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临床试验/NCT07237633
NCT07237633已完成不适用

Evaluating the Feasibility of a Piezoelectric Smart Sensor as an Aid to Help Clinicians Screen for the Development of Pneumonia in an At-risk Population

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年1月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Detection of pneumonia

研究概览

简要总结

This proposed research aims to evaluate the feasibility of the piezoelectric sensor as an aid to help clinicians screen for the development of pneumonia in an at-risk population.

详细描述

This is a proof of concept study to demonstrate that the piezoelectric sensor can be used as an aid to help clinicians screen for the development of pneumonia in at-risk populations (i.e. hospitalized patients with acute stroke and COVID-19 patients). The findings from this study can be extrapolated to the other community settings (e.g. nursing homes, dormitories) where access to healthcare is more limited. The decision to site this study in an acute hospital or community care facility (CTF) is largely pragmatic - easier access to patients; investigations (e.g. chest x-ray, blood tests) and treatment are more readily available for patients without any need for their transfer.

As this is a proof of concept study, the project number of subject required was not based on statistical power calculation. A total of 70 subjects will be recruited. The sample size of 30 participants is a pragmatic decision based on feasibility and is typical for a proof of concept study of this nature.

A total of 70 subjects, including those with acute stroke (with MRI or CT brain evidence of acute stroke) at NUH, those with ESRF (End Stage Renal Failure) on HD (hemodialysis) at NUH, The piezoelectric sensor will be applied to the posterior chest wall (6-point) of the subject at one time point daily (excluding weekends, public holidays and discharge day) up to 2 weeks whilst he/she is warded. CXR (Chest X-Ray) will be performed if the clinician and/or piezoelectric sensor detects abnormal chest sounds that is suggestive of pneumonia or fluid overload.

The piezoelectric sensor will be applied to the skin of the subject at the 6 points on the posterior chest wall for 30 seconds at each position. The piezoelectric sensors will be carefully sterilized with alcohol swaps before and after each placement. The program algorithm will then determine the type of lung sound recorded by the piezoelectric sensors.

CXR will be performed to determine the presence of pneumonia or fluid overload if the clinician and/or piezoelectric smart sensor detects abnormal lung sounds. CXR may not be performed if it is not required based on primary team's clinical assessment.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 21 years and above
  • Acute stroke patients (i.e. MRI or CT brain findings consistent with diagnosis) or ESRF patients on HD who are mentally competent and cognitively fit to provide consent.

排除标准

  • Individuals who are unable to give informed consent
  • Individuals with active dermatological conditions

研究组 & 干预措施

Piezoelectric sensor

Experimental

The piezoelectric sensor will be applied to the posterior chest wall of all recruited subjects once daily at one time point (excluding weekends, public holidays and discharge day) up to 2 weeks whilst he/she is warded, until pneumonia or fluid overload is detected and confirmed by CXR or the subject is discharged, whichever is earlier.

干预措施: Piezoelectric sensor (Device)

结局指标

主要结局

Detection of pneumonia

时间窗: 3 years

The piezoelectric sensor detects abnormal chest sounds that is suggestive of pneumonia or fluid overload and is confirmed by CXR.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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