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Infections detected earlier in pediatric clinical tests of Isomark’s non-invasive ‘Canary’ breath analyzer

MADISON – A study of 17 mechanically ventilated pediatric patients, ranging in age from one month to nearly 18 years old, has demonstrated a link between breath carbon isotope “delta values” and inflammatory acute phase response. The results differentiated between healthy and infected patients.

The study, conducted at the University of Wisconsin Hospitals and Clinics, examined the relationship between breath delta values and early diagnosis of Systemic Inflammatory Response Syndrome. The onset of SIRS, which occurs in 82 percent of patients admitted to pediatric intensive care units, can lead to sepsis.

Sepsis, severe sepsis and septic shock are types of systemic infections caused by a micro-organism, such as bacteria or viruses, and may lead to organ dysfunction and death. Sepsis ranks as the most common cause of death of infants and children in the world.

The study was an observational pilot conducted in the pediatric ICU at the American Family Children’s Hospital, a part of the larger UW Hospitals and Clinics. The 17 patients underwent measurement of exhaled breath delta values, or BDVs, every eight hours for 72 hours. Nine of the 17 met SIRS criteria at the time of enrollment, four of which had undergone shock due to their infections.

Whether in the SIRS or non-SIRS group, the BDVs correlated with the severity of systemic inflammation when based on the patients’ inflammatory acute phrase response. That can serve as an early-warning signal to clinicians.

The breath delta value can be thought of as “the temperature of the immune system,” and provides a biomarker for infections at the earliest moments.

“Early detection of bacterial sepsis followed by immediate intervention is critical for successful outcomes to patient care,” read a study published in February in the Royal Academy of Chemistry. “Current clinical methods are often unreliable in detecting early bacterial sepsis; accordingly, there is great interest in identifying laboratory methods for early detection of sepsis.”

In the United States alone, there were more than 47,000 cases of severe sepsis in children aged 19 or younger in 1999. Hospital mortality rate for those children was estimated at 9 percent for that year. The estimated annual total costs were $2.3 billion for pediatric patients in the United States alone for that year.

Overall, hospital-acquired infections cost the U.S. healthcare between $35 billion and $88 billion per year. In 2008, Medicare stopped reimbursing for the additional costs related to treating hospital-acquired infections in adults.

Trial design:

The Institutional Review Board at the UW-Madison approved the study; the principal investigator was Dr. Juan Boriosi. All patients in the PICU were prospectively screened for participation; informed consent was obtained for all participants. Mechanically ventilated patients (orotracheal, nasotracheral and tracheotomy) only were enrolled. Enrollees were classified into SIRS, No-SIRS and “SIRS with shock” groups. Isomark LLC analyzed all carbon samples. The expired air was placed in a gas-tight bag with a de-identified sample number by a respiratory therapist at the point of care. The bag was verified to maintain the carbon stable isotope ratio for greater than 72 hours. To ensure accurate measurements, all breath samples were analyzed within 48 hours of collections, and typically within 24 hours.

About the company:

Isomark’s Canary Breath Delta Value analyzer uses patented, breath-monitoring technology to detect infections up to 48 hours before standard methods. Isomark’s technology is exclusively licensed from the Wisconsin Alumni Research Foundation, with the most recent patent being issued in August 2013. The initial target market for Isomark is the intensive care unit, where hospital-acquired infections such as sepsis and ventilator-associated pneumonia are common, serious problems. Isomark has previously been awarded a $500,000 Small Business Innovation Research grant by the National Institutes of Health. The identified regulatory pathway for the U.S. Food and Drug Administration is a de novo, 510k, multiple-center trial with up to 600 patients.

Learn more about the study:


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