Evaluation of the Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 11
- 主要终点
- Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation)
研究概览
简要总结
The management of chest pain has revolutionized its prognosis, primarily by improving urgent diagnosis of myocardial infarction. Currently, acute dyspnea is twice as frequent as chest pain and its associated mortality is much higher (16% of acute dyspnea admitted to emergency departments (ED) ).
Inappropriate treatment of acute dyspnea in the ED is frequent (30%) and is associated with a tripling of intra-hospital mortality after adjustment for confounding factors (2.83, IC 1.48 to 5.41, p=0.002). Other elements have also highlighted the importance of a quick and appropriate acute dyspnea diagnosis:
- The 2015 European Guidelines on acute heart failure emphasize the need for appropriate treatment within 90 minutes after the first medical contact.
- Inadequate treatment of chronic bronchitis decompensation is associated with a doubling of intra-hospital mortality.
- An initiation of antibiotic treatment within 4 hours of admission for pneumonia is recommended.
- 30% of pulmonary embolisms are not diagnosed during the initial emergency department visit, whereas their mortality in the absence of treatment is 25%.
Lung, venous and (simplified) cardiac ultrasound is associated with improved diagnostic performance in ED. However, no ultrasound algorithm dedicated to emergency physicians has been formally validated. The Blue Protocol (Lichtenstein et al., Chest 2008) has been validated in intensive care patients with very different phenotypes than those admitted to the ED. Pivetta et al. (Chest 2015) proposed an algorithm focused solely for the diagnosis of heart failure, thus not providing a diagnosis for all the other causes of dyspnea in ED. Finally, Zanbonetti et al. (Chest 2017) proposed an "unguided" ultrasound use, notably integrating inferior vena cava evaluation. However, measuring the inferior vena cava is difficult at the start of ED management when patients are in acute respiratory distress.
详细描述
The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department.
This primary objective of this prospective multicenter study is to assess the diagnostic accuracy of an ultrasound algorithm (EMERALD-US) dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED.
The secondary objectives of the study are to:
A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments.
B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 50 years old
- •Patients with non-traumatic acute dyspnea managed in the emergency department
- •Patients affiliated with a social security system
排除标准
- •Patients in cardiac arrest
- •Patients in persistent shock
- •Patients with impaired consciousness (Glasgow Score<9)
- •Patients with a history of thoracic surgery or pulmonary fibrosis
- •Patients with Acute Coronary Syndrome with ST elevation
- •Known current pregnancy
- •Patients under guardianship, trusteeship or legal protection
结局指标
主要结局
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation)
时间窗: an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge)
Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation) adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the emergency department
次要结局
- C Reactive protein and procalcitonin concentration,(At admission in the emergency department)
- Duration of the ultrasound examination(up to 30 minutes)
- Radiological diagnosis (chest X-ray or chest CT).(At admission in the emergency department)
- Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians(An average of 2 weeks (from date of admission in the emergency department until the date of discharge))
- Proportion of complete realization of the ultrasound algorithm(up to 30 minutes)
- Brain Natriuretic Peptide (BNP) or N-terminal pro-brain natriuretic peptide concentration(At admission in the emergency department)
- Diagnosis given by the algorithm after core-lab reading of the blinded ultrasound compared to the diagnosis provided by the emergency physician based on the EMERALD algorithm in the emergency department(At baseline)
- Patient management time in the emergency department(An average of 24 hours (Time between the time of entry to the emergency department and the time of discharge).)
- D-dimer concentration,(At admission in the emergency department)
- All-cause mortality at D30.(At Day 30)
研究者
CHOUIHED Tahar
Study chair
Central Hospital, Nancy, France