VRI in Children With Acute Respiratory Symptoms.
Recruitment status was Not yet recruiting
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Purpose
The VRI technology provides a radiation free dynamic image of the lung, by using a combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm. The aim of the study is to determine if the VRI examination may contribute to the diagnosis and follow up of pneumonia in children, and therefore reduce the number of chest radiographs and the exposure to ionizing radiation. Children referred by ED for chest x-ray,for the evaluation of pneumonia, will undergo VRI as well. The two modalities will be read independently and then the findings will be compared, in order to asses the potential role of the VRI to the management of pneumonia in children.
| Condition |
|---|
|
Pneumonia Fever |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Vibration Response Imaging (VRI) in Children With Acute Respiratory Symptoms. |
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children, 3-18 years old
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be entered into the study:
- 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:
Any of the following will exclude the patient from study:
- 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;
4. Subject has had lung surgery; 5. Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.
Contacts and Locations| Contact: Liora Kornreich, MD | liorak@post.tau.ac.il |
| Israel | |
| Schneider medical center of Israel, Imaging Department | |
| Petah-Tikva, Israel | |
| Principal Investigator: | Liora Kornreich, MD | Schneider Children's Medical Center, Israel |
| Study Chair: | Gadi Horev, MD | Schneider Children's Medical Center, Israel |
| Study Chair: | Michael Schwarz, MD | Schneider Children's Medical Center, Israel |
| Study Chair: | Osnat Konen, MD | Schneider Children's Medical Center, Israel |
| Study Chair: | Nadine Berkowitz, MD | Schneider Children's Medical Center, Israel |
| Study Chair: | Yehezkel Waisman, MD | Schneider Children's Medical Center, Israel |
More Information
No publications provided
| Responsible Party: | Liora Kornreich, MD, Schneider children's Medical center of Israel |
| ClinicalTrials.gov Identifier: | NCT01279863 History of Changes |
| Other Study ID Numbers: | 5500-DB048 |
| Study First Received: | January 18, 2011 |
| Last Updated: | August 11, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
Pneumonia Cough Shortness of breath VRI |
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 May 19, 2013