Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vibration Response Imaging in the Diagnosis of Pulmonary Disease
This study is currently recruiting participants.
Verified by Singapore General Hospital, July 2008
Sponsored by: Singapore General Hospital
Information provided by: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00719784
  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

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title: Vibration Response Imaging in the Diagnosis of Pulmonary Disease - an Exploratory Study

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 ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.

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

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore
Contact: Devanand Anantham, FCCP     65 81231130     anantham.devanand@sgh.com.sg    
Principal Investigator: Devanand Anantham, FCCP            
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Devanand Anantham, FCCP Singapore General Hospital
  More Information

Publications of Results:
Responsible Party: Singapore General hospital ( Dr Devanand Anantham )
Study ID Numbers: 147/2008
Study First Received: July 20, 2008
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00719784  
Health Authority: Singapore: Health Sciences Authority

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

Study placed in the following topic categories:
Respiratory Tract Diseases
Lung Diseases
Thoracic Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on January 13, 2009