Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology in Covid-19 (REMAP-WEST-COV)
A Small-scale Study to Capture Acoustic Pathophysiological Parameters, in the Community, Through a Wearable Device, and to Evaluate the Technical and Practical Feasibility of Utilising This Data as Part of a Medical Device System for the Monitoring and Evaluation of Covid-19 at Home
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever.
10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:
What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device?
The investigators will also consider:
Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)?
These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.
研究概览
详细说明
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology in Covid-19.
DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device in Covid-19.
AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters in Covid-19. To investigate usability and acceptability of the Senti data capture device, and to ensure technical and practical functionality of the device in a real-world clinical scenario.
PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in situ. The ease with which patients can apply the device.
POPULATION ELIGIBILITY: Patients with covid-19 or suspected of having Covid-19 clinically, being discharged home into the community after attending A&E.
DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Merseyside
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Liverpool、Merseyside、英国、L1 0AX
- Senti Tech
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients attending A&E with Covid-19 or suspected Covid-19, who are being discharged from A&E into the community.
Exclusion Criteria:
- Patients unable to give their consent.
- Patients with a known sensitivity or allergy to any of the components of the device.
- Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).
- Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).
- Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 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 |
|---|---|
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实验性的：感知臂
在本研究的第 1 阶段（6 名患者），患者将使用该设备并完成初始患者调查；问题围绕着可用性、舒适度（包括压力感）和可接受性。 调查员将记录应用该设备所花费的时间。 设备上的九个传感器中的每一个都将在三种不同的设置下记录简短的 30 秒胸部声音：站立、躺下、四处走动。 在本研究的第二阶段（10 名患者；其中 6 名将从第一阶段重新招募），参与者将在家中使用该设备五天。 调查员将每天评估参与者是否有压疮迹象或使用该设备引起的并发症（包括局部过敏反应）。 参与者将完成每日调查。 鼓励参与者移除设备并自行决定是否使用它。 参与者可以在任何阶段选择不佩戴该设备。 |
该设备 I 类，CE 标志服装，形状类似于 T 恤，嵌入十个传感器模块，封装在硅胶中；该设备带有衣架形式的充电座。 根据这项可行性研究的结果，该设备在未来可能会成为 IIb 类医疗设备系统的一部分，同时配备基于云的软件，以收听每位 Senti 患者当前和历史记录的呼吸音。 Senti Version One 设备将在衣服内侧清楚地标明设备版本，符合 MDR。 服装本身将由纺织复合材料制成，包括棉、弹性蛋白酶、微模型、氨纶和聚酯。 所有其他组件（包括电子和其他塑料组件）将完全包裹在医用级硅胶中。 |
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 |
|---|---|---|
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患者评价的设备可接受性
大体时间：1个月
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患者问卷“从 1（“我完全不赞成”）到 5（“我非常赞成并希望这成为标准做法”），您在多大程度上赞成使用该设备来启用临床医生评估您的心肺音作为电话咨询的一部分？”
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1个月
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患者评价的设备舒适度
大体时间：1个月
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患者问卷“从 1（“非常难用”）到 5（“非常容易使用”），该设备的易用性如何？”
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1个月
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患者评价的设备易用性
大体时间：1个月
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患者调查问卷“从 1（“使用超过一个小时左右感到不舒服”）到 5（“像 T 恤一样舒适”），该设备的舒适度如何？”
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1个月
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专家级设备数据质量
大体时间：1个月
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一个适当的合格人员（具有听诊临床经验）对设备捕获的数据质量进行评分，与他们通常期望从标准听诊获得的质量进行主观比较，评分为 1（“数据质量比标准听诊差得多]”）到 3（“模棱两可的数据质量”）到 5（“更高的数据质量”）。
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1个月
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Adverse events and adverse device events
大体时间：1 month
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The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported.
Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related.
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1 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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设备在患者身上花费的时间长度。
大体时间：1个月
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患者使用该设备的时间长度，使用结构化的分箱多项选择调查进行测量。
这是一个名为“在过去的 24 小时内，您佩戴 Senti 设备多少小时？”的定制量表。最小值为 0 小时，最大值为 24 小时。
包含时间范围的 8 个选项可供选择。
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1个月
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患者使用该设备所需的时间
大体时间：1个月
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患者戴上设备所用的时间长度，由研究人员用秒表测量。
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1个月
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训练患者使用该设备所花费的时间。
大体时间：1个月
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训练患者使用该设备所花费的时间长度，由研究者用秒表测量。
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1个月
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Pressure sore EPUAP grade
大体时间：1 month
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For those patients who develop pressure sores, the pressure sore will be graded using the European Pressure Ulcer Advisory Panel grading system from a grade of grade 1 through to grade 4, including unclassified gradings and moisture lesions.
(Patients will be graded as "No pressure sores" if there are no pressure sores noted on examination).
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1 month
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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