• 金额: $ 35.59万
• 依托单位: THERMAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-15 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2775452
• 关键词: biomedical equipment development; body temperature; calorimetry; cardiac output; computer program /software; heart catheterization; patient monitoring device; swine; thermal blood flow measurement

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.

心输出量 (CO) 是心脏的基本性能指标。最近的进展允许自动热稀释测量 CO，每 1-5 分钟更新一次，但这些更新受到先前数据的严重影响，因此扭曲、延迟和衰减了源自流量突然变化的信号。已经开发出一种热噪声降低技术，该技术允许以比每分钟一次更频繁的独立更新来测量 CO，并允许在基线血液温度变化期间监测 CO，这是干预的结果。 I 期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），并且测量速度更快（>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。还将开发独立的临床微处理器控制的 CCO 仪器，以及用于收集、分析和数据显示的必要软件和算法。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、更新速度以及在显着热噪声条件下测量流量的能力。 TTI CCO 能够提供独立于先前数据的频繁测量，对于心血管血流动力学变化的不稳定患者的管理将大有裨益。拟议的商业应用：预计全球销售的许多 TDCO 导管（每年超过 200 万）最终将被 CCO 导管取代。 TTI CCO 方法提供的快速、独立的测量以及热噪声抑制预计将提高 CCO 的接受度，并开辟当前可用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 适度增加的成本是合理的。