Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 530
- 试验地点
- 4
- 主要终点
- Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients
研究概览
简要总结
For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.
详细描述
Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea.
Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology ("LUS-implemented" diagnosis). All patients will then undergo CXR.
In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available.
After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case.
Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "Positive" and "negative" results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute dyspnea as chief complaint
- •presence of an emergency physician skilled in lung ultrasound at evaluation time
排除标准
- •mechanical ventilation ongoing at enrolment time
- •dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
结局指标
主要结局
Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients
时间窗: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours.
Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available).
次要结局
未报告次要终点
研究者
Enrico Lupia, MD, PhD
Assistant Professor
University of Turin, Italy