AdvancedCPR Solutions LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Abstract Nearly of patients who suffer an out of hospital cardiac arrest CA die This leading cause of unexpected and sudden death in the US results in an enormous emotional psychological and financial burden to hundreds of thousands of families and communities across America annually Relative to the many potentially lethal disease states such as cancer stroke sepsis and trauma CA survival rates have barely improved since when manual standard S was first described Over the past years the applicants have discovered and developed new approaches techniques and devices to increase cerebral and coronary blood flow and improve neurologically sound survival after CA With prior NIH SBIR support they developed the impedance threshold device ITD performed animal and clinical trials and ultimately obtained FDA approval for manual active compression decompression ACD plus ITD the first device ever approved by the FDA to increase the likelihood of survival after CA Despite this progress further innovation is needed to substantively improve successful outcomes for more Americans This application is focused on a new discovery that elevation of the head and thorax during ACD ITD CPR results in a striking decrease in intracranial pressures and an increase in cerebral and coronary perfusion pressures These findings due to the effects of gravity when the head and heart are elevated have the potential to significantly further enhance cerebral and coronary blood flow and improve overall survivability The proposed research in an animal model of cardiac arrest is focused on demonstrating proof of concept that a new head up CPR device when used in combination with ACD ITD CPR is able to significantly improve blood flow to the heart and brain safely and effectively increase hour survival in an animal model of prolonged CA We further propose to assess the ergonomics and human factors associated with a light weight human prototypic head up CPR device in manikins and human cadavers with help of professional firefighters This novel and approach could increase neurologically favorable survival rates for andgt more Americans annually due to greater blood flow and lower intracranial pressure afforded by gravity enhanced head up CPR Narrative Sudden cardiac arrest is a leading cause of death in the USA with only neurologically intact survival for andgt out of hospital non traumatic cardiac arrest OHCA patients each year Closed chest standard S cardiopulmonary resuscitation CPR the current gold standard has remained largely unchanged since first described in S CPR is performed with the entire body in the horizontal plane While helping many patients S CPR is inherently inefficient generating only of normal vital organ perfusion S CPR can also result in simultaneously high arterial and venous percussion waves to the brain with each compression creating the potential for harmful increases in intracranial pressure ICP with every compression New CPR devices and methods like active compression decompression ACD and the impedance threshold device ITD developed by the PI and others over the past years enhance cardio cerebral perfusion and survival with favorable brain function by a relative versus S CPR The ACD ITD combination is only CPR device to date approved by the FDA to increase the likelihood of survival after OHCA The PI received multiple NIH SBIR awards for the pre clinical and clinical work on ACD ITD In Zoll Medical bought this technology and recently has started to market it Despite this progress further innovation is needed as most OHCA patients still die The centerpiece of this new Phase application is a novel Head Up Position HUP device designed to improve neurologically favorable survival after cardiac arrest HUP CPR increases cardio cerebral circulation and reduces the potential for brain injury with each chest compression This Phase application is focused on establishing preclinical proof of concept for the HUP CPR device and building the first human prototype for clinical evaluation The applicants have previously demonstrated that positive and negative changes in intrathoracic pressure during CPR are immediately transmitted to the brain Changes in intrathoracic pressure can impact cerebral perfusion during cardiac arrest brain injury and shock ACD ITD CPR was developed in part to harness this physiology and improve cardio cerebral circulation Building upon ACD ITD the applicants discovered the concepts underlying HUP CPR in when comparing CPR with whole body head up tilt versus whole body head down tilt HUP CPR involves elevating the heart and the head about and cm respectively We have assessed this new idea in animals in cardiac arrest and human cadavers This modest elevation immediately enhances venous drainage from the brain and lowers ICP lowers right atrial pressures increases cardiac preload and redistributes blood flow within the lungs thereby improving respiration and circulation within the lungs These mechanisms contribute to a clinically significant increase in cardio cerebral circulation and reduce the potential brain trauma associated with excessively high levels of ICP with each chest compression Further studies in a human cadaver model demonstrated that HUP CPR immediately reduces ICP and enhances cerebral perfusion pressure Additional animal studies have also demonstrated that HUP CPR does not work with conventional S CPR S CPR does not provide enough forward flow to pump blood uphill with head elevation In contrast ACD ITD CPR provides nearly three times more blood flow to the heart and brain compared with S CPR thus making it feasible and practical to perform HUP CPR Based upon this potential advance the applicants propose to perform a series of proof of concept studies to determine if HUP CPR provides superior cerebral blood flow hemodynamics and hour neurologically intact survival rates compared with CPR in the supine position in a pig model of prolonged cardiac arrest We further propose to build a light weight HUP CPR device prototype and assess its ease of use during manual ACD ITD CPR and LUCAS ITD CPR A successful preclinical safety and effectiveness study will be the basis for the first human evaluation of head up CPR HUP CPR has the potential to be a major breakthrough in the treatment of cardiac arrest worldwide especially when integrated into an overall systems based approach to pre and post resuscitation care