Vibration Response Imaging in the Diagnosis of Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00719784
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Diseases Pulmonary Diseases Thoracic Diseases Lung Diseases Device: Vibration Response Imaging Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vibration Response Imaging in the Diagnosis of Pulmonary Disease - an Exploratory Study
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease [ Time Frame: At bedsde assessment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00719784

Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Principal Investigator: Devanand Anantham, FCCP Singapore General Hospital

Publications of Results:
Responsible Party: Singapore General Hospital Identifier: NCT00719784     History of Changes
Other Study ID Numbers: 147/2008
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Singapore General Hospital:

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