Clinical Trial: Evaluation of Rapid Emergency Echography for Acute Dyspnoea

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Pr

Brief Summary:

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 perform

Detailed Summary:

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, th
Sponsor: Centre Hospitalier Universitaire de Besancon

Current Primary Outcome: 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. [ Time Frame: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate the utility of the combination of the READ method and assessment of NT-proBNP for the diagnosis of ALSHF. [ Time Frame: 1 day ]
    The diagnostic value of the test, assessed in terms of sensitivity and specificity, will be calculated based on the optimal combination of the results of the two tests, namely the READ method and NT-proBNP assessment.
  • 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). [ Time Frame: 1 day ]
    We will investigate the possible presence of a spectrum effect, mainly in terms of age and gender, in the population.
  • 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. [ Time Frame: 1 day ]
    We will 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 expert operator.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Besancon

Dates:
Date Received: August 12, 2015
Date Started: September 2015
Date Completion: July 2017
Last Updated: August 20, 2015
Last Verified: August 2015