Vibration Response Imaging in the Diagnosis of Pulmonary Disease - an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease
研究概览
简要总结
Vibration Response Imaging (VRI) is novel technology which records breath sounds via pizo-electric sensors and produces a digital image using a computer algorithm. It is radiation free and is portable to the patient's bedside. Data exists to show that the recordings from normal individuals differs from those who have pulmonary pathology. There is also evidence that recordings have high levels of inter and intra-observer reliability. However, data on specific VRI patterns for specific pathology is still needed before this can be used as a diagnostic tool. We aim to perform an open label feasibility trial on inpatient and outpatient pulmonary patients. Bedside clinical examination and chest auscultation will be used as the reference gold standard. Other diagnostic modalities that have been used as part of the patient's usual standard of care will also be used for comparison. Specifically breath sound progression, the maximal sound energy shape/distribution and the presence of artifactual sounds will be used to search for patterns that may be used for diagnosis. Sensitivity and specificity will be calculated for each disease (eg. asthma, emphysema, bronchiectasis, pneumonia, effusion, pneumothorax, etc)
详细描述
Introduction:
The measurement of regional distribution of breath sound intensity within the human thorax during respiration using computerized lung sound analysis has generated interest as a possible diagnostic modality. Using normal breath sound distribution as a reference, abnormal distributions of sound energy can be used to identify potential pathological states. Vibration Response Imaging (VRI) utilizes such technology.
VRI processes lung sound recordings and generates a dynamic representation of this sound energy distribution on a computer screen using a grey-scale coding. Air turbulence within the airways and the consequent vibrations that are generated are captured by multiple piezoelectric contact sensors, which have been placed on the skin of the patient. The signals are processed by band-pass (150-250 Hz) filtering to eliminate heart sounds and chest wall movements. These filtered signals are then combined, sliced over 0.17 second intervals, and converted into a sequence of dynamic images that reflect regional sound vibration energies against a time axis. Lung vibration energy is presented on the screen in various grey shades from black in maximum energy areas to white in zero energy areas. Pilot data suggest that VRI can distinguish breath sounds in normal patients from those with intra-thoracic pathology based on distinctive patterns of vibration energy. Reproducibility of VRI recordings and consistency of inter-observer interpretation have also been documented.
Aim:
To assess the diagnostic capability of Vibration Response Imaging (VRI) in the evaluation of pulmonary disease (Subjects presenting as pulmonary inpatients and outpatients). Chest auscultation and other diagnostic modalities that have been used as part of standard of care (eg. chest radiograph, CT scans and thoracic ultrasound) will be used as the reference gold standard to compare against.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult ( ≥ 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible.
- •Children may have too small body sizes for the current standard sensors and will not be recruited.
- •Other inclusion criteria will be ability to provide informed consent.
排除标准
- •Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions.
- •The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions.
结局指标
主要结局
Diagnostic accuracy of Vibration Response Imaging in Pulmonary Disease
时间窗: At bedsde assessment
次要结局
未报告次要终点