NCT00992966

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

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Deep Breeze · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pneumonia

Timeline

• First posted: 2009-10-09
• Last updated: 2010-08-20