NCT01235182

Brief Summary

Acute heart failure is one of the main causes of acute respiratory distres in prehospital emergency setting. The early and correct diagnosis is important because the misdiagnosis can result in deleterious consequeance to patients. Rapid bedside tests (like NT-proBNP) and point-of-care lung ultrasound could be useful methods in field. This study confirmed that the combination of ultrasound sign in combination with rapid NT-proBNP test has a hibh diagnostic accuracy in differentiating between cardiac and pulmonray causes of acute dyspnea in the field and the tretament possibilities in clinical obscure cases are mainly improved.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
Last Updated

November 5, 2010

Status Verified

July 1, 2007

Enrollment Period

2.8 years

First QC Date

November 4, 2010

Last Update Submit

November 4, 2010

Conditions

Keywords

acute dyspneaprehospital emergency settingdifferential diagnosisultrasoundNT-proBNP

Study Arms (1)

acute dyspnea, field, diagnostic

All patients with shortness of breath as the primary complaint (defined as eitherthe sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea and were age \>18 years.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with acute dyspnea in the time o the investigation in the field-prehospital settingInclusion criterion for the study was 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 were 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, and gastroesophageal reflux disorder, according to the history, clinical status, and additional laboratory tests available in prehospital setting (D-dimer, troponin, C-reactive protein)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Emergency Medicine maribor

Maribor, 2000, Slovenia

Location

Related Publications (2)

  • Klemen P, Golub M, Grmec S. Combination of quantitative capnometry, N-terminal pro-brain natriuretic peptide, and clinical assessment in differentiating acute heart failure from pulmonary disease as cause of acute dyspnea in pre-hospital emergency setting: study of diagnostic accuracy. Croat Med J. 2009 Apr;50(2):133-42. doi: 10.3325/cmj.2009.50.133.

    PMID: 19399946BACKGROUND
  • Prosen G, Klemen P, Strnad M, Grmec S. Combination of lung ultrasound (a comet-tail sign) and N-terminal pro-brain natriuretic peptide in differentiating acute heart failure from chronic obstructive pulmonary disease and asthma as cause of acute dyspnea in prehospital emergency setting. Crit Care. 2011;15(2):R114. doi: 10.1186/cc10140. Epub 2011 Apr 14.

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Štefek Grmec, MD,PhD,Prof.

    Center of Health Center for Emergency Medicine Maribor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

July 1, 2007

Primary Completion

April 1, 2010

Study Completion

August 1, 2010

Last Updated

November 5, 2010

Record last verified: 2007-07

Locations