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DyspneaEuroDEMNCT02060799

European Dyspnoea Survey in the EMergency Departments

An observational study of Dyspnea and Emergencies, run by Hopital Lariboisière at 10 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea, Emergencies
How many people
2,156 participants
Where
10 sitesin 10 countries
Study dates
Feb 2014to Nov 2014
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • No acceptance to participate from the patient

Trial locations and contacts

10 sites in 10 countries.

10 sites in 10 countries

Belgium1 site
  • Country: Belgium

    Brussels

Other trials in Belgium

Finland1 site
  • Country: Finland

    Helsinki

Other trials in Finland

France1 site
  • Country: France

    Paris

Other trials in France

Germany1 site
  • Country: Germany

    Nuremberg

Other trials in Germany

Italy1 site
  • Country: Italy

    Rome

Other trials in Italy

Netherlands1 site
  • Country: Netherlands

    Amsterdam

Other trials in Netherlands

Romania1 site
  • Country: Romania

    Cluj-Napoca

Other trials in Romania

Spain1 site
  • Country: Spain

    Santander

Other trials in Spain

Turkey (Türkiye)1 site
  • Country: Turkey

    Ankara

Other trials in Turkey (Türkiye)

United Kingdom1 site
  • Country: United Kingdom

    Manchester

Other trials in United Kingdom

About this study

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.

Read more

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.

Read the 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.
Conditions
Dyspnea, Emergencies
Keywords
Dyspnea, Emergency Service, Hospital, prognosis, Fatal Outcome, Epidemiology
Medical subject headings
Dyspnea, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    All cause mortality will be evaluated 30 days after ED visit.

    Measured: 30 days

Secondary outcomes (1)
  1. All cause rehospitalization

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionMar 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,156 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060799
Sponsor's protocol ID
HLariboisiere
Acronym
EuroDEM
Status last verified
Dec 2014
First submitted
9 Feb 2014
Last updated
18 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Dyspnea and Emergencies, run by Hopital Lariboisière at 10 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Belgium, Finland, France, Germany, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.

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