Registry of Patients With Acute Dyspnea in the Emergency Department

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Klinikum Nürnberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Michael Christ, Klinikum Nürnberg
ClinicalTrials.gov Identifier:
NCT01910233
First received: July 25, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  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


Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910233

Contacts
Contact: Michael Christ, Prof. +49 911 398 2369 michael.christ@klinikum-nuernberg.de
Contact: Felicitas Geier, M. Sc. +49 911 398 5561 felicitas.geier@klinikum-nuernberg.de

Locations
Germany
Department of Emergency and Critical Care Medicine, City Hospital Nuremberg Recruiting
Nuremberg, Bavaria, Germany, 90471
Contact: Michael Christ, Prof.    +49 911 398 2369    michael.christ@klinikum-nuernberg.de   
Principal Investigator: Michael Christ, Prof.         
Sponsors and Collaborators
Klinikum Nürnberg
Investigators
Principal Investigator: Michael Christ, Prof. Klinikum Nürnberg
  More Information

No publications provided

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: July 25, 2013
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
Heart Failure
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 23, 2014