Lung Diseases Clinical Trial
Official title:
Vibration Response Imaging in the Diagnosis of Pulmonary Disease - an Exploratory Study
Verified date | February 2017 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Vibration Response Imaging (VRI) is novel technology which records breath sounds via pizo-electric sensors and produces a digital image using a computer algorithm. It is radiation free and is portable to the patient's bedside. Data exists to show that the recordings from normal individuals differs from those who have pulmonary pathology. There is also evidence that recordings have high levels of inter and intra-observer reliability. However, data on specific VRI patterns for specific pathology is still needed before this can be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will be used as the reference gold standard. Other diagnostic modalities that have been used as part of the patient's usual standard of care will also be used for comparison. Specifically breath sound progression, the maximal sound energy shape/distribution and the presence of artifactual sounds will be used to search for patterns that may be used for diagnosis. Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema, bronchiectasis, pneumonia, effusion, pneumothorax, etc)
Status | Completed |
Enrollment | 25 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - All adult ( = 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible. - Children may have too small body sizes for the current standard sensors and will not be recruited. - Other inclusion criteria will be ability to provide informed consent. Exclusion Criteria: - Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions. - The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions. |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. — View Citation
Maher TM, Gat M, Allen D, Devaraj A, Wells AU, Geddes DM. Reproducibility of dynamically represented acoustic lung images from healthy individuals. Thorax. 2008 Jun;63(6):542-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease | At bedsde assessment |
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