- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00672893
Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.
As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13274
- Hospital St. Marguerite
-
-
-
-
-
Heidelberg, Germany, D-69126
- Thoraxklinik at Heidelberg University
-
-
-
-
Kanagawa
-
Kawasaki, Kanagawa, Japan, 216-8511
- St. Marianna Hospital
-
-
-
-
Colorado
-
Denver, Colorado, United States, 80602
- National Jewish Medical and Research Center
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
- Male or female in the age range of 18-85 years.
- Body Mass Index >20.
- Patient presented with airway obstruction and who are designated to undergo intervention
Exclusion Criteria:
- Chest wall deformity;
- Spine deformity (including severe scoliosis or kyphosis);
- Hirsutism;
- Potentially contagious skin lesion on the back;
- Skin lesion that would interfere with sensor placement;
- Patient is pregnant;
- Cardiac pacemaker or implantable defibrillator;
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observation
Patients who present to the clinic with airway obstruction and who are designated to undergo intervention
|
12 seconds of recording lung sounds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.
Time Frame: Baseline and follow-up up to 3 months
|
Baseline and follow-up up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary objective is to assess the contribution of the VRI in aiding in identification of the pulmonary obstruction as compared to the standard methods prior the intervention procedure.
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heinrich D Becker, M.D., Thoraxklinik at Heidelberg University School of Medicine
Publications and helpful links
General Publications
- 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.
- Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DB035-Multi-site
- DB020-Single-site
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Central Airway Stenosis
-
Duke UniversityCompletedCentral Airway Stenosis | Disorder Related to Lung Transplantation | Airway Exudative Plaques | Airway Complications Post-Lung TransplantationUnited States
-
Futian People's HospitalScience and Technology Innovation Commission of Shenzhen MunicipalityUnknownCentral Airway Stenosis | Noninvasive Positive Pressure Ventilation; | Sedation; | Bronchoscopy; | Interventional;China
-
Guangzhou Institute of Respiratory DiseaseUnknownBenign Airway StenosisChina
-
Guangzhou Institute of Respiratory DiseaseRecruitingRespiratory Tract Fistula | Benign Airway StenosisChina
-
University Hospital, ToulouseRecruiting
-
University of Cape TownRed Cross War Memorial Children's HospitalUnknownPediatric Respiratory Diseases | Tracheal Stenosis | Airway DiseaseSouth Africa
-
Beth Israel Deaconess Medical CenterMedWaves, IncRecruitingAirway Obstruction | Central Airway ObstructionUnited States
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingEsophageal Atresia | Tracheoesophageal Fistula | Tracheal Stenosis | Laryngeal Cleft | Bronchial Stenosis | Esophageal Bronchus | Congenital High Airway Obstruction SyndromeUnited States
-
Airiver Medical, Inc.Libra MedicalRecruitingCentral Airway ObstructionGeorgia
-
Brigham and Women's HospitalNot yet recruiting
Clinical Trials on Vibration Response Imaging
-
M.D. Anderson Cancer CenterDeep BreezeCompleted
-
Singapore General HospitalCompletedLung Diseases | Thoracic Diseases | Pulmonary Diseases | Respiratory DiseasesSingapore
-
King Saud UniversityCompleted
-
Georgia State UniversityTerminatedFalls PreventionUnited States
-
Istanbul Physical Medicine Rehabilitation Training...Completed
-
Bagcilar Training and Research HospitalUnknownEffects of Vibration
-
Bagcilar Training and Research HospitalCompletedEffects of Vibration
-
Bagcilar Training and Research HospitalWithdrawnEffects of VibrationTurkey
-
Medical University of South CarolinaNational Institute of General Medical Sciences (NIGMS)Completed
-
Hacettepe UniversityCompleted