Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms

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: NCT00992966
Recruitment Status : Suspended (Study initiation has been delayed due to Sponsor decision)
First Posted : October 9, 2009
Last Update Posted : August 20, 2010
Information provided by:
Deep Breeze

Brief Summary:
The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed.

Condition or disease

Detailed Description:

This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints.

Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever.

Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device.

A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other.

VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal.

Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR.

The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total number of 80 patients in the age range of 3-18 and consisting of both boys and girls, preferably in an equal distribution

Inclusion Criteria:

  1. Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
  2. Boy or girl in the age range of 3-18 years.
  3. Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
  4. Patient referred by ED physician and presented for CXR.

Exclusion Criteria:

  1. Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
  2. Potentially contagious skin lesion on the back;
  3. Subject has had lung surgery;
  4. Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.

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): NCT00992966

Sponsors and Collaborators
Deep Breeze
Principal Investigator: Liora Kornreich, M.D Shnider medical center
Principal Investigator: Liora Kornreich, Professor Shnider medical center

Responsible Party: Merav Gat / VP Clinical Affairs, Deep Breeze Identifier: NCT00992966     History of Changes
Other Study ID Numbers: DB048
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010

Keywords provided by Deep Breeze:
to acquire database of pneumonia cases in children

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms