Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department

NCT03691857 | Recruiting

• 1 other identifier: 2018-A02136-49
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

• Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation)

  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

  an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge)

Secondary Outcomes (10)

• Duration of the ultrasound examination

  up to 30 minutes

• Proportion of complete realization of the ultrasound algorithm

  up to 30 minutes

• 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).

• Brain Natriuretic Peptide (BNP) or N-terminal pro-brain natriuretic peptide concentration

  At admission in the emergency department

Study Arms (1)

Acute non-traumatic dyspnea patients

OTHER

Patients with acute non-traumatic dyspnea managed in the emergency department 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)

Procedure: Ultrasound algorithm (EMERALD-US)

Interventions

Ultrasound algorithm (EMERALD-US) PROCEDURE

Ultrasound algorithm EMERALD-US is an 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. The ultrasounds will be performed within first hour after first medical contact in emergency department by another emergency physician not in charge of the patient. The ultrasound results will be not shared with the emergency physician in charge of the patient.

Acute non-traumatic dyspnea patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 50 years old
• Patients with non-traumatic acute dyspnea managed in the emergency department
• Patients affiliated with a social security system

You may not qualify if:

• 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
• Dementia
• Patients with Acute Coronary Syndrome with ST elevation
• Known current pregnancy
• Patients under guardianship, trusteeship or legal protection

Sponsors & Collaborators

• CHOUIHED Tahar: lead

Study Sites (7)

CH de Chalons en Champagne

Châlons-en-Champagne, 51000, France

RECRUITING

Hôpital Simone Veil

Eaubonne, 95602, France

RECRUITING

CHRU Nancy

Nancy, 54500, France

RECRUITING

AP-HP - Hôpital Cochin

Paris, France

RECRUITING

AP-HP - Hôpital Lariboisière

Paris, France

RECRUITING

CH de Sarreguemines

Sarreguemines, 57200, France

WITHDRAWN

CHRU de Strasbourg, Hôpital de Hautepierre

Strasbourg, France

RECRUITING

Related Publications (1)

• Jaeger D, Duchanois C, Duarte K, Lepage X, Merckle L, Bassand A, Buessler A, Chauvin A, Bokobza J, Penine A, Giacomin G, Brossard C, Girerd N, Chouihed T. Performance of an ultrasound diagnostic algorithm for acute dyspneic patients in the emergency department: an EMERALD-US protocol. BMJ Open. 2025 Aug 10;15(8):e101432. doi: 10.1136/bmjopen-2025-101432.

  PMID: 40784781 DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tahar CHOUIHED, MD

  Central Hospital, CHRU de Nancy, France

  PRINCIPAL INVESTIGATOR

• Nicolas GIRERD, MD PhD

  CHRU de Nancy, France

  STUDY CHAIR

• Patrick ROSSIGNOL, MD PhD

  CHRU de Nancy, France

  STUDY CHAIR

Central Study Contacts

Tahar CHOUIHED, MD

CONTACT

(0)3 83 85 14 96; t.chouihed@chru-nancy.fr

Nicolas GIRERD, MD PhD

CONTACT

n.girerd@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study chair

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 2, 2018
• Study Start: December 14, 2020
• Primary Completion: March 14, 2025
• Study Completion: April 14, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)