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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Patient-rated device acceptability
研究概览
简要总结
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patient's chest, 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.
10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A&E into the care of the community respiratory team. 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: 4. Does the device function technically and practically, in real-world clinical scenarios? 5. 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.
详细描述
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology.
DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device.
AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters. - 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 being discharged home with community respiratory team support, after attending A&E.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patients attending A&E who are being discharged from A&E into the care of the community respiratory team.
排除标准
- •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).
结局指标
主要结局
Patient-rated device acceptability
时间窗: 1 month
Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?"
Patient-rated device comfort
时间窗: 1 month
Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?"
Patient-rated device ease of use
时间窗: 1 month
Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?"
Expert-rated device data quality
时间窗: 1 month
An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality \[than standard auscultation\]") to 3 ("equivocal data quality") to 5 ("Much higher data quality").
Adverse events and adverse device events.
时间窗: 1 month
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.
次要结局
- Length of time spent with the device on the patient.(1 month)
- Length of time taken for the patient to apply the device(1 month)
- Time spent to train patients to use the device.(1 month)
- Pressure sore EPUAP grade(Through study completion, once per day.)