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

开发 Sotair 以提高手动通气的性能并最​​大程度地减少并发症

• 批准号: 10708832
• 负责人: Prathamesh Prabhudesai
• 金额: $ 94.54万
• 依托单位: SAFEBVM CORP.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708832
• 关键词: Acute; Acute Lung Injury; Acute Respiratory Distress Syndrome; Adult; Air; Air Movements; Air Pressure; American Heart Association; Anesthesia procedures; Animals; Artificial Respiration; Aspiration Pneumonia; Award; Blood Pressure; Breathing; COVID-19 pandemic; Cadaver; Calibration; Cardiopulmonary; Caring; Chest; Clinical; Clinical Trials; Computer software; Critical Illness; Dangerousness; Data; Development; Devices; Disease; Dysbarism; Emergency Situation; Engineering; Ensure; Family suidae; Feedback; Future; Gases; Grant; Guidelines; Hemorrhagic Shock; Hospitals; Human; Injury; Institutional Review Boards; Insufflation; Intubation; Legal patent; Life; Lung; Lung Compliance; Manuals; Masks; Measurement; Mechanical Ventilators; Mechanical ventilation; Modeling; Monitor; Operating Rooms; Oxygen; Patient Care; Patients; Patients' Rooms; Pattern; Performance; Periodicity; Phase; Pneumothorax; Production; Provider; Pulmonary Inflammation; Qualifying; Quality Control; Quality of Care; Randomized, Controlled Trials; Resistance; Respiratory distress; Safety; Series; Small Business Innovation Research Grant; Stomach; System; Techniques; Technology; Testing; Tidal Volume; Time; Tissues; Treatment Cost; Tube; United States National Institutes of Health; Vent; Ventilator; Volutrauma; Vomiting; Work; aspirate; clinically relevant; commercialization; cost; design; efficacy evaluation; efficacy study; experience; haptics; improved; improved outcome; innovation; manufacture; mortality; next generation; porcine model; pressure; prevent; primary outcome; prototype; response; secondary outcome; sensor; software development; trial design; ventilation

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.

抽象的 袋阀口罩（BVM）复苏器是紧急气道管理和人造的金标准 未适当呼吸的患者的呼吸。但是，BVM的有据可查的问题是 无论提供商的资格和经验如何 危险的并发症，例如胃不足。胃不足会导致氧气递送减少 进行组织，引起呕吐和抽吸。患者随后可以发展出肺炎，其中 死亡率高达70％。随后，发生攻击性肺炎的患者甚至可以 发展急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）。那是解决问题的解决方案 使用BVM的不安全的手动通风，以及它们可能引起的昂贵和危险的并发症 - 迫切需要。为了应对这些问题，SafeBVM正在开发Sotair™系列产品，A 连接到标准BVM复苏器并防止危险高压的设备集 手动通风期间经常发生的流速和气流量。提出的设备 将通过集成流量阻滞和压力释放阀来控制流速。它将提供触觉和 对提供商的视听反馈，以调整其通风技术以确保安全，个性化的呼吸 在紧急情况下交付。在我们的NSF I阶段项目中，SafeBVM建立了设计参数 控制气流和压力以及开发的软件用于监视和测试设备。原型 还制造了Sotair成人设备的版本，并证明了它成功，一致 控制尸体模型中的气流模式。直接直接进入第二阶段的NIH将涉及工程以改善 设备，动物研究在出血性休克模型中的效率研究和一个关键的临床试验以证明 与机械呼吸机相比，非效率。这将通过以下三个目标来完成： 1）工程/设计工作以优化下一代Sotair设备并评估性能 常用设备，例如Lucas胸部压缩设备和O_TWO智能袋，2）确定 Sotair设备在减少胃不足，抽吸，Barotrauma和改善预后的功效 出血性休克猪模型和3）在非紧急手术室（OR）患者进行临床试验 与机械通气相比，证明Sotair设备的不介绍性并防止胃 不足。 SafeBVM提出的创新将防止高压的众多并发症， 使用BVM时经常发生的流速和气流量。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。