Wearable Wireless Respiratory Monitoring System That Detects and Predicts Opioid Induced Respiratory Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
- Type of surgery and surgeon that routinely orders opioid medications in the PACU, ICU, intermittent ICU, and general wards of TJUH for post-operative pain control.
- Review of the subjects' medical history, surgical history, and current medications.
- Review of the subject's systems to confirm the study subject does not currently have unstable cardiovascular disease, a pulmonary infection, severe asthma, severe bronchitis, or severe emphysema.
- Demographics (year of birth, gender, and race).
- Body Mass Index (BMI) calculation (based on subjects' height and weight).
Informed Consent:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years.
- •BMI < 20 or >
- •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.
研究组 & 干预措施
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.
干预措施: Study to evaluate a Respiratory Monitoring System (RMS) with a Tracheal Sound Sensor (TSS) for detecting and predicting opioid induced respiratory Depression (OIRD). (Device)
结局指标
主要结局
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.
时间窗: 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.
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.
次要结局
- RMS Safety Endpoint(From TSS adhesion on the neck to removal of the TSS for 26+ hours of wear-time.)
- 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).)