Researchers at the University of Michigan in Ann Arbor have developed a portable breath monitor capable of detecting acute respiratory distress syndrome, an often-deadly disease that causes fluid to leak into the lungs.
Today, diagnosis is based on a doctor’s judgement and time-consuming tests. The new technology, which is about the size of a shoebox, is designed to improve survival rates and lower the cost of care.
The device is a gas chromatography system and can diagnose the disease with nearly 90 percent accuracy in as little as 30 minutes. It can also serve as a real-time monitor for patients, helping to focus and adjust treatments in progress. Tests were completed by 48 patient volunteers at the U-M hospital, 21 of which had the condition.
“The most commonly used ARDS prediction tools are only correct about 18 percent of the time,” says Xudong (Sherman) Fan, a professor of biomedical engineering at U-M. “We’ve found that if our device tells us the patient is positive for ARDS, it’s highly likely that they’re positive. We are able to detect the onset and improvement of the condition before traditional changes in X-rays and blood testing would occur.”
The syndrome is a severe state of lung inflammation that can be caused by pneumonia, sepsis, trauma, aspiration, or a combination of these and carries a high mortality rate. In the U.S. each year, 200,000 cases are diagnosed, resulting in 72,000 deaths.
Many survivors are left with poor lung function and have difficulty returning to daily activities. There is no care for the condition, and mechanical ventilation in an intensive care unit is usually required to support the patient until the lung heals. Early detection improves outcomes.
The device samples a patient’s breath through tubing connected to the exhalation port of a mechanical ventilator. It analyzes nearly 100 volatile organic compounds, or biomarkers that can detect the syndrome and determine how far along the disease is. As treatment begins, the device can monitor its effectiveness.
Current tests include chest X-rays, which expose patients to radiation, and blood tests, which are invasive. The combination can take hours to analyze, and the results represent one snapshot in time. Tests must be repeated to know if the condition is changing.
“Our ability to improve outcomes with ARDS has been basically halted by the lack of technologies that can rapidly and accurately diagnose the disease early as well as track its progress,” says Kevin Ward, professor of emergency medicine and biomedical engineering at U-M. “All our current methods result in us treating the disease too late or not having information that tells us if our therapies are making a difference soon enough. By utilizing exhaled breath, the technology we have developed solves both problems and opens up significant opportunities to allow us to treat earlier and to develop a host of precision medicine therapies for ARDS.”
The researchers expect that the technology will also be useful in detecting and tracking other diseases including pneumonia, sepsis, asthma, and other diseases associated with lung or systemic blood inflammation.
The system is the result of a research and development partnership with the Michigan Center for Integrative Research in Critical Care. Its development was supported through U-M’s FFMI MTRAC program and National Institutes of Health R-21 and NCAI grants.
The university is pursuing patent protection for the intellectual property and is seeking commercialization partners to help bring the technology to market.
The research appears in the journal Analytical and Bioanalytical Chemistry and is titled “Rapid breath analysis for acute respiratory distress syndrome diagnostics using a portable two-dimensional gas chromatography device.”