Clinical trial NCT00992966: Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms
Official title: Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Pneumonia
Keywords: to acquire database of pneumonia cases in children
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shnider medical center
name: Liora Kornreich, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shnider medical center
name: Liora Kornreich, Professor
role: PRINCIPAL_INVESTIGATOR
References: