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.

Inclusion Criteria:

1. age 18 years or older

2. critically ill patient admitted to trauma or surgical ICU

3. expected duration of hospital stay at least 120 hours (five days) from time of study
enrollment

4. subject/LAR speaks a language of which the IRB has approved a consent form

Exclusion Criteria:

1. known infection at the time of enrollment per infection definitions in section 6.2

2. known use of systemic antibiotic, antimicrobial and/or antifungal therapy within the
last 7 days (See Antibiotic Use section below)

3. prolonged antibiotic or antimicrobial use during the perioperative period (See
Antibiotic Use section below)

4. currently active cancer, or receiving treatment for cancer (including but not limited
to: radiation, chemotherapy, systemic orals, etc)

5. receiving high frequency ventilatory support

6. if not intubated, unable to cooperate with providing a breath sample

7. expected death within 24 hours of enrollment or lack of commitment to aggressive
treatment by family/medical team (e.g., likely to withdraw life support measures
within 24 hrs of screening)

8. female who is pregnant or lactating (negative serum or urine pregnancy test results
within 48 hours of enrollment or to be performed during screening)

9. prisoner

10. known participation in an interventional research study within 30 days prior to
enrollment (note: to be eligible, any interventional treatment must have ended at
least 30 days ago)

11. Individuals who are directly affiliated with sponsor or study staff, or their
immediate families. Immediate family is defined as spouse, domestic partner, parent,
child, or sibling whether legally adopted or biological.

12. Any patient that is deemed unfit for study participation, per the Investigator's
discretion.