European Dyspnoea Survey in the EMergency Departments

Dyspnea Clinical Trial

— EuroDEM  

Official title:

European Dyspnoea Survey in the EMergency Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060799
• Other study ID #: HLariboisiere
• Status: Completed
• Phase: N/A
• First received: February 9, 2014
• Last updated: December 16, 2014
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeFinland: National Advisory Board on Health Care EthicsFrance: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeRomania: Ethics CommitteeSpain: Comité Ético de Investigación ClínicaTurkey: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2156
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ED visit	New ED visit during follow-up	30 days	No
Primary	All cause mortality	All cause mortality will be evaluated 30 days after ED visit.	30 days	No
Secondary	All cause rehospitalization		30 days	No