SBIR-STTR Award

The exhaled breath condensate (EBC) sampling procedure is as simple and safe as blowing through a straw, yet provides substrate (EBC) for assays that have proven remarkably useful in identifying lung inflammation and oxidative stress. Most validated is the measurement of EBC pH, which is profoundly low (acidic) in many lung diseases and reflects underlying airway acidification. This proposal seeks funding for development of a continuous exhaled breath pH monitoring system and tests its utility by applying EBC pH measurement to the Intensive Care Unit environment. This novel system to measure minute-by-minute EBC pH will be employed to determine if EBC acidification will predict development of, or worsening of, severe lung diseases including ventilator-associated pneumonia and acute respiratory distress syndrome with or without trauma. Identifying such progression early may allow more successful therapeutic intervention. Additionally examined will be the ability of single EBC pH assays to predict the need for hospitalization in patients presenting to the emergency room with respiratory complaints. These readily available clinical model systems will help determine the utility of EBC pH to provide useful information regarding war-fighters' health

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.

Keywords:
Exhaled Breath Condensate Ph, Lung Injury, Pneumonia, Lung Trauma, Continuous Non-Invasive Lung Moni