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: 10547254
• 负责人: Prathamesh Prabhudesai
• 金额: $ 105.43万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547254
• 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; Aspirate substance; Aspiration Pneumonia; Award; Blood Pressure; Breathing; COVID-19 pandemic; Cadaver; 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; Gold; Grant; Guidelines; Hemorrhagic Shock; Hospitals; Human; Injury; Institutional Review Boards; Insufflation; Lead; 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; Quality Control; Quality of Care; Randomized Controlled Trials; Resistance; Respiratory distress; Resuscitation; 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; base; clinically relevant; commercialization; cost; design; efficacy study; engineering design; experience; haptics; improved; improved outcome; innovation; 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.

摘要 袋式气门面罩(BVM)是急诊呼吸道管理和人工智能的黄金标准。 呼吸不充分的病人的呼吸。然而，BVMS的一个有充分记录的问题是 它们经常被滥用，而不考虑提供者的资格和经验，这可能导致 危险的并发症，如胃气肿。胃内充气会导致氧气输送减少 到组织，引起呕吐和吸入。患者随后会患上吸入性肺炎，这种肺炎有 死亡率高达70%。随后，患上吸入性肺炎的患者甚至可以 出现急性肺损伤(ALI)和急性呼吸窘迫综合征(ARDS)。因此，这个问题的解决方案 使用BVMS进行不安全的手动通风-以及它们可能导致的昂贵和危险的并发症-是 急需之物。为了回应这些担忧，SafeBVM正在开发Sotair™系列产品， 一套连接到标准BVM复苏器并防止危险的高压的设备， 手动通风过程中经常出现的流量和风量。建议的设备 将通过集成流量阻挡和压力释放阀来控制流量。它将提供触觉和 向供应商提供视听反馈，以调整他们的通风技术，以确保安全、个性化的呼吸 在紧急情况下交付。在我们的NSF第一阶段项目中，SafeBVM建立了设计参数 他们控制气流和压力，并开发了监控和测试该设备的软件。原型机 Sotair成人设备的版本也被制造出来，并证明了它成功和一致地 控制身体模型中的气流模式。NIH直接进入第二阶段将涉及工程设计，以改善 装置，失血性休克模型的有效性的动物研究，以及一项关键的临床试验 与机械呼吸机相比并不逊色。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器件并评估性能 常用的设备如Lucas胸压装置和O_Two智能手袋，2)确定 Sotair装置在减少胃充气、误吸、气压伤和改善预后中的作用 失血性休克猪模型，以及3)在非急诊手术室(OR)患者中进行临床试验 演示Sotair装置与机械通气相比的非劣势并预防胃病 打气。SafeBVM提出的创新将防止高压带来的众多并发症， 使用BVMS时经常出现的流速和风量。这项技术将成功地 开发索泰尔™系列产品，作为呼吸道管理一线护理的实践标准。