A Dual-Setting Airway Device for Optimized Hemodynamics in Cardiac Arrest and Post-Resuscitation States

About This Grant

Abstract Sudden cardiac arrest (SCA) remains the leading cause of death among American adults, claiming more than 350,000 lives annually outside of hospitals and a comparable number within hospitals. Despite widespread deployment of conventional closed-chest cardiopulmonary resuscitation (C-CPR) and defibrillation, out-of- hospital survival with good neurological outcome has remained below 10% for over six decades. In 2014, our team discovered Head-Up CPR (HUP-CPR), a novel resuscitation approach that leverages gravity to lower intracranial pressure, improve venous return, and enhance cerebral perfusion. Clinical adoption of HUP-CPR has demonstrated markedly improved survival when implemented early by first responders, but the full physiological benefit depends critically on the use of an impedance threshold device (ITD). The current FDA- cleared ITD (ResQPOD®) employs a fixed cracking pressure, limiting its adaptability across diverse patient states. Optimal resistance differs substantially between conditions: higher cracking pressures (-10 to -16 cmH₂O) augment circulation during CPR, whereas lower settings (-6 cmH₂O) reduce the work of breathing while still supporting hemodynamics in spontaneously breathing patients recovering post-resuscitation or experiencing hypotension from trauma, hemorrhage, or sepsis. To address this gap, we have designed the Adjustable Pressure for Emergency Care (APEC) device, the first ITD with dual selectable cracking pressures (-6 and -12 cmH₂O) for rapid, on-the-fly adjustment in the field. The goals of this Phase I SBIR are: 1) refine the APEC design and conduct bench testing to confirm performance specifications, pressure–flow characteristics, dead space volume, and durability; and 2) evaluate hemodynamic and respiratory performance in a porcine model of cardiac arrest and post-ROSC spontaneous breathing. Key innovations include a pluripotential inspiratory resistance system with instant mechanical switch between pressure settings, integrated viral/bacterial filtration, reduced internal dead space for safer use in infants and children, as well as adults, with minimal mixing of inspired and expired gases, and a right-angled resuscitator bag port to reduce airway dislodgement. By enabling clinicians and first responders to tailor intrathoracic pressure to the patient’s physiological state, the APEC has the potential to broaden the clinical utility of ITD technology beyond CPR alone, improve hemodynamic performance across multiple hypotensive conditions, reduce the chances for pulmonary edema, and accelerate translation to clinical practice through the FDA 510(k) pathway. Successful development of the APEC device would represent a major step forward in addressing the decades-long stagnation in cardiac arrest survival and improving outcomes for patients with life-threatening hypotension.