VRI in Children With Acute Respiratory Symptoms.

NCT01279863 | Unknown

• 1 other identifier: 5500-DB048
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Fever

Keywords

Pneumonia; Cough; Shortness of breath; VRI

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children, 3-18 years old

You may qualify if:

• 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.

You may not qualify if:

• 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;
• \. 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider medical center of Israel, Imaging Department

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Pneumonia; Fever; Cough; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Liora Kornreich, MD

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Liora Kornreich, MD

CONTACT

liorak@post.tau.ac.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 12, 2011

Record last verified: 2010-05

Locations

IL (1)