- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060799
European Dyspnoea Survey in the EMergency Departments (EuroDEM)
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
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
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Said LARIBI, MD, PhD, Lariboisière Hospital, EuSEM
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLariboisiere
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.
Clinical Trials on Emergencies
-
Central Hospital, Nancy, FranceCompleted
-
Universidad de AntioquiaCompleted
-
Second Affiliated Hospital, School of Medicine,...UnknownMedical EmergenciesChina
-
Betsi Cadwaladr University Health BoardRecruitingMedical EmergenciesUnited Kingdom
-
Technische Universität DresdenCompletedPerformance in Simulated Emergencies | Stress During Simulator Scenario | Behaviour of Physicians in Simulated EmergenciesGermany
-
Charite University, Berlin, GermanyZentralinstitut für die Kassenärztliche Versorgung in DeutschlandUnknownNon-urgent EmergenciesGermany
-
Peking University People's HospitalBeijing Emergency Medical Center; Beijing Red Cross Emergency CenterCompletedEmergencies [Disease/Finding]China
-
M.D. Anderson Cancer CenterRecruitingOncologic Complications and EmergenciesUnited States
-
Copenhagen Academy for Medical Education and SimulationCompletedCardiopulmonary Resuscitation | Education | Medical Emergencies
-
Chinese University of Hong KongUnknownEmergencies | Cancer | Oncologic Complications and EmergenciesChina