Pilot Human Study Using Transnasal Cooling on Cardiac Arrest Subjects

 描述（由申请人提供）：该项目将导致创建一种名为CoolStat的临床级产品，该产品将能够在心脏骤停后快速安全地冷却大脑和身体。CoolStat旨在由EMS人员启动，以在停搏后开始早期冷却，这已被证明可提高存活率和神经结局。作为整个项目的一部分，我们将（1）创建用于人体试验的临床级CoolStat产品;（2）获得FDA批准，将该产品用于心脏骤停试验研究（通过IDE）;（3）完成心脏骤停患者的试验研究，以测量安全性和冷却效果。目前为患者提供早期冷却的技术是无效的，依赖于某种形式的主动冷却，无论是通过冰袋、冷盐水还是蒸发流体。我们的方法是新颖的，因为我们正在利用一个生理过程，触发身体冷却自己。没有主动冷却系统或蒸发化学品。我们的冷却方法仅使用干燥的环境空气，我们将其吹入鼻道，然后从口中提取潮湿的空气。这建立了一个蒸发冷却热交换，有效地将能量和热量从身体中抽出，在10分钟内以约1摄氏度的速度冷却大脑。该项目将 是我们已经完成的先前赠款工作的延伸，包括临床前和人类可行性测试。我们将分三个阶段完成这项拟议项目。在第一年，我们将从产品的台式原型过渡到生产约50个临床级设备。我们还将从FDA获得IDE以进行人体研究。在第二年，我们将与我们的战略合作伙伴Zoll Medical合作，Zoll Medical是患者体温管理领域的领先商业公司。Zoll已同意与我们合作，以便更好地评估我们冷却技术的优势。此外，人体研究将在Zoll预先批准的5个研究中心进行。在第三年，我们将完成人体研究，分析和发表结果，并希望过渡到与Zoll的关键研究。这项工作将验证一种诱导低温的新方法，该方法可以在院外心脏骤停以及其他大脑和心脏缺血性损伤的治疗过程中轻松部署。它将证明早期冷却的临床价值，并有望成为护理标准。最终，我们计划利用该资助计划创建一系列冷却产品，可用于心脏骤停，ST段抬高心肌梗死，中风和其他潜在适应症。

 DESCRIPTION (provided by applicant): This project will result in the creation of a clinical-grade product called the CoolStat that will be able to quickly and safely cool the brain and body after cardiac arrest. The CoolStat is designed to be initiated by EMS personnel to start early cooling post arrest, which has been shown to improve survival rates and neurological outcomes. As part of this overall project, we will (1) create the clinical-grade CoolStat product for use in human trial; (2) obtain FDA approval to use the product in a pilot cardiac arrest study (via an IDE); and (3) complete the pilot study in cardiac arrest victims to measure safety and cooling efficacy. Current techniques to provide early cooling to patients are not effective, relying on some form of active cooling, whether by ice packs, cold saline or evaporative fluids. Our approach is novel in that we are harnessing a physiologic process that triggers the body to cool itself. There are no active cooling systems or evaporative chemicals. Our cooling method uses only dry, ambient air that we blow into the nasal track and then extract the moisturized air from the mouth. This sets up an evaporating cooling heat exchange, which effectively pulls energy and heat out of the body, cooling the brain at a rate of about 1 C in 10 minutes. This project will be an extension of previous grant work we have completed, including pre-clinical and feasibility testing in humans. We will complete this proposed project in three sequential stages. In Year 1, we will transition from a bench-top prototype of the product to making about 50 clinical-grade devices. We will also obtain an IDE from the FDA to run the human study. In Year 2, we will implement the human study by working with our strategic partner, Zoll Medical, a leading commercial company in the field of patient temperature management. Zoll has agreed to partner with us to allow them to better assess the benefit of our cooling technology. Tentatively, the human study will be conducted at 5 sites that have been pre-approved by Zoll. In Year 3, we will finish the human study, analyze and publish the results, and hopefully transition into a pivotal study with Zoll. This work will validate a new method for inducing hypothermia that can be easily deployed during treatment of out-of-hospital cardiac arrest, as well as other ischemic injuries to the brain and the heart. It will prove the clinical value of early cooling and hopefully become a standard of care. Ultimately, we plan to leverage this grant program into the creation of a family of cooling products that can be used for cardiac arrest, ST elevated myocardial infarction, stroke and other potential indications.