Respiratory Monitoring System That Detects & Predicts OIRD

Not yet recruitingOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

November 3, 2025

Primary Completion Date

October 3, 2026

Study Completion Date

November 30, 2026

Conditions
Respiration Disorders
Interventions
DEVICE

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.

Trial Locations (1)

19107

Thomas Jefferson University Hospital, Philadelphia

All Listed Sponsors
collaborator

RTM Vital Signs, LLC

INDUSTRY

collaborator

National Institute of Drug Abuse

FED

lead

Thomas Jefferson University

OTHER

NCT07217197 - Respiratory Monitoring System That Detects & Predicts OIRD | Biotech Hunter | Biotech Hunter