Evaluation of Rapid Emergency Echography for Acute Dyspnoea

NCT02531542 | Completed DMC

• 1 other identifier: N/2014/69
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Acute Dyspnea

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 day

Secondary Outcomes (3)

• 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

Study Arms (1)

READ echography

OTHER

Device: Echocardiography according to the READ method.

Interventions

Echocardiography according to the READ method. DEVICE

* Echocardiography will be performed before any therapy is initiated by a fully trained operator, according to the READ method. The results of this ultrasound will not be communicated to the clinician managing the patient in the emergency room. * A blood sample will be taken during the routine work-up for centralized evaluation of NT-proBNP levels.

READ echography

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Centre Hospitalier Germon et Gauthier: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Centre Hospitalier de PAU: collaborator
• University Hospital, Strasbourg, France: collaborator
• Centre Hospitalier Général de Toulon: collaborator

Study Sites (5)

University Hospital of Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63000, France

Location

University Hospital of Strasbourg

Strasbourg, Grand Est, 67000, France

Location

Centre hospitalier de Pau

Pau, Nouvelle-Aquitaine, 64000, France

Location

University Hospital of Toulouse

Toulouse, Occitanie, 31000, France

Location

Centre Hospitalier de Toulon

Toulon, Provence-Alpes-Côte d'Azur Region, 83000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 24, 2015
• Study Start: February 29, 2016
• Primary Completion: December 20, 2022
• Study Completion: December 27, 2022
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

FR (5)