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.
Public Health Relevance Statement: Narrative Bag valve mask (BVM) resuscitators are frequently misused during emergency ventilation situations, leading to increased bodily harm and complications that can increase patient mortality. SafeBVM is developing a series of products that can be attached to BVM devices to appropriately regulate the amount of airflow and pressure users deliver to patients. This technology will improve the quality of care for patients in respiratory distress and ensure BVM users are consistent in their actions to prevent under or overventilation.
Project Terms: United States National Institutes of Health; NIH; National Institutes of Health; Operating Rooms; Oxygen; O element; O2 element; Legal patent; Patents; Patients; Patients' Rooms; Periodicity; Cyclicity; Rhythmicity; Aspiration Pneumonia; Pneumothorax; pneumothorax disorder; pressure; Production; Quality Control; Artificial Respiration; Acute Respiratory Distress Syndrome; ARDS; Acute Respiratory Distress; Adult ARDS; Adult RDS; Adult Respiratory Distress Syndrome; Da Nang Lung; Shock Lung; Stiff lung; wet lung; Safety; Hemorrhagic Shock; Computer software; Software; Stomach; gastric; Family suidae; Pigs; Suidae; Swine; porcine; suid; Technology; Testing; Tidal Volume; respiratory airway volume; Time; Tissues; Body Tissues; Mechanical Ventilators; Pulmonary Ventilators; Vomiting; Emesis; Work; Treatment Cost; Ventilator; Vent; Caring; Guidelines; injuries; Injury; Tube; sensor; improved; mechanical respiratory assist; mechanically ventilated; Mechanical ventilation; Acute; Clinical; Phase; Series; Ensure; Measurement; Acute Pulmonary Injury; Acute Lung Injury; randomized control trial; Randomized, Controlled Trials; aspirate; Life; Pattern; Techniques; System; Respiratory distress; Cardiopulmonary; experience; Performance; Devices; Chest; Thorace; Thoracic; Thorax; Modeling; Quality of Care; QOC; response; software development; develop software; developing computer software; Provider; preventing; prevent; Data; Qualifying; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Development; developmental; cost; designing; design; next generation; determine efficacy; efficacy analysis; efficacy assessment; efficacy determination; efficacy examination; evaluate efficacy; examine efficacy; efficacy evaluation; Volutrauma; innovate; innovative; innovation; resistant; Resistance; clinical relevance; clinically relevant; haptics; prototype; commercialization; primary outcome; secondary outcome; IRB; IRBs; Institutional Review Boards; Lung Inflammation; Pneumonitis; Pulmonary Inflammation; trial design; improved outcome; efficacy study; ventilation; COVID crisis; COVID epidemic; COVID pandemic; COVID-19 crisis; COVID-19 epidemic; COVID-19 global health crisis; COVID-19 global pandemic; COVID-19 health crisis; COVID-19 public health crisis; COVID19 crisis; COVID19 epidemic; COVID19 global health crisis; COVID19 global pandemic; COVID19 health crisis; COVID19 pandemic; COVID19 public health crisis; SARS-CoV-2 epidemic; SARS-CoV-2 global health crisis; SARS-CoV-2 global pandemic; SARS-CoV-2 pandemic; SARS-CoV2 epidemic; SARS-CoV2 pandemic; SARS-coronavirus-2 epidemic; SARS-coronavirus-2 pandemic; Severe Acute Respiratory Syndrome CoV 2 epidemic; Severe Acute Respiratory Syndrome CoV 2 pandemic; Severe acute respiratory syndrome coronavirus 2 epidemic; Severe acute respiratory syndrome coronavirus 2 pandemic; corona virus disease 2019 epidemic; corona virus disease 2019 pandemic; coronavirus disease 2019 crisis; coronavirus disease 2019 epidemic; coronavirus disease 2019 global health crisis; coronavirus disease 2019 global pandemic; coronavirus disease 2019 health crisis; coronavirus disease 2019 pandemic; coronavirus disease 2019 public health crisis; coronavirus disease crisis; coronavirus disease epidemic; coronavirus disease pandemic; coronavirus disease-19 global pandemic; coronavirus disease-19 pandemic; severe acute respiratory syndrome coronavirus 2 global health crisis; severe acute respiratory syndrome coronavirus 2 global pandemic; COVID-19 pandemic; pig model; piglet model; swine model; porcine model; manufacture; 21+ years old; Adult Human; adulthood; Adult; Air; air flow; airflow; Air Movements; Air Pressure; American Heart Association; Anesthesia; Anesthesia procedures; Animals; Breathing; Respiratory Aspiration; Respiratory Inspiration; inspiration; Award; Dysbarism; Barotrauma; Blood Pressure; Cadaver; cadaveric; cadavers; Calibration; Clinical Trials; Critical Illness; Critically Ill; Dangerousness; Disease; Disorder; Emergency Situation; Emergencies; Engineering; Feedback; Future; Gases; Patient Care; Patient Care Delivery; Grant; Hospitals; Human; Modern Man; Insufflation; Intubation; Lung; Lung Respiratory System; pulmonary; Lung Compliance; Manuals; Masks; mortality
