Evaluation of Rapid Emergency Echography for Acute Dyspnoea for the Diagnosis of Acute Left-sided Heart Failure in Elderly Subjects Admitted to the Emergency Room (READ Protocol)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 10
- 主要终点
- To demonstrate the superiority of the READ method over assessment of NT-proBNP for the diagnosis of acute left-sided heart failure in patients aged ≥75 years admitted to the emergency department for acute dyspnoea.
研究概览
简要总结
Elderly people constitute the largest proportion of emergency room patients, representing 12% of all emergency room admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for emergency room admission, and patients suffering from cardiovascular disease are those whose emergency room visit lasts longest.
The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.
Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.
Some authors have suggested using lung ultrasound in the initial work-up of acute respiratory failure, since some specific profiles are known to be related to the presence of interstitial oedema, reflecting impaired left heart function (e.g. presence of B lines). These studies were performed in the context of intensive or critical care, but data are sparse regarding the application of this approach in the emergency room.
The hypothesis is that the diagnostic accuracy of a targeted and quick echographic approach, namely the READ method (Rapid Echography for Acute Dyspnoea), comprising targeted lung ultrasound combined with isolated measure of transmitral flow, would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the emergency department.
详细描述
The number of emergency room visits is constantly increasing, and it is therefore necessary to minimize the duration of each visit, thereby increasing the efficacy of the diagnostic process, leading to quicker orientation of each patient for appropriate care. In this context, accurate triage and a quick initial diagnostic work-up are of paramount importance in achieving this goal.
Elderly people constitute the largest proportion of emergency room patients, representing 12% of all emergency room admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population, with 4 out of 5 patients requiring such measures. Indeed, elderly persons often suffer from multiple diseases that require a greater number of tests (source: Direction de la recherche, des études, de l'évaluation et des statistiques (DREES), emergency room survey) (1).
Cardiovascular diseases and symptoms represent 12% of the causes for emergency room admission, and patients suffering from cardiovascular disease are those whose emergency room visit lasts longest. Indeed, almost 50% of patients with cardiovascular disease stay more than 4 hours in the emergency room, according to a French national survey published in July 2014.
The diagnostic approach in the emergency room in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis.
Acute dyspnoea and acute respiratory insufficiency are frequent causes of admission to the emergency room. The etiological diagnosis is difficult, especially in elderly patients who often have a history of cardio-respiratory disease (2)(3)(4)(5). In this specific population, there are often numerous comorbidities, such as chronic respiratory failure, chronic renal failure, and ischemic heart disease (6). In addition, acute respiratory insufficiency can be caused by a range of distinct pathologies, such as acute heart failure, pneumonia, exacerbation of chronic obstructive pulmonary disease (COPD), pleural effusion or pulmonary embolism. There is thus clearly a pressing need for an accurate and early diagnosis of the correct etiology in these patients, particularly to identify ALSHF, a condition that requires immediate initiation of appropriate therapy in order to improve prognosis. In these patients, studies have shown that inappropriate or delayed therapy in the emergency room is an independent predictor of death (2)(3)(7).
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
- Single (Care Provider)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the Emergency Department Age ≥ 75 years
- •AND criteria of acute dyspnoea:
- •Breathe rate ≥ 25 cycles/minute
- •or PaO2 ≤ 70 mmHg
- •or SpO2 ≤ 92% in room air
- •or PacO2 ≥ 45 mmHg and pH ≤ 7.35 AND Electrocardiogram in sinus rhythm or in atrial fibrillation at admission
排除标准
- •Shock i.e. : systolic arterial pressure <90mmHg; or reduction >40mmHg or >30% of usual arterial pressure; or Mean Arterial Pressure <65mmHG.
- •Acute respiratory distress ie : Respiratory rate >30cpm, use of accessory respiratory muscles, SpO2 <90% when O2 therapy is required, impaired consciousness,
- •Presence of acute coronary syndrome on the ECG
- •Other obvious etiological diagnosis (pneumothorax, clinical and radiological manifestations of pneumonia)
- •Cardiological or respiratory medicine therapies initiated before the READ approach could be put in place (at patient's home, pre-hospital and/or in the emergency department) i.e.. diuretic, vasoactive drugs (nitrovasodilator, sympathomimetic and cardiotonic drugs, vasodilators and vasoconstrictors); or Continuous Positive Airway Pressure (CPAP); or invasive or non-invasive ventilation.
- •Patient not affiliated to or beneficiary of the French social security system
- •Protected people (pregnant and lactating women, guardianship, curatorship, under the protection of justice)Subjects in the exclusion period after participation in another clinical trial, or as listed in the national database of health research volunteers
结局指标
主要结局
To demonstrate the superiority of the READ method over assessment of NT-proBNP for the diagnosis of acute left-sided heart failure in patients aged ≥75 years admitted to the emergency department for acute dyspnoea.
时间窗: 1 day
The diagnosis of ALSHF will be established post hoc by two experts based on a specialised echocardiography performed within 7 days after inclusion, or before discharge (whichever occurs first) and on the patient's medical file. The presence of ALSHF using the READ method is defined as presence of diffuse B-lines on lung ultrasound, combined with a restrictive pattern on analysis of transmitral profile. A diagnosis of ALSHF will be retained if the NT-proBNP level is greater than the threshold value of 1800 pg/mL, which is the appropriate threshold for patients aged \>75 years.
次要结局
- To evaluate the utility of the combination of the READ method and assessment of NT-proBNP for the diagnosis of ALSHF.(1 day)
- To assess the potential influence of patients characteristics (age, sex, clinical presentation) on the diagnostic performance of each method of diagnosis (READ and NT-proBNP assessment).(1 day)
- To evaluate agreement between the results of the READ approach interpreted immediately in the emergency setting, vs deferred evaluation (outside the emergency setting) of the same images by a different operator.(1 day)