Medtronic (NYSE:MDT) said today that it’s starting a large study on the effect of pulse oximetry and capnography in opioid-induced respiratory depression, using its Capnostream device.
The 1,650-patient Prodigy study aims to create a tool to score the risk of OIRD in patients being treated with opioids for pain, using Capnostream’s continuous pulse oximetry and capnography monitoring over 48 hours. The study is slated for a final data collection for the primary outcome in February 2018 and an estimated completion date a month later, according to ClinicalTrials.gov.
“The Prodigy study allows us to deepen our understanding of the development of respiratory compromise, including OIRD, and determine strategies for earlier detection and prevention,” co-lead investigator Dr. Frank Overdyk, of the Roper St. Francis Health System in Charleston, S.C., said in prepared remarks.
The other lead investigators are Dr. Wolfgang Buhre of Holland’s Maastricht University Medical Centre and Dr. Ashish Khanna of Cleveland Clinic’s Lerner College of Medicine of the Case Western Reserve University, Medtronic said.
“The Prodigy study is indicative of our commitment to bring attention to respiratory compromise – an under-recognized, serious health condition that’s preventable,” added SVP Vafa Jamali. “Information is powerful and the ability to identify patients at risk for respiratory compromise who could benefit from continuous capnography and oximetry monitoring may improve patient safety throughout the hospital.”
Medtronic acquired Capnostream in the $50 billion buyout of Covidien, which itself acquired the technology with its $300 million acquisition of Israel’s Oridion in June 2012.
