Dyspnea and Biomarkers in a Prehospital Setting

Completed

• Conditions: Asthma; Dyspnea; Heart Failure; COPD

• Registration Number: NCT00878475
• Lead Sponsor: Community Healthcare Center dr. Adolf Drolc Maribor (HCM)

Brief Summary

In patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. Physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (HF) from pulmonary causes of dyspnea. Timely differentiation of HF from other causes of dyspnea may permit the early institution of appropriate medical therapy. Brain natriuretic peptide (BNP) and amino-terminal pro-brain natriuretic peptide (NT-proBNP) have been proposed as early markers of HF and demonstrated to be useful for diagnosing and excluding HF in the emergency department. A combination of BNP or NT-proBNP testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. Some previous studies have also suggested that quantitative capnometry (QC) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. Therefore, the investigators hypothesized that a new combination of NT-proBNP testing, standard clinical assessment, and partial pressure of end-tidal CO2 (PetCO2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting.

The aim of this study was to determine the accuracy of combination of QC, NT-proBNP, and clinical assessment in differentiating acute HF from obstructive pulmonary disease (COPD/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-04
• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Last Update Submitted: 2009-04-08
• Study First Posted: 2009-04-09
• Last Update Posted: 2009-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

• patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea)

Exclusion Criteria

• age <18 years

• history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea:

  • pneumonia
  • pulmonary embolism
  • carcinoma
  • pneumothorax
  • pleural effusion
  • intoxications (drugs)
  • anaphylactic reactions
  • upper airway obstruction
  • bronchial stenosis
  • gastroesophageal reflux disorder

• according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (D-dimer, troponin, C-reactive protein)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Health Center Maribor, Center for Emergency Medicine; 🇸🇮 Maribor, Slovenia