This is an engineering development and construction project which includes safety testing. In collaboration with American Emergency Vehicle Company, the largest ambulance manufacturing company in the United States, we are developing a prototype Hyperbaric Oxygen Chamber Equipped Stroke Treatment Ambulance. Once we complete the design, building, and safety testing of this prototype ambulance, the ambulance will become the foundation for a Phase II application to the National Institutes of Health to do human clinical trial testing necessary for FDA approval of the scientific principals outlined in our 2011 publication of successful hyperbaric oxygen human stroke treatment by McCormick, Houle, Saltzman, Whaley, and Roy. Our work is directed towards using ambulance based hyperbaric oxygen as a bridge to better acute stroke treatment with tPA for thousands more stroke patients each year.
In year 1 of the 2 year project, we will complete the manufacture of the custom built ambulance box, including all plumbing, and mounting necessary to run our two man mobile U.S. Navy pressure chamber in the ambulance box.
In year 2, we will complete the mating of the ambulance box to the ambulance chassis, and we will carry out pressure testing of the hyperbaric oxygen chamber in the ambulance—first in a static situation, and second in road tests. No human subjects will be used in this study. Chamber / Ambulance safety testing will be accomplished with engineering studies.
In year 3, 4 and 5, we plan to start clinical trials with acute stroke patients.
Clinical Trial Hyperbaric Oxygen Chamber Equipped Ambulance Procedure Treatment Plan
Stroke Ambulance comes to the patient’s home when they call 911 and is immediately used to reverse the patient’s stroke conditions in the hyperbaric oxygen chamber on the ambulance.
Hyperbaric Oxygen Chamber treatment of the patient is continued in the ambulance on the way to a hospital based stroke center.
Arriving at the hospital, patient is removed from the pressure chamber on the ambulance and taken into the emergency room for a CT scan.
The CT scan in the emergency room determines if the patient is having a clot based ischemic stroke (85% of cases) requiring transition to tPA thrombolytic therapy. If the CT scan determines the patient is having a hemorrhagic stroke (15% of cases) the patient is triaged to alternate medical and or surgical care.