Biomedical engineering is bringing gas chromatography technology bedside, potentially making detection of certain conditions dramatically easier.
Hand-held breathalyzers have been used for decades to measure the alcohol in a person's bloodstream. But what if they were able to detect illness?
Researchers at the University of Michigan have developed a point-of-care device that can do just that: diagnose life-threatening lung diseases using only a patient's breath.
Exhaled breath contains hundreds of volatile organic compounds that carry important information about our physiology. Diseases can impact volatile organic compound combinations and create unique patterns known as breathomic signatures.
Kevin Ward, M.D., executive director of the Michigan Center for Integrative Research in Critical Care and professor of emergency medicine and biomedical engineering, partnered with Xudong Fan, Ph.D., associate director of MCIRCC and professor of biomedical engineering, to develop a device that recognizes and analyzes breathomic signatures to help guide diagnosis.
While the technology, known as gas chromatography, has existed for years, the machines have never been practical for bedside monitoring. Ward and Fan have re-engineered this technology to analyze vapor molecules in parts per billion.
"We're able to get high-fidelity results in a much smaller package, and there's no additional cost to the patient," Fan says.
The researchers think the device could help detect diseases such as acute respiratory distress syndrome (ARDS) days before physicians could make the diagnosis on their own.
ARDS causes a buildup of fluid in the alveoli of the lungs, making it difficult for oxygen to reach other organs. The American Lung Association estimates 200,000 patients are diagnosed with ARDS each year. The disease is notoriously difficult to detect, which is why it has such a high morbidity rate — 30 to 50 percent of patients die from the disease.
"ARDS is one of those diseases with a man-made definition," Ward says. "You can't run a simple blood test or biopsy the lung, so it's often tough to catch before it's too late. Even conventional chest X-rays change late and can be difficult to interpret."
And unlike biopsies or blood, breath can be collected easily and continuously, making it an ideal sample.
We're able to get high-fidelity results in a much smaller package, and there's no additional cost to the patient.Xudong Fan, Ph.D.
Ward and Fan's micro-gas chromatography device is fully automated and weighs only 9 pounds. The device uses an algorithm that can generate diagnostic results in less than 20 minutes, so monitoring takes place in real time. It is also useful for monitoring patient trajectory once treatment has begun.
"Once you're able to confirm the ARDS diagnosis and begin treating the patient, it can take a while to know if your treatment changes are working," Ward says. "This device enables a breath-by-breath way to track progress, and you can know very early whether you're going in the right direction."
Additional team members include Robert Dickson, M.D., assistant professor of internal medicine and associate director of MCIRCC. Dickson is an expert in critical care and the role of the microbiome in ARDS and sepsis.
Although treating ARDS is their main focus, Ward and Fan envision this device improving outcomes for other inflammatory diseases such as pneumonia, sepsis and asthma.
The team, initially funded by Fast Forward Medical Innovation's Michigan Translational Research and Commercialization program, has also received funding from the National Institutes of Health's Centers for Accelerated Innovations based at the Cleveland Clinic.
The data to date have been so promising that the team recently received a National Institutes of Health R21 exploratory/developmental grant to advance the technology and test it in more patients. The team has several pending patents and is exploring starting a company around the technology.
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