Registry of Patients With Acute Dyspnea in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01910233
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg

Brief Summary:
This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg. There is evidence that acute dyspnea is associated with a mortality rate of 10%, however acute dyspnea is not perceived as a life-threatening condition, both in public and in health care providers. Our aim is to describe the patient collective concerning their demographics, baseline characteristics, type of referral and disposition, medical care processes and prognosis. Secondly, we want to evaluate if the subjective risk assessment of emergency department personnel matches with objective risk stratification tools and the actual outcome of the studied patients.

Condition or disease
Dyspnea Heart Failure COPD

Detailed Description:
This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg during May 23th 2013 and October 31th 2013. To be included into the registry the patient has to express acute dyspnea. Minor patients are not included. The admission documents of the studied patients are accompanied by a questionnaire that has to be completed by the triage nurse and the attending physician. The questionnaire includes items like professional experience and subjective assessment of patient's prognosis. In addition the attending physician has to state if the evaluation of medical history was difficult, if previous medication is known and how likely the presence of heart failure as underlying condition is. Data of the questionnaire, the patient record and the follow up contacts are entered in a SPSS database. Finally, we measure the OPTIMIZE-HF score (Abraham et al. 2008) and the PRIDE mortality score (Baggish et al. 2007) in a retrospective manner in order to compare the subjective assessments with objective criteria.

Study Type : Observational [Patient Registry]
Actual Enrollment : 947 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prospective Registry for Quality Assurance of Medical Care of Patients With Acute Dyspnea in the Emergency Department
Study Start Date : May 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

adult patients with acute dyspnea in ED

Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. demographics and baseline characteristics [ Time Frame: 1 month ]
    baseline characteristics as for example vital signs, medication, underlying disease condition (adjusted final diagnosis), medical history, concomitant diseases

  2. medical care processes [ Time Frame: 1 day ]
    type of referral, disposition patterns, diagnostic and therapeutical measures

  3. subjective and objective risk assessment [ Time Frame: 1 month ]
    data from the questionnaire completed by triage nurse and attending physician, OPTIMIZE-HF and PRIDE mortality score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the emergency department of the city hospital Nuremberg

Inclusion Criteria:

  • expression of acute dyspnea in the emergency department

Exclusion Criteria:

  • age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01910233

Department of Emergency and Critical Care Medicine, City Hospital Nuremberg
Nuremberg, Bavaria, Germany, 90471
Sponsors and Collaborators
Klinikum Nürnberg
Principal Investigator: Michael Christ, Prof. Klinikum Nürnberg

Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg Identifier: NCT01910233     History of Changes
Other Study ID Numbers: OOB01
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by Prof. Dr. Michael Christ, Klinikum Nürnberg:
baseline characteristics
risk assessment
emergency department

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms