Vibration Response Imaging in the Diagnosis of Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00719784
First received: July 20, 2008
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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)


Condition Intervention
Respiratory Diseases
Pulmonary Diseases
Thoracic Diseases
Lung Diseases
Device: Vibration Response Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Vibration Response Imaging in the Diagnosis of Pulmonary Disease - an Exploratory Study

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease [ Time Frame: At bedsde assessment ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All patients recruited will have VRI recordings done. There is no comparative arm.
Device: Vibration Response Imaging
Recordings will be then performed using the VRI device (Deep Breeze™, Or Akiva, Israel). Forty-two sensors that are assembled on 2 planar arrays will be placed on subject's back. Each row of 3 sensors is held in place by silicone cups that are coupled to the patient's back by a computer-controlled low vacuum seal.
Other Name: Deep Breeze

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00719784

Locations
Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Devanand Anantham, FCCP Singapore General Hospital
  More Information

Publications:
Responsible Party: Dr Devanand Anantham, Singapore General hospital
ClinicalTrials.gov Identifier: NCT00719784     History of Changes
Other Study ID Numbers: 147/2008
Study First Received: July 20, 2008
Last Updated: June 23, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Respiratory
Pulmonary
Thoracic
Chest
Lung

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Diseases

ClinicalTrials.gov processed this record on July 22, 2014