High Efficiency Hypo/Hyperthermia System

高效低温/高温系统

• 批准号: 6582508
• 负责人: William J. Ohley
• 金额: $ 10万
• 依托单位: LIFE RECOVERY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6582508
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; body temperature; cardiopulmonary resuscitation; cardiovascular disorder therapy; heart arrest; hemodynamics; induced hypothermia; swine; technology /technique development

DESCRIPTION (provided by applicant): Sudden cardiac arrest remains a serious public health issue. Approximately 350,000 individuals are stricken in the U.S. annually, with overall survival rates on the order of only 5%. Even with the immediate availability of the most advanced care currently available, a survival rate of 25% appears to be the best-case scenario. Improved therapies to deal with this situation are clearly needed. Prior studies have shown that moderate hypothermia (approximately 3-5 C degrees) provided during and after cardiac arrest can reduce the level of damage to vital organs, including the brain. However, conventional noninvasive means that are available for cooling (such as water-filled cooling blankets and cool air-emitting coverings) are too slow for optimal treatment. Furthermore, they are not well suited to being used during administration of cardiopulmonary resuscitation (CPR). Life Recovery Systems (LRS) intends to develop an advanced, noninvasive Therapeutic Hypothermia Device (THD) for rapid and controlled reduction of core body temperature. To achieve this goal, this system will combine the use of components, which will provide highly efficient and regulated cooling of the skin. The THD will be designed in such a manner that it can be used in combination with advanced forms of CPR, so that cooling can be efficiently delivered even while the subject is in a state of cardiac arrest. Initial swine tests of a THD prototype have shown that it is capable of reducing body core temperature approximately twice as quickly as can be done by covering the animal with packed ice. The THD cooling rate was approximately fifty times greater than that reported in recent clinical testing in which a cooled air system was applied to patients. LRS plans to initially conduct tests using a physical model of the body to optimize the design of the THD. It will then conduct animal studies (50 Kg swine) to further optimize the system, to evaluate the repeatability of the cooling which can be delivered, to compare the performance of the device to other cooling methods (such as standard cooling blankets), and to evaluate the ability of the THD to operate simultaneously with the delivery of CPR. During cooling experiments, temperatures will be monitored in the animal's pulmonary artery, auditory canal, and skin. In addition, EKG, blood pressures, and other key physiologic parameters will be monitored. The tests described in this proposal will be followed in the future by other tests (in both animals and humans) investigating the ability of the THD, in combination with other measures such as CPR, to improve neurologically intact survival following cardiac arrest. Long term, LRS believes that the THD has the potential to significantly increase the chances of neurologically intact survival following cardiac arrest. It also plans to evaluate the effectiveness of the THD in the treatment of other conditions, such as stroke.

描述（由申请人提供）：心脏骤停仍然是一个严重的公共卫生问题。美国每年约有 350,000 人患病，总体存活率仅为 5%。即使可以立即获得目前最先进的护理，25% 的生存率似乎也是最好的情况。显然需要改进的疗法来应对这种情况。先前的研究表明，心脏骤停期间和之后提供的中度低温（约 3-5 摄氏度）可以减少对包括大脑在内的重要器官的损害程度。然而，可用于冷却的传统非侵入性方法（例如充满水的冷却毯和冷空气排放覆盖物）对于最佳治疗来说太慢。此外，它们不太适合在心肺复苏（CPR）期间使用。 Life Recovery Systems (LRS) 打算开发一种先进的非侵入性低温治疗装置 (THD)，用于快速、可控地降低核心体温。为了实现这一目标，该系统将结合使用多个组件，为皮肤提供高效且可调节的冷却。 THD 的设计方式使其可以与先进形式的心肺复苏结合使用，以便即使在受试者处于心脏骤停状态时也可以有效地提供冷却。 THD 原型的初步猪测试表明，它降低身体核心温度的速度大约是用冰块覆盖动物的两倍。 THD 冷却速率比最近对患者应用冷却空气系统的临床测试中报告的冷却速率大约高出五十倍。 LRS 计划首先使用人体物理模型进行测试，以优化 THD 的设计。然后，它将进行动物研究（50 公斤猪），以进一步优化系统，评估可提供的冷却的可重复性，将该设备的性能与其他冷却方法（例如标准冷却毯）进行比较，并评估 THD 与心肺复苏同时进行的能力。在冷却实验期间，将监测动物的肺动脉、耳道和皮肤的温度。此外，还将监测心电图、血压和其他关键生理参数。在本提案中描述的测试之后，未来将进行其他测试（在动物和人类中），研究 THD 与 CPR 等其他措施相结合的能力，以提高心脏骤停后神经系统完整的生存率。从长远来看，LRS 认为 THD 有可能显着增加心脏骤停后神经系统完整的生存机会。它还计划评估 THD 在治疗中风等其他疾病方面的有效性。