- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992966
Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms
Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- Boy or girl in the age range of 3-18 years.
- Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever.
- Patient referred by ED physician and presented for CXR.
Exclusion Criteria:
- 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);
- Potentially contagious skin lesion on the back;
- Subject has had lung surgery;
- Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liora Kornreich, M.D, Shnider medical center
- Principal Investigator: Liora Kornreich, Professor, Shnider medical center
Study record dates
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
- DB048
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.
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