Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 530
- 试验地点
- 8
- 主要终点
- Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc).
研究概览
简要总结
For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission.
The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide Informed Consent;
- •>40 years of age;
- •Estimated Body Mass Index >19;
- •Patient presented to the emergency department with a chief complaint of acute dyspnea.
排除标准
- •Patients with obvious trauma or acute anxiety as a cause of dyspnea;
- •Patient has already received directed therapy in the ED and symptoms are remarkably improved;
- •Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing;
- •Intubated or mechanically ventilated;
- •Acute hemodynamic or ventilator instability requiring immediate resuscitation;
- •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);
- •Hirsutism.
结局指标
主要结局
Assess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc).
时间窗: Baseline testing at ED presentation
The primary efficacy analysis set (PEAS) consists of all patients who have Gold Standard (GS) diagnosis (CHF/non-CHF) \& VRI records. * Accuracy rate is defined as the accuracy between the GS and VRI. * Accuracy parameters between the GS and VRI will be calculated using accuracy rate, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) \& likelihood ratios (+,-).
次要结局
- Assess the agreement to aid in classifying the cause of acute dyspnea as HF or other of the VRI in comparison to BNP/NTproBNP assays.(Baseline testing at ED presentation)
- Evaluate the ability of the VRI to monitor changes in clinical status following treatment in comparison with other standard testing methods (e.g. ECG, serial chest x-rays, etc.)(Baseline testing and repeated testing after 2 hours)
- Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD(Baseline testing at ED presentation)