Respiratory Monitoring System That Detects & Predicts OIRD

NCT07217197 | Enrolling By Invitation FDA Device

• 2 other identifiers: R44DA0594914R44DA059491-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiration Disorders

Keywords

respiratory depression; respiratory monitoring system; tidal volume; minute ventilation; respiratory rate; tracheal sound sensor; opioid induced respiratory depression; breathing

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluate the recorded RMS trend data using a variety of analytical methods (pattern recognition, Risk-Index-Score, machine learning/artificial intelligence) to determine the sensitivity, specificity, positive predictive value, and negative predictive value for detecting a true OIRD event in post-operative surgical patients being managed with opioid medications for pain control.

  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.

Secondary Outcomes (2)

• Correlate RMS breathing data to reference breathing data to determine accuracy and precision of measurement.

  Baseline -RMS, Hamilton and ExSpiron reference data (15 min max). PACU- RMS, Hamilton , ExSpiron, and Capnostream reference data (90 min max for mask/pnuemotach). Hospital Wards, ICU, iICU- RMS, ExSpiron and Capnostream (reference data 24 hours max).

• RMS Safety Endpoint

  From TSS adhesion on the neck to removal of the TSS for 26+ hours of wear-time.

Study Arms (1)

Post-operative surgical patients routinely managed with opioid medications

OTHER

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.

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

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.

Post-operative surgical patients routinely managed with opioid medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical patients routinely managed post-op with opioid medication as their primary analgesic for break through pain.
• Age ≥ 18 years
• BMI 20 to 40
• American Society of Anesthesiologists physical status I, II, and III.
• Understands written and spoken English language

You may not qualify if:

• Age \< 18 years.
• BMI \< 20 or \> 40.
• American Society of Anesthesiologists physical status IV and V.
• Active Do Not Resuscitate (DNR) order.
• Does not understand written and spoken English well.
• Anxiety or claustrophobia related to wearing a face mask or nasal cannula.
• History of skin irritation or inflammation related to the adhesives or materials used in the TSS sensor, facemask, nasal cannula, or pulse oximeter probe.
• Active infection or inflammation of the skin above the proximal trachea.
• Anticipated hospital length of stay less than 24 hours.
• Excessive facial hair that may prevent attachment of the RMS sensor
• Unstable cardiovascular or pulmonary function or any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff (e.g., known history of hepatitis B or C).
• Pregnancy or breast feeding.
• Current participation in an industry sponsored pharmaceutical study or a medical device study.

Sponsors & Collaborators

• RTM Vital Signs, LLC: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

• Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

  PMID: 32925318 BACKGROUND

• Mildh LH, Scheinin H, Kirvela OA. The concentration-effect relationship of the respiratory depressant effects of alfentanil and fentanyl. Anesth Analg. 2001 Oct;93(4):939-46. doi: 10.1097/00000539-200110000-00028.

  PMID: 11574361 BACKGROUND

• Yadollahi A, Moussavi ZM. Acoustical respiratory flow. A review of reliable methods for measuring air flow. IEEE Eng Med Biol Mag. 2007 Jan-Feb;26(1):56-61. doi: 10.1109/memb.2007.289122. No abstract available.

  PMID: 17278773 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders; Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc C Torjman, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Jeffrey I Joseph, DO

  Thomas Jefferson University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)