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临床试验/NCT01279863
NCT01279863Unknown不适用

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

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1

研究概览

简要总结

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.

详细描述

Background Several widely used imaging modalities are available today for the human lung. Conventional radiology, CT, and to a lesser extent MRI, as well as nuclear medicine in some indications are well established and most commonly used. Methods using acoustic signals, most notably ultrasound, have not been successfully developed. This is primarily due to the fact that the acoustic damping of the lung parenchyma is prohibitively high at high frequencies .

Assessment of alterations in the structure and function of thoracic organs that occur in disease often gives rise to measurable changes in lung sound production and transmission. Acoustic assessment with a stethoscope is a commonly used method to assess these structural and functional changes. However, auscultation with a stethoscope has many limitations. It is a subjective process that depends on the individual's own hearing, experience and ability to differentiate between different sound patterns. In addition, quantitative measurements and documentation are not easy to be produced. Moreover, the stethoscope has a frequency response that attenuates frequency components of the lung sound signal above 120Hz, and the human ear is not very sensitive to the lower frequency band.

Analysis of acoustic sounds by computer is more likely to be successful in clinical applications when it is based on mathematical models of the underlying physical mechanisms of respiratory sound production. Such models allow for the interaction of mechanical forces, airflow and sound transmission within the respiratory tract to be understood and related to the different disease processes.

The VRI technology, to the best of our knowledge, is the first of its kind to provide a radiation free dynamic image of the lung, by using a combination of well-known technologies, i.e. acoustic sensors, and a proprietary algorithm.

Since the acoustic response of a body depends on its structural properties, complex structures can exhibit acoustic responses, which may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected by a corresponding modification of the acoustic response.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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;
  • Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms.

研究者

申办方类型
Other

研究点 (1)

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VRI in Children With Acute Respiratory Symptoms. | 临床试验