Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Investigators will enroll 493 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask or nasal cannula, and will be on continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). Research personnel will screen and select subjects for this study. The CRA will ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival at the PACU, each subject will be fitted with a supplemental oxygen mask or nasal cannula containing the Linshom sensor, which will be connected to Linshom Cyber G-15 monitor for data collection. A pulse oximeter will be applied to the hand (non-NIBP arm), which will be connected to a hospital monitor (SOC). The Linshom G-15 monitor will collect data every 100 milliseconds. The Linshom CPRM will automatically initiate baseline data capture. The CRA will begin recording any clinical interventions (e.g., medications and stimulation upon detection of changes in patient's condition) that are performed by the PACU staff, paying close attention to time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. After data collection, the Linshom engineers will retrieve the data from all monitors and time-sync all data collected from each patient (Linshom CPRM and pulse oximetry). Manually recorded data regarding the time points at which clinical interventions were provided by the PACU staff will also be reviewed and those time points will be noted as RDEs.
The Linshom CPRM system monitors the distinct metric of RDE occurrence. Throughout a given patient's stay, nurses will be provided with two distinct cues (each cue comprised of an auditory and visual component), 1 from CPRM, 1 from SoC, alerting them to a patient's respiratory state. In addition, clinical staff will have access to a summary metrics of critical parameters and RDE occurrences on the Linshom monitor (total RDE count, time since last RDE).
研究概览
地位
详细说明
Linshom has developed the Continuous Predictive Respiratory Monitoring (CPRM) system, designed to alert clinicians of active or impending respiratory distress events. The system features a miniaturized version of the FDA cleared Linshom Continuous Predictive Respiratory Sensor - a small, wearable sensor that provides continuous real-time tracking of the critical indicators of RDE. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care. The technology is based on a novel thermal sensor which is regulated by a thermo-electric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patients inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, rTV, rMV, SSLB, apnea detection, and I/E ratio. The CPRM system solves the unmet need for a small, portable, sensor and monitor that tracks RR, rTV, rMV, seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness.
The main focus will be performing an unblinded trial where the CPRM system is actively used to guide clinical intervention with the aim of reducing burden of RDEs, which will provide critical evidence of the clinical care and health economic cost benefits of the CPRM system.
Specific aim:
Conduct an unblinded clinical trial to demonstrate that Linshom CPRM + standard of care (SOC) can reduce Respiratory Depression Episodes by at least 30% compared to SOC alone.
Outcome: Demonstrate that the CPRM system can reduce the frequency and length of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：James R Hughen, MBA
- 电话号码：443-994-1448
- 邮箱：rhughen@linshommedical.com
研究联系人备份
- 姓名：Ronen Feldman, BS
- 电话号码：443-472-6188
- 邮箱：rfeldman@linshommedical.com
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21230
- Linshom Medical, Inc.
-
接触：
- James R Hughen, MBA
- 电话号码：443-994-1448
- 邮箱：rhughen@linshommedical.com
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接触：
- Ronen Feldman, BS
- 电话号码：443-472-6188
- 邮箱：rfeldman@linshommedical.com
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Ohio
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Columbus、Ohio、美国、43210
- Ohio State University Wexner Medical Center
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接触：
- Richard D Urman, MD, MBA
- 电话号码：614-293-5188
- 邮箱：richard.urman@osumc.edu
-
接触：
- Alberto Uribe, MD
- 电话号码：614-293-3559
- 邮箱：alberto.uribe@osumc.edu
-
首席研究员：
- Richard D Urman, MD, MBA
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- At least 18 years of age undergoing non-cardiac surgery
- Post-operative patients admitted to the post-anesthesia care unit (PACU) and expected to stay in the hospital for at least overnight.
- Receiving supplemental oxygen via face mask or nasal cannula in the PACU
- On continuous SpO2 saturation monitoring
- Receiving standard postoperative care
Exclusion Criteria:
- Requirement for any form of postoperative invasive ventilatory support
- Patients receiving only local or topical anesthesia
- Day/outpatient surgery
- Unable to cooperate with the application of the study device
- Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Post surgical (non-cardiac) PACU patients with anticipated overnight stay.
The intervention will be the institutional standard of care (SOC) intervention(s) for any patient experiencing a RDE (typically an apnea ≥ 30 seconds). Typical interventions may include patient arousal, patient re-positioning, supplemental oxygen administration and other SOC. Inclusion Criteria:
Exclusion Criteria:
|
Linshom CPRM with alarms enabled will be used to alert nurses of respiratory issues.
Action will be taken based on nurse assessment and will follow standard of care procedures.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure the number of Respiratory Depression Events (RDE) of Linshom CPRM + standard of care (SOC) vs. SOC alone.
大体时间：12 months
|
Demonstrate that the CPRM system can reduce the frequency of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical test to be used is a negative binomial regression model, which is appropriate for modeling count data (RDE rates) with potential overdispersion. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure the length (in seconds) of RDE per patient with Linshom CPRM + standard of care (SOC) vs. SOC alone.
大体时间：12 months
|
Demonstrate that the CPRM system can reduce the length of RDE events more effectively than SOC alone (continuous pulse oximetry and 1 on 1 nursing care) when utilized as an alert system by nursing staff. The statistical tests will evaluate: Mean/Median Time Per RDE. |
12 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Measure the Mean/Median Cumulative RDE Time Per Patient in Linshom + SOC vs. SOC alone.
大体时间：12 months.
|
Demonstrate that Linshom Medical + SOC can reduce the Mean/Median Cumulative RDE Time Per Patient vs. SOC alone.
|
12 months.
|
合作者和调查者
调查人员
- 首席研究员：Richard D Urman, MD, MBA、Ohio State University
- 研究主任：Alberto Uribe, MD、Ohio State University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SB1HL182474 (美国 NIH 拨款/合同)
- 1SB1HL182474-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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