Registry of Patients With Acute Dyspnea in the Emergency Department

Heart Failure Clinical Trial

Official title:

Prospective Registry for Quality Assurance of Medical Care of Patients With Acute Dyspnea in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910233
• Other study ID #: OOB01
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: March 31, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Klinikum Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• expression of acute dyspnea in the emergency department

Exclusion Criteria:

• age < 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Emergencies
• Heart Failure

Locations

Country	Name	City	State
Germany	Department of Emergency and Critical Care Medicine, City Hospital Nuremberg	Nuremberg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		6 months	No
Secondary	demographics and baseline characteristics	baseline characteristics as for example vital signs, medication, underlying disease condition (adjusted final diagnosis), medical history, concomitant diseases	1 month	No
Secondary	medical care processes	type of referral, disposition patterns, diagnostic and therapeutical measures	1 day	No
Secondary	subjective and objective risk assessment	data from the questionnaire completed by triage nurse and attending physician, OPTIMIZE-HF and PRIDE mortality score	1 month	No