Acute Dyspnea Clinical Trial
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 Protocol)
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.
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).
The European Society of Cardiology (ESC) recently published a review of the standard
diagnostic methods for ALSHF, describing the advantages and limitations of each (clinical
examination, electrocardiogram (ECG), chest x-ray, NT-proBNP assessment) (8).
The clinical signs are difficult to interpret, and are non-specific, particularly at the
acute phase and in elderly or obese patients (9). Indeed, some authors have reported up to
50% of diagnostic errors in elderly patients (10).
Chest x-ray, which is usually performed in the emergency room, is not specific because of
the conditions in which it is performed in emergency situations. Generally, the
pre-requisites for proper implementation are not fully respected because of the emergency
nature of the exam, and chest x-ray is therefore primarily useful for differential diagnosis
only (8).
Early echocardiography is recommended in patients presenting to the hospital in an emergency
with suspected heart failure (HF) and acute onset of symptoms. Imaging techniques play a
central role in the diagnosis of HF and in guiding treatment. Among the several imaging
modalities available, echocardiography is the method of choice in patients with suspected HF
for reasons of accuracy, availability (including portability), safety and cost. The term
echocardiography is used here to refer to all cardiac ultrasound imaging techniques,
including two- or three-dimensional echocardiography, pulsed and continuous wave Doppler,
colour flow Doppler, and tissue Doppler imaging. For assessment of left ventricular systolic
and diastolic dysfunction, no single echocardiographic parameter is sufficiently accurate
and reproducible to be used in isolation. Therefore, a comprehensive echocardiographic
examination incorporating all relevant two-dimensional and Doppler data is recommended. This
should include the evaluation of both structural and functional abnormalities.
However, this type of specialised echocardiography is not routinely available in most
emergency rooms. In routine practice, systematic specialised echocardiography by a
cardiologist for all cases of acute respiratory failure is not feasible due to the lack of
trained operators. Indeed, training in specialised echocardiography is not a pre-requisite
to become a qualified emergency room physician in France. Lastly, specialised
echocardiography exams are time-consuming and incompatible with the need to manage the vast
flow of patients through a busy emergency room.
An alternative approach to diagnosis is to measure the blood concentration of a natriuretic
peptide, a family of hormones secreted in increased amounts when the heart is diseased or
the load on any chamber is increased (11)(12)(13)(14)(15)(16). 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 (17). Diagnostic
performance deteriorates with increasing age, and there is a significant increase in this
grey-zone in patients aged ≥75 years (8)(16)(18)(19). In critical situations in elderly
patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left
heart failure (8)(16)(19).
Some authors have suggested using lung ultrasound in the initial work-up of acute
respiratory failure (20)(21)(22)(23)(24)(25)(26), 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) (27)(28). 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.
In a preliminary, single-centre study, the utility of a quick transthoracic echography
approach was investigated, namely the READ method (Rapid Echography for Acute Dyspnoea),
which associated targeted lung ultrasound and measure of transmitral flow in 51 patients
aged ≥75 years. When performed at the patient's admission to the emergency room, the READ
method was showed to have a sensitivity of 95% for the identification of ALSHF. Indeed,
analysis of transmitral flow is easily available by transthoracic echography. The presence
of a "restrictive" pattern in case of acute dypsnoea is associated with the existence of
ALSHF (29)(30)(31)(32)(33).
Echography is a diagnostic tool whose use in the emergency room is increasing exponentially.
For example, the "Focused Assessment with Sonography in Trauma" (FAST) ultrasound assessment
technique in trauma patients has become the cornerstone of initial triage in trauma
patients. The idea is to use targeted ultrasound, not necessarily performed by a specialist,
to achieve accurate triage of patients in only a few minutes to guide subsequent diagnostic
and therapeutic approaches.
There is a paucity of well-conducted studies in the literature evaluating the utility of
targeted chest ultrasound in the diagnostic work-up of acute dyspnoea in elderly patients
admitted to the emergency department. There currently exists no consensus regarding the use
of echography in these patients, and its use largely depends on the competency and
availability of operators in the emergency, in the absence of formal evidence proving its
utility. Biomarkers such as brain natriuretic peptide (BNP) or NT-proBNP lack sensitivity in
this age-category of patients, although they are widely used in routine practice given the
impossibility of rapid, and 24/7 access to specialised echocardiography.
In this context, the study 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
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