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