NCT00719784

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

July 20, 2008

Last Update Submit

February 8, 2017

Conditions

Respiratory DiseasesPulmonary DiseasesThoracic DiseasesLung Diseases

Keywords

RespiratoryPulmonaryThoracicChestLung

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease

    At bedsde assessment

Study Arms (1)

1

EXPERIMENTAL

All patients recruited will have VRI recordings done. There is no comparative arm.

Device: Vibration Response Imaging

Interventions

Vibration Response ImagingDEVICE

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.

Also known as: Deep Breeze
1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (2)

  • 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. doi: 10.1136/thx.2007.086405. Epub 2007 Nov 16.

    PMID: 18024534RESULT

  • 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. doi: 10.1159/000103558. Epub 2007 Jun 4.

    PMID: 17551264RESULT

MeSH Terms

Conditions

Respiratory Tract DiseasesLung DiseasesThoracic Diseases

Study Officials

  • Devanand Anantham, FCCP

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2008

First Posted

July 22, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

SG(1)