Instrumentation for Monitoring Breath Biomarkers for Diagnosis of Health, Condition, Toxic Exposure, and Disease

Exhaled breath condensate (EBC) pH is a non-invasive measurement capable of identifying lung redox- and acid-stresses that occur in association with inflammatory conditions (pneumonia, trauma, asthma), acidic gas inhalation (chlorine), and gastric acid aspiration. Phase I efforts focused on the development of methodology to continuously measure EBC pH in critically ill or injured mechanically-ventilated patients in the ICU setting. This Phase I work resulted in a highly successful prototype that unequivocally proved the feasibility of this process, and additionally provided hundreds of thousands of EBC pH data points that reveal how this technology can predict respiratory deterioration and recovery in advance of other clinical indicators. Deviation of EBC pH in association with acid aspiration and endotracheal bicarbonate administration is easily identified with this technology. The phase II work plan involves optimization strategies that will result in final, manufacturing-ready prototypes, along with all production procedures necessary to have continuous EBC pH measurement technology ready to deploy the in military and civilian intensive care units, trauma centers, and operating rooms. In the near future, this technology will accompany oxygen saturation monitoring as standard practice in critically ill or injured patients requiring mechanical ventilation.