European Dyspnoea Survey in the EMergency Departments (EuroDEM)

• ClinicalTrials.gov Identifier: NCT02060799
• Recruitment Status: Completed
• First Posted: February 12, 2014
• Last Update Posted: December 18, 2014
• Sponsor: Hopital Lariboisière
• Information provided by (Responsible Party): Said LARIBI, MD, PhD., Hopital Lariboisière

Study Description

Brief Summary:

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.

Condition or disease
Dyspnea; Emergencies

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 2156 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Official Title: European Dyspnoea Survey in the EMergency Departments
• Study Start Date: February 2014
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: November 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. All cause mortality [ Time Frame: 30 days ]
   All cause mortality will be evaluated 30 days after ED visit.

Secondary Outcome Measures :

1. All cause rehospitalization [ Time Frame: 30 days ]

Other Outcome Measures:

1. ED visit [ Time Frame: 30 days ]
   New ED visit during follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Belgium

Country: Belgium

Brussels, Belgium

Finland

Country: Finland

Helsinki, Finland

France

Country: France

Paris, France

Germany

Country: Germany

Nuremberg, Germany

Italy

Country: Italy

Rome, Italy

Netherlands

Country: Netherlands

Amsterdam, Netherlands

Romania

Country: Romania

Cluj Napoca, Romania

Spain

Country: Spain

Santander, Spain

Turkey

Country: Turkey

Ankara, Turkey

United Kingdom

Country: United Kingdom

Manchester, United Kingdom

Sponsors and Collaborators

Hopital Lariboisière

Investigators

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

More Information

Additional Information:

• Responsible Party: Said LARIBI, MD, PhD., Principal Investigator, Hopital Lariboisière
• ClinicalTrials.gov Identifier: NCT02060799
• Other Study ID Numbers: HLariboisiere
• First Posted: February 12, 2014
• Last Update Posted: December 18, 2014
• Last Verified: December 2014

Keywords provided by Said LARIBI, MD, PhD., Hopital Lariboisière:

Dyspnea; Emergency Service, Hospital; prognosis; Fatal Outcome; Epidemiology

Additional relevant MeSH terms:

Dyspnea; Emergencies; Disease Attributes; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory