Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has suspended participant recruitment.
(Study initiation has been delayed due to Sponsor decision)
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00992966
First received: October 8, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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
Pneumonia

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

Resource links provided by NLM:


Further study details as provided by Deep Breeze:

Estimated Enrollment: 80
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.

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992966

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

No publications provided

Responsible Party: Merav Gat / VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT00992966     History of Changes
Other Study ID Numbers: DB048
Study First Received: October 8, 2009
Last Updated: August 19, 2010
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 27, 2014