120
Participants
Start Date
November 3, 2025
Primary Completion Date
October 3, 2026
Study Completion Date
November 30, 2026
Observational study to evaluate a Respiratory Monitoring System (RMS) with a Tracheal Sound Sensor (TSS) for detecting and predicting opioid induced respiratory Depression (OIRD).
Expert clinicians will evaluate the ability of the RMS sensor and diagnostic algorithms to detect and predict true OIRD events in post-operative patients routinely managed with opioid medications. Expert clinicians will adjudicate detailed reference data and EMR data to identify a true OIRD event. The definition of a true OIRD event will be based upon the PRODIGY Study definition and RTM definition of a true event. Performance of the RMS will be based upon the sensitivity, specificity, positive predictive value, and negative predictive value for detecting true OIRD events.
Thomas Jefferson University Hospital, Philadelphia
RTM Vital Signs, LLC
INDUSTRY
National Institute of Drug Abuse
FED
Thomas Jefferson University
OTHER