Dyspnea and Biomarkers in a Prehospital Setting

This study has been completed.
Sponsor:
Information provided by:
Health Care Center Maribor
ClinicalTrials.gov Identifier:
NCT00878475
First received: April 8, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition
Dyspnea
Heart Failure
Asthma
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Capnometry and Nt-proBNP in Differentiating of Acute Dyspnea in Pre-Hospital Emergency Setting

Resource links provided by NLM:


Further study details as provided by Health Care Center Maribor:

Enrollment: 546
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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)
  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: NCT00878475

Locations
Slovenia
Health Center Maribor, Center for Emergency Medicine
Maribor, Slovenia, 2000
Sponsors and Collaborators
Health Care Center Maribor
Investigators
Principal Investigator: Štefek Grmec, Prof,MD,PhD Health Center, Center for emergency Medicine Maribor
  More Information

No publications provided by Health Care Center Maribor

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof.Štefek Grmec, MD, PhD, Health Center Maribor, Emergency Medicine center
ClinicalTrials.gov Identifier: NCT00878475     History of Changes
Other Study ID Numbers: grmec62
Study First Received: April 8, 2009
Last Updated: April 8, 2009
Health Authority: Slovenia: Ministry of Health

Keywords provided by Health Care Center Maribor:
Quantitative Capnometry
N-Terminal Pro-Brain Natriuretic Peptide
Acute Heart Failure
Diagnostic Accuracy

Additional relevant MeSH terms:
Asthma
Dyspnea
Heart Failure
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014