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Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department (EMERALD-US)

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ClinicalTrials.gov Identifier: NCT03691857
Recruitment Status : Not yet recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Dyspnea Procedure: Ultrasound algorithm (EMERALD-US) Not Applicable

Detailed Description:

The investigators aim to assess the feasibility and accuracy of a new pragmatic and original ultrasound algorithm adapted for acute dyspnea diagnosis in the emergency department.

This primary objective of this prospective multicenter study is 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) in patients with acute non-traumatic dyspnea managed in the emergency department. Ultrasound exams will be blindly read by a centralized core laboratory after the standardized acquisition of all exams by a physician not involved in the care of patients in the ED. The main discharge diagnosis from initial hospitalization (heart failure, pneumonia and obstructive pulmonary disease exacerbation) will be adjudicated by a college of 3 senior physicians (emergency physician, cardiologist and internist) blinded to the use of ultrasound in the ED.

The secondary objectives of the study are to:

A/ Assess the feasibility of the ultrasound algorithm (EMERALD-US) in emergency departments.

B/ Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional (laboratory and radiological exams.

C/ Assess the diagnostic accuracy of the ultrasound algorithm (EMERALD-US) for less frequent dyspnea causes (pulmonary embolism, pleural effusion).

D/ Assess, the diagnostic accuracy of clinical (including BREST score), laboratory and radiological variables.

E/ Assess, the improvement in diagnosis accuracy with the ultrasound algorithm (EMERALD-US) on top of the diagnostic accuracy of clinical, laboratory and radiological exams.

F/ Assess the association between misdiagnosis (without using ultrasound) and survival at D30.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Feasibility and Accuracy of an Ultrasound Algorithm for Acute Dyspnea Diagnosis in the Emergency Department
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Acute non-traumatic dyspnea patients
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)
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.




Primary Outcome Measures :
  1. Main discharge diagnosis (heart failure, pneumonia and obstructive pulmonary disease exacerbation) [ Time Frame: an average of 2 weeks (from date of admission in the emergency department until the date of hospitalization discharge) ]
    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


Secondary Outcome Measures :
  1. Duration of the ultrasound examination [ Time Frame: up to 30 minutes ]
    Duration of the ultrasound examination is defined by the delay between the first and last contact between the ultrasound probe and the patient

  2. Proportion of complete realization of the ultrasound algorithm [ Time Frame: up to 30 minutes ]
    Proportion of complete realization of the ultrasound algorithm through study completion

  3. 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 [ Time Frame: At baseline ]
    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

  4. Patient management time in the emergency department [ Time Frame: An average of 24 hours (Time between the time of entry to the emergency department and the time of discharge). ]
    Patient management time in the emergency department is defined by the time between the time of entry to the emergency department and the time of discharge specified in the patient's medical report.

  5. Brain Natriuretic Peptide (BNP) or N-terminal pro-brain natriuretic peptide concentration [ Time Frame: At admission in the emergency department ]
    Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional laboratory exams. NT pro BNP will be measured from the biobanking.

  6. C Reactive protein and procalcitonin concentration, [ Time Frame: At admission in the emergency department ]
    Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local laboratory exams

  7. D-dimer concentration, [ Time Frame: At admission in the emergency department ]
    Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local laboratory exams

  8. Radiological diagnosis (chest X-ray or chest CT). [ Time Frame: At admission in the emergency department ]
    Assess the association between the diagnosis obtained from the ultrasound algorithm (EMERALD-US) and the results of additional local radiological exams

  9. Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians [ Time Frame: An average of 2 weeks (from date of admission in the emergency department until the date of discharge) ]
    Main discharge diagnosis including combined diagnosis (e.g. heart failure and pneumonia) from initial hospitalization adjudicated by a college of 3 senior physicians

  10. All-cause mortality at D30. [ Time Frame: At Day 30 ]
    Assess the association between misdiagnosis (without using ultrasound) and survival at D30



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691857


Contacts
Contact: Tahar CHOUIHED, MD 383851496 ext 0033 t.chouihed@chru-nancy.fr

Locations
France
CH de Chalons en Champagne Not yet recruiting
Châlons-en-Champagne, France, 51000
Contact: Alice PENINE, MD         
Principal Investigator: Alice PENINE, MD         
CH de Colmar Not yet recruiting
Colmar, France, 68000
Contact: Yannick GOTTWALES, MD         
Principal Investigator: Yannick GOTTWALES, MD         
CHU de Dijon - Hôpital Bocage Not yet recruiting
Dijon, France, 21000
Contact: Aurélie AVONDO, MD         
Principal Investigator: Aurelie AVONDO, MD         
CHR de Metz-Thionville - Hôpital Mercy Not yet recruiting
Metz, France, 57000
Contact: Elies ANDRE, MD         
Principal Investigator: Elies ANDRE, MD         
CHRU Nancy Not yet recruiting
Nancy, France, 54500
Contact: Tahar CHOUIHED, MD         
Principal Investigator: Tahar CHOUIHED, MD         
CH de Sarreguemines Not yet recruiting
Sarreguemines, France, 57200
Contact: Emmanuelle SERIS, MD         
Principal Investigator: Emmanuelle SERIS, MD         
CH de Lucien Hussel Not yet recruiting
Vienne, France, 38200
Contact: Carlos ELKHOURY, MD         
Principal Investigator: Carlos ELKHOURY, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Study Chair: Tahar CHOUIHED, MD Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03691857     History of Changes
Other Study ID Numbers: 2018-A02136-49
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emergencies
Dyspnea
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms