EUROpean Dyspnoea Survey in the EMergency Departments (EURODEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hopital Lariboisière
Sponsor:
Collaborator:
European Society for Emergency Medicine
Information provided by (Responsible Party):
Said LARIBI, MD, PhD., Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT02060799
First received: February 9, 2014
Last updated: February 15, 2014
Last verified: February 2014
  Purpose

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
Dyspnea
Emergencies

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: EUROpean Dyspnoea Survey in the EMergency Departments

Resource links provided by NLM:


Further study details as provided by Hopital Lariboisière:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    All cause mortality will be evaluated 30 days after ED visit.


Secondary Outcome Measures:
  • All cause rehospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • ED visit [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    New ED visit during follow-up


Estimated Enrollment: 2500
Study Start Date: February 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060799

Contacts
Contact: Said LARIBI, MD, PhD. +33 1 49 95 63 91 said.laribi@lrb.aphp.fr

Locations
Belgium
Country: Belgium Recruiting
Brussels, Belgium
Contact: Franck Verschuren, MD, PhD         
Principal Investigator: Franck Verschuren, MD, PhD         
Finland
Country: Finland Recruiting
Helsinki, Finland
Contact: Veli-Pekka Harjola, MD, PhD         
Principal Investigator: Veli-Pekka Harjola, MD, PhD         
France
Country: France Recruiting
Paris, France
Contact: Said LARIBI, MD, PhD    +33 1 49 95 63 91      
Principal Investigator: Said Laribi, MD, PhD         
Germany
Country: Germany Recruiting
Nuremberg, Germany
Contact: Michael Christ, MD, PhD         
Principal Investigator: Michael Christ, MD, PhD         
Italy
Country: Italy Recruiting
Rome, Italy
Contact: Cinzia Barleta, MD         
Principal Investigator: Cinzia Barleta, MD         
Netherlands
Country: Netherlands Not yet recruiting
Amsterdam, Netherlands
Contact: Oene Van Meer, MD         
Principal Investigator: Oene Van Meer, MD         
Romania
Country: Romania Recruiting
Cluj Napoca, Romania
Contact: Adela Golea, MD, PhD         
Principal Investigator: Adela Golea, MD, PhD         
Spain
Country: Spain Recruiting
Santander, Spain
Contact: Luis Garcia-Castrillo, MD         
Principal Investigator: Luis Garcia-Castrillo, MD         
Turkey
Country: Turkey Recruiting
Ankara, Turkey
Contact: Mehmet Akif Karamercan, MD         
Principal Investigator: Mehmet Akif Karamercan, MD         
United Kingdom
Country: United Kingdom Not yet recruiting
Manchester, United Kingdom
Contact: Richard Body, MD, PhD         
Principal Investigator: Richard Body, MD, PhD         
Sponsors and Collaborators
Hopital Lariboisière
European Society for Emergency Medicine
Investigators
Principal Investigator: Said LARIBI, MD, PhD Lariboisière Hospital, EuSEM
  More Information

No publications provided

Responsible Party: Said LARIBI, MD, PhD., Principal Investigator, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02060799     History of Changes
Other Study ID Numbers: HLariboisiere
Study First Received: February 9, 2014
Last Updated: February 15, 2014
Health Authority: Belgium: Ethics Committee
Finland: National Advisory Board on Health Care Ethics
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Romania: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Turkey: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Hopital Lariboisière:
Dyspnea
Emergency Service, Hospital
prognosis
Fatal Outcome
Epidemiology

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

ClinicalTrials.gov processed this record on October 19, 2014