Personal Respiratory Isolation System for Safe Transport and Treatment of Patients with Highly Transmissible Infectious Diseases

PROJECT SUMMARY: The goal of this project is to develop a solution that allows for rapid, safe, and scalable initial treatment and transport of patients with highly transmissible infectious diseases, including COVID-19 as well influenza, tuberculosis, chickenpox, and measles. This is a necessary innovation because resource management and infectious transmission control were two of the greatest challenges healthcare providers faced when fighting the COVID-19 pandemic. When a patient is suffering from highly transmissible respiratory diseases and requires breathing assistance, they are placed in negative pressure rooms. However, given the limited supply of negative pressure rooms available to prevent virus transmission, and the misperception regarding the safety and effectiveness of negative pressure rooms, a new solution is needed. To help prevent the spread of highly transmissible infectious diseases, start-up company Inspire Rx has developed a personal negative pressure device called the AerosolVE™ BioHelmet. The BioHelmet is capable of preventing the spread of aerosolized pathogens while also enabling the use of non-invasive oxygen therapies on patients with respiratory diseases such as COVID-19, influenza, tuberculosis, etc. The negative pressure AerosolVE™ BioHelmet immediately isolates patients with any highly transmissible respiratory infectious disease and serves as an instant personal negative pressure environment that is more effective than a traditional negative pressure room. The BioHelmet is intended to provide safe transportation via ambulance, airplane, or helicopter, allowing critical transportation staff to remain safe, and it will be valuable in a variety of other healthcare settings. In this project the team will refine and further evaluate the AerosolVE BioHelmet, and they will leverage data from their previous in-cabin particle testing to advance the BioHelmet as an effective tool at keeping a vehicle/transport cabin free from potentially pathogenic respiratory particles. They will first refine the BioHelmet design to reduce noise and weight, and they will fabricate 100 AerosolVE BioHelmets and 20 pump units for follow-on bench testing and clinical user evaluations (Aim 1). They will conduct performance and bench testing at FDA-approved labs to ensure the safety and efficacy of the AerosolVE BioHelmet per FDA guidelines (Aim 2). They will deploy the helmet for clinical patient use during ground and air ambulance transportation of patients with suspected or confirmed communicable respiratory illness, including those requiring potential aerosol-generating procedures, and the purpose of this will be to obtain user feedback on comfort and east of use from patients and providers (Aim 3). The BioHelmet will provide a novel, compact, portable, and inexpensive solution that offers a safe negative pressure environment both inside and outside the hospital, which will ultimately save lives by allowing for needed patient treatments and protecting healthcare workers.