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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.

抽象的袋阀面罩 (BVM) 复苏器是紧急气道管理和人工呼吸的黄金标准呼吸不充分的患者的呼吸然而，BVM 的一个有据可查的问题是。无论提供者的资格和经验如何，它们经常被滥用，这可能导致胃充气等危险的并发症可能导致氧气输送减少。进入组织，导致呕吐和误吸，患者随后可能会出现吸入性肺炎。随后，吸入性肺炎的患者死亡率高达70%。发展急性肺损伤（ALI）和急性呼吸窘迫综合征（ARDS）因此，解决这个问题。使用 BVM 进行不安全的手动通气及其可能导致的昂贵且危险的并发症的原因针对这些迫切需要，SafeBVM正在开发Sotair™系列产品，一组连接到标准 BVM 复苏器并防止危险高压的设备，手动通气期间经常出现的流速和气流量。将通过集成流量阻塞和压力释放阀来控制流量它将提供触觉和压力。向提供者提供视听反馈，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用于监控和测试设备的软件原型。 Sotair Adult 版本的设备也一直在生产，并证明它成功地并且控制尸体模型中的气流模式。NIH Direct 第二阶段将涉及改进气流模式的工程。装置、失血性休克模型功效的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) 优化下一代 Sotair 设备并评估性能的工程/设计工作常用的设备如LUCAS胸外按压设备和O_two智能包，2）确定 Sotair 装置在减少胃充气、误吸、气压伤和改善预后方面的功效失血性休克猪模型，以及 3) 在非急诊手术室 (OR) 患者中进行临床试验证明 Sotair 装置与机械通气相比的非劣性并预防胃病 SafeBVM 提出的创新将防止高压引起的众多并发症，使用 BVM 时经常出现的流量和气流量将成功。开发 Sotair™ 系列产品作为气道管理一线护理的实践标准。