Registry of Patients With Acute Dyspnea in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT01910233
First received: July 25, 2013
Last updated: March 31, 2016
Last verified: March 2016
  Purpose
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
Dyspnea
Heart Failure
COPD

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Klinikum Nürnberg:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • demographics and baseline characteristics [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    baseline characteristics as for example vital signs, medication, underlying disease condition (adjusted final diagnosis), medical history, concomitant diseases

  • medical care processes [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    type of referral, disposition patterns, diagnostic and therapeutical measures

  • subjective and objective risk assessment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    data from the questionnaire completed by triage nurse and attending physician, OPTIMIZE-HF and PRIDE mortality score


Enrollment: 947
Study Start Date: May 2013
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
adult patients with acute dyspnea in ED

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to the emergency department of the city hospital Nuremberg
Criteria

Inclusion Criteria:

  • expression of acute dyspnea in the emergency department

Exclusion Criteria:

  • age < 18 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01910233

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

Responsible Party: Prof. Dr. Michael Christ, Prof. Dr. med. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier: NCT01910233     History of Changes
Other Study ID Numbers: OOB01 
Study First Received: July 25, 2013
Last Updated: March 31, 2016
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Nürnberg:
dyspnea
registry
baseline characteristics
mortality
risk assessment
emergency department

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

ClinicalTrials.gov processed this record on May 24, 2016