Development of Sotair for Improving Performance and Minimizing Complications of Manual Ventilation

摘要 气囊阀面罩（BVM）复苏器是紧急气道管理和人工呼吸的金标准。 呼吸不足的患者的呼吸。然而，BVM的一个有据可查的问题是， 他们经常被滥用，无论提供者的资格和经验如何，这可能导致 危险的并发症，如胃充气。胃吹气可导致氧气输送减少 导致呕吐和误吸患者随后可发展为吸入性肺炎， 死亡率高达70%随后，患有吸入性肺炎的患者甚至可以 发生急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）。因此，问题的解决方案 BVM的不安全手动通气-以及它们可能导致的昂贵和危险的并发症-是 迫切需要。为了应对这些问题，SafeBVM正在开发Sotair™系列产品， 一套连接到标准BVM复苏器并防止危险高压的设备， 流速和气流体积，这在手动通气过程中经常发生。申报器械 将通过集成流动阻断和压力释放阀来控制流速。它将提供触觉和 提供视听反馈，以调整他们的通气技术，以确保安全，个性化的呼吸， 在紧急情况下提供。在我们的NSF第一阶段项目中，SafeBVM确定了设计参数 控制气流和压力，并开发了监控和测试该设备的软件。一个原型 还制造了Sotair成人器械版本，并证明其成功且一致地 控制尸体模型中的气流模式。这NIH直接到第二阶段将涉及工程，以改善 设备，在失血性休克模型中的有效性动物研究，以及证明 与机械呼吸机相比的非劣效性。这将通过以下三个目标来实现： 1)工程/设计工作，以优化下一代Sotair设备并评估性能， 常用的设备，如LUCAS胸外按压设备和O_two智能袋，2）确定 Sotair装置在减少胃充气、误吸、气压伤和改善预后中的有效性 出血性休克猪模型，和3）在非急诊手术室（OR）患者中进行临床试验 证明Sotair器械与机械通气相比的非劣效性，并防止胃 吹气SafeBVM提出的创新将防止高压造成的众多并发症， 流速和气流体积，这些都是使用BVM时经常出现的问题。这项技术将成功 开发Sotair™系列产品，作为气道管理一线护理的标准实践。

Abstract Bag valve mask (BVM) resuscitators are the gold standard of emergency airway management and artificial respiration for patients who are not breathing adequately. However, a well-documented problem with BVMs is that they are often misused, regardless of the qualifications and experience of the provider, which can lead to dangerous complications such as gastric insufflation. Gastric insufflation can lead to decreased oxygen delivery to tissue, causing vomiting and aspiration. Patients can subsequently develop aspiration pneumonia, which has a mortality rate as high as 70%. Subsequently, patients who have developed aspiration pneumonia can even develop acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). Thus, a solution to the problem of unsafe manual ventilation with BVMs—and the costly and dangerous complications they can cause—is urgently needed. In response to these concerns, SafeBVM is developing the Sotair™ series of products, a set of devices that attach to standard BVM resuscitators and prevent the dangerously high pressure, flow rates, and volumes of airflow that frequently occur during manual ventilation. The proposed device will control flow rates by integrating flow blocking and pressure release valves. It will provide haptic and audiovisual feedback to providers to adjust their ventilation techniques to ensure safe, personalized breaths are delivered during emergencies. During our NSF Phase I project, SafeBVM established the design parameters that control airflow and pressure and developed software for monitoring and testing the device. A prototype version of the Sotair Adult device was also manufactured and demonstrated that it successfully and consistently controls airflow patterns in a cadaver model. This NIH Direct to Phase II will involve engineering to improve the device, animal studies of efficacy in a model of hemorrhagic shock, and a pivotal clinical trial to demonstrate non-inferiority compared to a mechanical ventilator. This will be accomplished through the following three aims: 1) Engineering/design work to optimize a next-generation Sotair device and evaluate performance against commonly used devices like the LUCAS chest compression device and O_two smart bag, 2) Determine the efficacy of Sotair device in reducing gastric insufflation, aspiration, barotrauma, and improving outcomes in a hemorrhagic shock porcine model, and 3) Conduct a clinical trial in non-emergency operating room (OR) patients to demonstrate non-inferiority of Sotair device compared to mechanical ventilation and prevent gastric insufflation. SafeBVM’s proposed innovation will prevent the numerous complications from the high pressure, flow rates, and volumes of airflow that frequently occur when using BVMs. This technology will successfully develop the Sotair™ series of products as a standard of practice for first-line care in airway management.