Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients

Sepsis is a major complication for any patient, and its management is an acknowledged challenge for intensivists. Sepsis has unpredictable onset and progression, and is a leading cause of death in ICUs with a mortality rate of 30-50%. Annually in the US, 1.4M cases involve hospitalization, 750,000 cases of severe sepsis or septic shock, and \~260,000 cases of sepsis related death have been reported in recent years. Current experience of UF Health investigators in surgical ICUs is 1 -2 sepsis, severe sepsis, or septic shock patients per day, of which \~10% are trauma patients. Of trauma patients, \~8% develop sepsis during their ICU stay. Breath delta value is hypothesized to be a biomarker of infection. Breath delta value is not a defined clinical outcome related to human health, because this study is seeking to establish breath delta value as a biomarker of infection. This study is measuring the feasibility of the Isomark Canary™ device. If the Canary does not detect a significant decrease in breath delta value in those subjects who subsequently get an infection, it will not be feasible to use it for this purpose. Breath delta value will be collected to determine its relationship to infection, no health outcomes are being measured. This study is designed to determine if the BDV of adult ICU patients is an early indicator of the onset of infection that may lead to sepsis. The objectives of this study are: (1) to measure variation of BDV with time in adult ICU patients who agree to participate as research subjects; (2) to determine the magnitude of change of BDV in subjects who are subsequently diagnosed with severe infection and sepsis; (3) to define variation of BDV in adult trauma subjects who do not develop severe infection.