Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department

NCT02122640 | Completed

• 1 other identifier: ECO/TOR
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT Introduction This is a prospective randomized trial realized in the Emergency Department of the University Hospital of Siena, Italy. Dyspnea is one of the most common causes worldwide of admission to the Emergency Department (ED) and acute heart failure (AHF) is a major cause of serious morbidity and death in such population, above all in elderly patients. Incidence rate is significantly higher in men than in women, in Europe it increases with age from 1.4/1000 person-years in subjects aged 55-59 years to 47.4/1000 person-years in those aged 90 years or older. The age-adjusted prevalence of AHF in the United States averages 36 cases per 100,000 of the population and accounts for 10,000 deaths annually. In clinical practice this symptomatology is usually investigated in the pre-hospital phase only with history and physical examination; in the ED blood gas analysis (BGA), laboratory tests and chest X-rays can be performed as primary exams. BNP and NT pro-BNP are now considered reliable biochemical markers to distinguish cardiogenic from pulmonary etiology, both for their diagnostic and prognostic value. On the other hand, these biomarkers are affected by a "grey zone" of uncertainty, they are not available in all hospitals and their dosage samples are expensive: thus we propose other tools to support the diagnostic process.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• Diagnostic Outcome (Reference Standard)

  Since a uniform reference test is lacking for acute heart failure, we chose to use a consensus diagnosis as formal reference standard, in analogy with earlier studies and as recommended by recent diagnostic research guidelines. An independent panel of experts (made up of two cardiologists and one senior emergency physician) judged all the collected data for each patient to determine the final diagnosis. The panel of experts assessed acute heart failure diagnosis following the criteria and approach outlined by the ESC Heart Failure Guidelines.

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients admitted to our Emergency Department from January 2011 to February 2013 with acute non-traumatic dyspnea. We included patients carried by ambulance and patients who came autonomously.

You may qualify if:

• All the patients admitted to our Emergency Department from January 2011 to February 2013 with acute non-traumatic dyspnea. We included patients carried by ambulance and patients who came autonomously.

You may not qualify if:

• Age \<18 years
• Post-traumatic dyspnea

Sponsors & Collaborators

• Comitato Etico di Area Vasta Sud Est: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, Siena, 53100, Italy

Location

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pastorelli

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 24, 2014
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

IT (1)