Medtronic has said that preliminary results from a prospective, multi-center study to identify patients at high risk for opioid-induced respiratory compromise offered easy-to-use risk prediction tool.
The study, dubbed PRODIGY, is a Medtronic-sponsored, prospective, multi-center study to identify people at high risk for opioid-induced respiratory depression (OIRD), a form of respiratory compromise.
The medical technology company said that the study results demonstrated the investigators to develop an easy-to-use risk prediction tool that identifies patients at high risk of developing respiratory compromise, a potentially life-threatening condition causing a progressive inability to breathe adequately.
Furthermore, results 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 study was intended to develop and internally validate an accurate risk assessment scoring tool – the PRODIGY score, which identifies adults on the hospital general care floor receiving opioid medication and are at increased risk for OIRD.
Medtronic said that the risk assessment score has been developed based on variables that included age, gender, sleep disorders, chronic heart failure and opioid naivety.
The company claims that the PRODIGY performed well and the score has identified 76% of patients with confirmed respiratory depression (AUC=0.7620) and the full results are expected to be published in 2019.
Associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine and primary study investigator Ashish Khanna said: “Clinical evidence shows that acute and unexpected respiratory compromise on the general care floor is increasingly common. Until now, we have not been successful in predicting which patients are at high risk when recovering on the general care floor.
“These data validate an easy-to-use OIRD risk prediction tool to identify patients at the highest risk and guide early intervention using continuous capnography-based monitoring. Early identification and intervention in these high-risk patients has the potential to improve patient safety and decrease the economic and clinical burden of unplanned ICU admissions.”
The PRODIGY study included 1,496 patients across 16 US sites, Europe and Asia. This is the largest known study using continuous capnography and oximetry.
Medtronic senior vice president and president of the Respiratory, Gastrointestinal & Informatics business Vafa Jamali said: “The PRODIGY study reflects our commitment to improving solutions for respiratory compromise – a common, costly and deadly but preventable condition.
“We are encouraged by the data demonstrating the use of the PRODIGY OIRD risk prediction tool. It can help clinicians prioritize resources by identifying those patients at highest risk on the general care floor who should be continuously monitored with capnography and pulse oximetry.”