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.
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
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.
All cause mortality
All cause mortality will be evaluated 30 days after ED visit.
Measured: 30 days
Secondary outcomes (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.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Said LARIBI, MD, PhD., Hopital Lariboisière
- Investigators
- Said LARIBI, MD, PhD, Principal investigator, Lariboisière Hospital, EuSEM
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Dyspnoea Survey in the EMergency Departments
- ClinicalTrials.gov ID
- NCT02060799
- Acronym / sponsor ID
- EuroDEM / HLariboisiere
- Conditions
- Dyspnea, Emergencies
- Keywords
- Dyspnea, Emergency Service, Hospital, prognosis, Fatal Outcome, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,156 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint during the study period.
Key inclusion criteria (2 listed)
- Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint
- 18 years or older
Key exclusion criteria (1 listed)
- No acceptance to participate from the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: 30 days
All cause mortality will be evaluated 30 days after ED visit.
1 secondary outcome
All cause rehospitalization
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said LARIBI, MD, PhD principal investigator
Lariboisière Hospital, EuSEM
10 sites in 10 countries: see every site and its status.
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.