Thomas Jefferson University
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.
TJU research personnel will be trained by RTM personnel to ensure all questions related to the proper use of the device and study methods are addressed prior to application and use. Subject Screening: Patients scheduled for surgery at Thomas Jefferson University Hospital will be screened for recruitment and enrollment. Potential study subjects will be contacted by a research coordinator for pre-screening, screening for inclusion/exclusion criteria, and initial informed consent. The following assessments will be performed as part of the screening and eligibility evaluation: 1. Type of surger…
Inclusion Criteria: 1. Surgical patients routinely managed post-op with opioid medication as their primary analgesic for break through pain. 2. Age ≥ 18 years 3. BMI 20 to 40 4. American Society of Anesthesiologists physical status I, II, and III. 5. Understands written and spoken English language Exclusion Criteria: 1. Age \< 18 years. 2. BMI \< 20 or \> 40. 3. American Society of Anesthesiologists physical status IV and V. 4. Active Do Not Resuscitate (DNR) order. 5. Does not understand written and spoken English well. 6. Anxiety or claustrophobia related to wearing a face mask or nasal c…
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.