Respiratory Monitoring System That Detects & Predicts OIRD

Conditions

• Respiration Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Study to evaluate a Respiratory Monitoring System (RMS) with a Tracheal Sound Sensor (TSS) for detecting and predicting opioid induced respiratory Depression (OIRD). — DEVICE
  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.

Study Details

This study is being conducted to evaluate the ability of the Respiratory Monitoring System (RMS) to detect and predict opioid induced respiratory depression (OIRD) in post-operative surgical patients managed with opioid medications. The ability of the RMS to detect OIRD will be compared to the detection of OIRD using a commercial capnometer, pulse oximeter, airflow monitor, and breathing volume monitor . We hypothesize the RMS will detect the onset and progression of a true OIRD event with high sensitivity, specificity, positive predictive value, and negative predictive value. A true OIRD event will be determined by the reference device trend data. RTM Vital Signs, LLC is developing a Respiratory Monitoring System (RMS) that consists of a wearable Trachea Sound Sensor (TSS) and a software application that measures the sounds of air flow within the trachea during inhalation and exhalation and cardiovascular sounds. The sounds of airflow in the trachea are used to continuously monitor a patient's respiratory rate (RR), relative tidal volume (TV), relative minute ventilation (MV), pattern of breathing, duration of apnea in a healthcare setting. The cardiovascular sounds are used to continuously monitor pulse rate and PR variability. Once commercialized, clinicians will observe the RMS trend data on a smart phone, bedside display, or electronic medical record to determine whether the patient is breathing within their normal range, breathing more than their normal range (hyperventilation), breathing less than their normal range (hypoventilation), or not breathing (apnea). Real-time alerts and alarms will be based upon trends in a patient's rate and depth of breathing, number and duration of apnea events, RTM's Risk-Index-Score, and RTM's machine learning/artificial intelligence methods.

Key Dates

Start date

Jan 20, 2026

Status verified

Feb 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Other: Post-operative surgical patients routinely managed with opioid medications
  This is a non-significant risk clinical trial in 120 patients that are undergoing a surgical procedure that routinely utilizes parenteral and oral opioids for post-operative pain control. We plan to recruit and study a similar number of male/female patients with a range of ages and BMI.

Primary Outcome Measure

Evaluate RMS Trend Data Prior to Each True OIRD Event to Determine the Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value for Detecting and Predicting a True OIRD Event. [ Time Frame: From placement of the TSS and reference devices to device removal. A maximum of 24 hours of RMS and mask/pneumotach data in the PACU and a maximum of 24 hours of RMS and reference breathing data on the general wards, ICU, or intermediate ICU. ]

Locations (1)

Find similar trials in Philadelphia, PA

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