European Dyspnoea Survey in the EMergency Departments (EuroDEM)

December 16, 2014 updated by: Said LARIBI, MD, PhD., Hopital Lariboisière

Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms patients can experience; and it is one of the main complaints in the patients presenting to the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac, pulmonary or metabolic etiologies or a combination of them, since several diseases can cause dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary disease (COPD).

Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure (HF) is one of the most important causes of morbidity and mortality in the industrialized world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general European population. The incidence increases rapidly with age, and in Europe. Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to hospital have been adequately described, in Europe and in the United States. The Euro Heart Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively.

This same sensation of breathlessness is what also drives patients with asthma and chronic obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD) exacerbation accounts for approximately 1.5 million ED visits in the United States per year. It is the third most common cause of hospitalization, with an estimated 726 000 hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences between guideline recommendations and actual management of COPD exacerbation, either in the ED or during hospitalization.

The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low sensitivity of the clinical signs associated with the aging of the population and the variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED at the European level. Diagnosis, prevalence and treatment of the patients may vary among European countries.

Study Overview

Status

Completed

Conditions

Detailed Description

MAIN OBJECTIVES

  • Epidemiologic description of patients presenting to the ED with shortness of breath as main complaint.
  • Description of current management in the ED of patients presenting to the ED with shortness of breath as main complaint.

SECONDARY OBJECTIVES

  • Sub analysis of ED discharged patients versus admitted patients for characteristics, comparison to recommended care and re-ED visit.
  • Determine clinical and/or biological criteria to distinguish between:

    • Patients who are treated as outpatients and admitted patients.
    • Patients hospitalized in ward and patients admitted to intensive care units (CCU and ICU)
  • Prognostic prediction, using clinical and biochemical data
  • To determine if ED patients treated for acute heart failure differ from those admitted to hospital.
  • Comparison of European data characteristics, investigation, treatment and outcome to similar data in other part of the world.

Study Type

Observational

Enrollment (Actual)

2156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium
        • Country: Belgium
      • Helsinki, Finland
        • Country: Finland
      • Paris, France
        • Country: France
      • Nuremberg, Germany
        • Country: Germany
      • Rome, Italy
        • Country: Italy
      • Amsterdam, Netherlands
        • Country: Netherlands
      • Cluj Napoca, Romania
        • Country: Romania
      • Santander, Spain
        • Country: Spain
      • Ankara, Turkey
        • Country: Turkey
      • Manchester, United Kingdom
        • Country: United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint during the study period.

Description

Inclusion Criteria:

  • Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint
  • 18 years or older

Exclusion Criteria:

  • No acceptance to participate from the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 30 days
All cause mortality will be evaluated 30 days after ED visit.
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause rehospitalization
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
ED visit
Time Frame: 30 days
New ED visit during follow-up
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Said LARIBI, MD, PhD, Lariboisière Hospital, EuSEM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (Estimate)

February 12, 2014

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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