Devices Aim to Identify Those “At Risk” of OIRD

Medtronic hopes its new study will establish a role for pulse oximetry and capnography in patients on opioid medication.

Background

Patients with Opioid Induced Respiratory Depression (OIRD) experience a decrease in the effectiveness of ventilatory function, an ability to breathe, after opioid administration. Respiratory compromise is a potentially life-threatening, progressive condition negatively impacting a person’s ability to breathe. 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. This is where Medtronic clearly hopes it can step in. The company is using two of its diagnostic technologies to identify “at risk” individuals.

Medtronic’s 1,650-patient global study aims to identify individuals at high risk for OIRD. It is the first study to assess the clinical and economic benefits derived from the use of pulse oximetry and capnography, in patients receiving opioid medication on hospital general care floors. The first patient was enrolled in the study at The Ohio State University Wexner Medical Center.

The study is titled PRODIGY (PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY), and is a prospective, multi-center, post-market, global study conducted at 16 sites.

Through the development of a risk assessment scoring tool, the study will seek to identify patients at increased risk for respiratory compromise. It will evaluate hospital ward patients receiving opioids for post-surgical or non-surgical pain who are continuously monitored with capnography and oximetry. The study will also help inform clinicians’ understanding of the true incidence of respiratory compromise, which may be underestimated. The scoring tool will be used at the trial sites, with the goal of wider adoption across more hospitals following completion of the study.

The continuous monitoring of a patient’s oxygen and carbon dioxide levels will also allow PRODIGY to identify other causes of respiratory compromise in patients on the general care ward. Currently, ward patients’ breathing is monitored manually, and typically is no more frequent than every four hours.

Investigator comments

“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,” said Dr. Frank Overdyk, lead investigator of the PRODIGY study and a staff anesthesiologist at the Roper St. Francis Health System in Charleston, S.C.

Company comments

“The PRODIGY study is indicative of our commitment to bring attention to respiratory compromise – an under-recognized, serious health condition that’s preventable,” said Vafa Jamali, senior vice president and president of the Respiratory & Monitoring Solutions and Early Technologies businesses, which are part of the Minimally Invasive Therapies Group at Medtronic.

“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.”

Source: Medtronic, plc

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