Medtronic plc has announced preliminary results from PRODIGY, a Medtronic-sponsored, prospective, multi-center study to identify people at high risk for opioid-induced respiratory depression (OIRD), a form of respiratory compromise.
Background
Respiratory compromise is a potentially life-threatening, progressive condition. Sufferers lose the ability to breathe adequately to maintain oxygenation and carbon dioxide removal. Patients with OIRD may experience shallow, slow or no breathing after opioid administration which undetected can lead to cardiopulmonary arrest and death. This condition is rapidly becoming the third-most costly hospital inpatient expense in the U.S., and dramatically increases the likelihood of adverse patient outcomes and cost of patient care. Not only is respiratory compromise common and dangerous, it has been very difficult to predict.
The newly announced study results have demonstrated that investigators were able to develop an easy-to-use risk prediction tool to identify patients at high risk of developing respiratory compromise. In addition, results showed that more than 40 percent of patients on the general care floor experienced OIRD, which is significantly higher than previously reported in clinical literature.
The PRODIGY (PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY) study included 1,496 patients across 16 sites in the U.S., Europe and Asia. This is the largest known study using continuous capnography and oximetry. The initial study publication, “Seeking Answers from the PRODIGY Trial,” in the Journal of Critical Care, reviewed respiratory compromise on the general care floor and the study methodology. Continuous capnography and pulse oximetry data were collected using Medtronic Microstream™ and Nellcor™ monitoring technology. Data presented by Dr. Ashish K. Khanna an associate professor of anesthesiology and intensivist at the Wake Forest School of Medicine, showed OIRD occurred in 46 percent of patients. Additionally, all patients experiencing these events were reviewed and confirmed by an independent clinical event committee of physicians with expertise in perioperative respiratory medicine.
Clinician comments
“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,” said Dr Khanna, M.D., primary study investigator. He added; “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.”
Company comments
“The PRODIGY study reflects our commitment to improving solutions for respiratory compromise – a common, costly and deadly but preventable condition,” said Vafa Jamali, senior vice president and president of the Respiratory, Gastrointestinal & Informatics business, which is part of the Minimally Invasive Therapies Group at Medtronic. “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.”
Source: Medtronic plc
