Intrathoracic Pressure Regulator for Resuscitation

用于复苏的胸内压力调节器

• 批准号: 6999410
• 负责人: KEITH G LURIE
• 金额: $ 14.93万
• 依托单位: ADVANCED CIRCULATORY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6999410
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; biomedical equipment safety; cardiopulmonary resuscitation; cardiovascular function; clinical biomedical equipment; emergency care; evaluation /testing; hemodynamics; hemorrhagic shock; hypotension; hypovolemia; patient monitoring device; swine; thoracic pressure; trauma

DESCRIPTION (provided by applicant): Traumatic injury remains the number one cause of death for Americans between 1 and 44 years of age. The economic consequences of trauma related injuries are estimated at over 44 billion dollars in direct costs and over 400 billion dollars per year in productive life years. While most patients survive after arrival to the hospital, rapid and effective methods for improving hemodynamics after traumatic injury are urgently needed to reduce mortality rates from traumatic injury. This Phase 1 application is focused on a novel non-invasive device called the intrathoracic pressure regulator (ITPR), designed to enhance circulation in non-breathing hypotensive patients. The ITPR is designed to "buy time" before fluid resuscitation or more definitive care is available. Building upon the development of the inspiratory impedance threshold device (ITD), designed and demonstrated by the applicants to increase survival rates in patients in cardiac arrest and to increase blood pressure in hypotensive patients who are able to breathe spontaneously, the ITPR is a non-invasive intrathoracic pressure device that rapidly increases circulation and blood pressure in severely hypotensive patients. The ITPR attaches to the patient's airway, generates a small but continuous negative intrathoracic vacuum and thereby immediately increases blood pressure by drawing more venous blood back into the heart when not providing intermittent positive pressure ventilation. Simultaneously this device lowers intracranial pressure. Preliminary animal studies with the ITPR demonstrate that mean arterial pressures as well as coronary and cerebral perfusion pressures are rapidly increased with application of the ITPR. This Phase 1 investigation proposes to a) improve the safety and efficacy of the ITPR by a) determining the optimal vacuum needed to improve circulation, b) making and evaluating bioengineering design changes in the current prototype and c) demonstrating proof of concept by assessing neurologically intact survival rates and pulmonary complication rates with and without the ITPR in a porcine model of hemorrhagic shock. If successful, Phase 2 studies will address the potential clinical efficacy of the ITPR in patients in hemorrhagic shock. Use of the ITPR is expected to significantly increase patient resuscitation rates, based upon the improvement in blood flow to the heart and brain observed in animal studies. If a significant clinical benefit is demonstrated, the ITPR would become a standard piece of resuscitation equipment for hypotensive patients with traumatic injury and other causes of hypovolemic hypotension.

描述（由申请人提供）： 创伤性伤害仍然是1至44岁的美国人死亡的第一大原因。与创伤有关的伤害的经济后果估计直接成本超过440亿美元，生产寿命年度超过4000亿美元。虽然大多数患者在到达医院后生存，但迫切需要在造成创伤性损伤的死亡率降低死亡率后，快速有效地改善血液动力学的方法。该第1阶段的应用集中在一种称为胸腔压力调节器（ITPR）的新型非侵入性装置上，旨在增强非呼吸低血压患者的循环。 ITPR旨在在流体复苏或提供更明确的护理之前“购买时间”。基于申请人设计和证明的灵感阻抗阈值设备（ITD）的发展，以提高心脏骤停患者的存活率，并增加能够自发呼吸的降压患者的血压，ITPR是一种无创intrantransoracic的胸腔内压力装置，可快速增加循环和血液压力的患者的血压。 ITPR附着在患者的气道上，产生一个小但连续的负阴性真空吸尘器，从而在不提供间歇性的正压通风时立即通过将更多的静脉血液恢复到心脏中，从而立即增加血压。同时，该设备降低了颅内压。 ITPR的初步动物研究表明，随着ITPR的应用，平均动脉压以及冠状动脉和脑灌注压力会迅速增加。 This Phase 1 investigation proposes to a) improve the safety and efficacy of the ITPR by a) determining the optimal vacuum needed to improve circulation, b) making and evaluating bioengineering design changes in the current prototype and c) demonstrating proof of concept by assessing neurologically intact survival rates and pulmonary complication rates with and without the ITPR in a porcine model of hemorrhagic shock.如果成功，第2阶段的研究将解决ITPR在出血性休克患者中的潜在临床功效。根据动物研究中观察到的血液流动到心脏和大脑的改善，ITPR的使用预计将显着提高患者复苏率。如果证明了重大的临床益处，ITPR将成为造成外伤性损伤和其他造成低血肿低血压的低血压患者的标准复苏设备。