Changes in 13CO2/12CO2 Delta Value in Exhaled Breath as an Early Indicator of Infection in Adult Trauma Subjects

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 doesn't 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.

In this single-center study of 110 subjects, breath samples will be collected 6 times per
day and blood samples will be collected once per day for 7 days. Subjects will be followed
for an additional 3 days. Analysis results of these samples will be combined with data that
is abstracted from the subjects' medical records. The investigators hypothesize that the
measurement of 13C/12C delta value in the exhaled breath of adults is an early indicator of
infection in subjects with systemic inflammatory response syndrome secondary to trauma.

Inclusion Criteria:

- Age 18 or older

- Admitted to Trauma Service (Surgical patient)

- Expected duration of hospital stay at least 120 hours (5 days) from time of
enrollment into study

- Calculated Injury severity score at time of enrollment greater than 15

- Enrolled within 48 hours of arrival to first treating institution (includes emergency
department at University of Wisconsin Hospitals and Clinics or outside hospital)

- Subject or surrogate speaks a language for which the institutional review board has
approved a consent form

Exclusion Criteria:

- Known infection at the time of enrollment, per Definitions section of the study
protocol

- Known antibiotic use in the 7 days prior to admission (note: antibiotic use within
the first 48 hours of hospital admission is acceptable)

- Known hemoglobin level less than 6.0 g/dL at any time between arrival to first
treating institution and enrollment

- Patient requires high-frequency ventilator strategy

- If not intubated: unable to cooperate with providing a breath sample

- Patients who are pregnant

- Prisoners

- Known participation in another interventional research study within 30 days prior to
enrollment (note: to be eligible, any interventional treatment must have ended at
least 30 days ago)