Fully Automated Basic Life Services Resuscitation System to Improve Survival after Cardiac Arrest

Abstract The overall goal of this application is to improve neurologically-intact survival rates after sudden cardiac arrest (SCA). Still a leading cause of death, <10% of the more than 600,000 SCA patients in the US each year survive with favorable neurological function.

We propose to develop and evaluate a novel comprehensive Head Up (HUP) cardiopulmonary resuscitation (CPR) System designed primarily to allow Basic Life Services (BLS) providers (a fire crew without paramedics) to rapidly deliver fully automated CPR, including for the first time, automated synchronized mechanical positive pressure ventilation (PPV), to increase the likelihood of neurologically intact survival after SCA and increase crew safety.

The proposal focuses on further developing and delivering an innovative all-in-one device for BLS teams based on our most recent breakthroughs in optimizing brain perfusion during SCA using controlled sequential elevation of the head and thorax in combination with the use of Active Compression Decompression (ACD) CPR and an impedance threshold device (ITD).

As demonstrated in a well-accepted porcine SCA model, HUP CPR combined with ACD CPR and an ITD uniquely harnesses gravity to enhance drainage of venous blood from the head and neck, lower intracranial pressure, and markedly increase systemic and cerebral blood flow and likelihood for survival.

The overall objectives of this application are also supported by new clinical data from a CPR Registry of patients receiving HUP CPR suggesting this comprehensive approach may provide the most benefit when deployed rapidly.

Moreover, in resource-strapped Emergency Medical Services (EMS) systems across the country there is a growing need to develop technology that minimizes the number of resources required to deliver high quality CPR that is best for patient outcomes and safer for rescue personnel.

We propose to achieve these collective objectives by demonstrating that incorporation of automated positive pressure ventilation (PPV), synchronized to the decompression phase of an easy to deploy and fully automated HUP CPR system, is feasible and safe for BLS providers, will reduce CPR personnel resource requirements, and most importantly, will optimize chances for neurologically intact survival after SCA.

This combination of innovations, described herein as the SAVE CPR System, represents the combination of Synchronization, ACD+ITD, Ventilation, and Elevation.

As such, the Specific Aims are: 1) Design and prototype an improved Head Up CPR device which includes automated PPV that is synchronized with the decompression phase of ACD CPR; 2) Determine if the SAVE CPR System will increase 24-hour survival with favorable brain function when implemented immediately after 10 minutes of untreated cardiac arrest compared with a delayed implementation strategy whereby SAVE is initiated after 10 minutes of untreated cardiac arrest and 8 minutes of conventional CPR to simulate Advanced Life Support (ALS) rather than BLS deployment of the SAVE CPR System; and 3) Test the feasibility of use of the SAVE CPR System by BLS providers in simulated cardiac arrest scenarios using manikins and human cadavers to determine if rescuers can rapidly deploy and utilize the SAVE System and to evaluate what potential improvements are necessary for a commercially viable version.

We anticipate being able to demonstrate a) the ability to incorporate a PPV delivery device into the SAVE CPR System b) pre-clinical proof-of-concept that the SAVE CPR System will significantly improve neurologically-sound survival in pigs when deployed rapidly versus deploying the SAVE CPR System after a period of traditional conventional CPR, and c) that the SAVE CPR can be easily and rapidly applied by BLS providers.