Dyspnea and Biomarkers in a Prehospital Setting

April 8, 2009 updated by: Health Care Center Maribor

Quantitative Capnometry and Nt-proBNP in Differentiating of Acute Dyspnea in Pre-Hospital Emergency Setting

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

546

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maribor, Slovenia, 2000
        • Health Center Maribor, Center for Emergency Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

During the period of the study, 546 consecutive patients with acute dyspnea were treated by emergency teams (emergency physician, register nurse, and medical technician/driver in an ambulance-car or at pre-hospital emergency medical center). After pre-hospital care, all patients were admitted to the University Clinical Center Maribor and followed until discharge.

To be eligible for the study, a 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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group with obstructive causes of dyspnea
Criteria for clinical assessment of severe asthma (diffuse polyphonic bilateral and particular expiratory wheezes, chest tightness, shortness of breath, using accessory muscles of breathing, signs of hyperinflation, atopic condition, personal or family history of asthma, tachypnea, previous asthma and asthma medications, and the value of modified Boston criteria for HF ≤ 5) and criteria for chronic obstructive pulmonary disease (COPD) exacerbation (history of COPD, COPD medications, cough, worsening dyspnea, increased sputum production and volume, increased sputum purulence, rhonchi and rales, modified Boston criteria for HF ≤ 5)
Heart failure group
The investigators protocol for clinical assessment of HF-related acute dyspnea (the prehospital clinical assessment for HF) was designed based on Boston (13) and Framingham criteria for HF (14) (Table 1). The investigators did not use certain criteria from the original protocols, which were not available in the prehospital setting (e.g., chest radiography).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Štefek Grmec, Prof,MD,PhD, Health Center, Center for emergency Medicine Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Estimate)

April 9, 2009

Last Update Submitted That Met QC Criteria

April 8, 2009

Last Verified

April 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

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