How a Medtronic-Sponsored Study Could Help Hospitals Save Lives and Money

Medtronic announced preliminary results from PRODIGY, a prospective, multi-center study to identify people at high risk for opioid-induced respiratory depression, a form of respiratory compromise.

Through the PRODIGY study, investigators developed a risk prediction tool to identify patients at the highest risk of developing opioid-induced respiratory depression. The tool will hopefully guide early intervention using continuous capnography-based monitoring such as Medtronic's Capnostream device, shown above.

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The results of a Medtronic-sponsored study could go a long way toward helping hospitals identify patients at high risk of developing opioid-induced respiratory depression (OIRD), a form of respiratory compromise.

Last year MD+DI spoke with Ashish Khanna, MD, primary study investigator for the PRODIGY study, about how challenging it is to predict episodes or severity of cardiorespiratory decompression in patients who appear to be in stable condition and staying on the general care floor. Khanna, who is now an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine, said that the PRODIGY data would help uncover patterns to determine real-time predictors of which patients are likely to experience respiratory depression when they might experience it, and which patients should receive more intensive monitoring than the current standard of care.

“My hope is that someday you’re going to walk into a hospital and you’re going to get a smart device, almost like an iWatch, on you that will continuously monitor you through your surgery, through your stay in the hospital, and possibly even after you go home because these events happen at home as well,” Khanna said. "The PRODIGY trial is going to push a step closer to better monitoring and allow for quicker recovery for our patients."

Through the PRODIGY study, investigators were able to develop a risk prediction tool to identify patients at high risk of developing respiratory compromise. The results also showed that more than 40% of patients on the general care floor experienced OIRD, which is significantly higher than previously reported in clinical literature.

The risk assessment scoring tool, dubbed the PRODIGY score, identifies adults on the hospital general care floor receiving opioid medication who are at increased risk for OIRD. Variables used to develop the risk assessment score included age, gender, sleep disorders, chronic heart failure, and opioid naïvety.

The PRODIGY score identified 76% of patients with confirmed respiratory depression. Medtronic said the full results are expected to be published in 2019. The study, presented at the Society of Critical Care Medicine's 48th Critical Care Congress in San Diego, CA, was selected for the Star Research Achievement Award recognizing excellence in research.

Khanna said the OIRD risk prediction tool to identify patients at the highest risk will hopefully guide early intervention using continuous capnography-based monitoring such as Medtronic's Capnostream device, which the company inherited through its Covidien acquisition. Early intervention has the potential to improve patient safety and decrease the economic and clinical burden of unplanned admissions to the intensive care unit, he said.

The PRODIGY (PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY) study included 1,496 patients across 16 sites in the United States, Europe, and Asia. This is the largest known study using continuous capnography and oximetry.

What Does the Capnostream Monitor Do?

Medtronic's Capnostream respiratory monitor is designed to enable continuous monitoring of end-tidal carbon dioxide (etCO2), respiratory rate (RR), heart rate, and pulse oximetry (SpO2) in patients in nearly any clinical setting. The device combines the company's Microstream capnography technology and Nellcor pulse oximetry technology in a portable monitor, designed with features intended to enhance efficient workflow. The monitor also includes the Integrated Pulmonary Index (IPI) algorithm, which was developed to help simplify monitoring a patient's complete respiratory status. The IPI incorporates the etCO2, RR, SpO2, and pulse rate into a single number, which is displayed on a scale from 1 to 10, with 10 indicating a normal respiratory status. 

"I think that the clinical benefits are clear. The issue that sometimes you have with proactive monitoring is compliance," said Vafa Jamali senior vice president and president of the respiratory, gastrointestinal and informatics business, which is part of the minimally invasive therapies group at Medtronic. "If you try to monitor every single patient you have a very large workflow burden for the caregiver. So if we can find the best patient cohort and narrow it down to a high-risk group, then we can advocate for compliance and therefore get a far better clinical adoption in the care setting."

Jamali told MD+DI that the goal is to keep going deeper and deeper with the data in order to determine what is the most cost-effective group to be monitored with capnography.

"The score allows the customer to really understand which group is at risk, and then the study, the clinical evidence, is going to show that the risk is actually quite high for that group. So by not complying to standards that are available right now, they're putting a large number of patients at risk," he said.

That, combined with the potential cost-effectiveness of proactive monitoring for high-risk patients, is what will help make the case for investing in the technology.

There's no healthcare system in the world that isn't looking at cost-effectiveness, Jamali said, so those two things have to go hand-in-hand and I think the study can show where the cost-effectiveness and the benfits overlap."

Medtronic has been leading the charge toward value-based care in the industry by building an evidence-based guarantee around certain products and CEO Omar Ishrak has talked during recent earnings calls about how the company's value-based care programs are paying off.

"This is the perfect type of product for a value-based care agreement where you're guaranteeing outcomes based on evidence and now we have robust evidence that we can [help us] improve our claim," Jamali said. "We are doing a number of value-based care agreements. We've got a very large one underway on the East Coast of the United States and we will continue to tweak it, and every time we get new evidence we can improve that pledge that we make to customers. I see this as a really important part of our value-based program globally for Medtronic."

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