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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.
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. The piezoelectric sensor will be applied to the posterior chest wall of the subject at one time point daily (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. In the event that the subject declines to have the piezoelectric sensor placed every day, a minimum of 50% of compliance rate is required. If the piezoelectric sensor detects abnormal lung sounds while CXR is normal, the sensor will continue to be placed on the subject daily until CXR confirms pneumonia or fluid overload or the subject is discharged, whichever is earlier. A standard posterior to anterior view CXR will be obtained if the piezoelectric sensor detects abnormal lung sounds and the CXR will be interpreted using a standardized approach.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
National University Hospital
Singapore, Singapore
Start Date
January 18, 2023
Primary Completion Date
December 31, 2025
Completion Date
March 31, 2026
Last Updated
November 20, 2025
50
ESTIMATED participants
Piezoelectric sensor
DEVICE
Lead Sponsor
National University Hospital, Singapore
Collaborators
NCT07371455
NCT06258538
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05093673