Acute Heart FailureECO/TORNCT02122640
Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department
An observational study of Acute Heart Failure, run by Comitato Etico di Area Vasta Sud Est at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age <18 years
- Post-traumatic dyspnea
Trial locations and contacts
1 site in 1 country.
About this study
LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT
Introduction
Read more
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.
Read the detailed description
THE RATIONALE OF THE STUDY
It is widely reported in literature that ultrasound can identify the presence of interstitial and pulmonary alveolar syndrome by comet tail artifact with good sensitivity and specificity. This is an easy technique to perform and interpret, readily available and repeatable over time and executable bedside even in emergency situations. The execution of this investigative technique in the ED and also in a pre-hospital setting would provide additional and reliable information for patients with dyspnea, so favoring rapid identification of the etiology.
Accepting these observations, lung ultrasound (LUS) could have a central role in the evaluation of patients with shortness of breath in ED. Even the LUS in many studies has been considered useful for detecting pulmonary alterations, there are few data regarding its utilization in clinical practice and there is a lack of evidences concerning validated operative protocols. On this basis, it was decided to evaluate the employment of LUS in the ED with a structured and practical protocol.
ETHICAL ASPECTS
This study will be conducted according to Helsinki Declaration and i twill be approved by our Local Ethics Committee.
AIMS OF THE STUDY
The main aim of this study was to analyze if lung ultrasound (LUS) could be a useful tool for the early identification of heart failure in patients presenting to ED for dyspnea.
The secondary objective was to identify a protocol model for the management of acute dyspnea on the basis of lung ultrasound pattern when added to other validated diagnostic tools.
INCLUSIONS CRITERIA
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.
EXCLUSIONS CRITERIA
Age <18 years
Post-traumatic dyspnea
METHODS
After triage, standardized diagnostic work-up included: 1) brief patient history (age, gender, symptoms, medical history); 2) Vital Parameters (Blood Pressure, Heart Rate, Arterial Oxygen Saturation, Respiratory Rate, Body Temperature); 3) 12 lead EKG; 4) Standard laboratory assessment (NT-proBNP - ECLIA, Roche Methodics®, Creatinine, BUN, C-Reactive Protein, Full Blood Count, Electrolytes); 5) Blood Gas Analysis. Data were collected and stored in a database.
An independent operator performed LUS right after the admission (unaware of patient history and vitals), then the attending physician acquired full medical history, Physical Examination (according to Boston Criteria for Heart Failure) and requested Chest X-Ray. Echocardiography was performed in order to validate heart failure diagnosis even if it was not considered in our protocol because not available 24h/day in our Emergency Department. All LUS operators were emergency physicians trained in LUS.
Lung Ultrasound We used Esaote MyLab30™ and MyLab70™ Ultrasound with Variable-Band Convex Array (3,5-5 MHz). Six transversal scans for each hemithorax (second and fourth intercostal space on the hemiclavear line, anterior axillar line, middle axillar line, see Figure 1). Basal scans of the lung were sampled in order to identify pleural effusions.
We chose this anterior approach for the difficulties related to a complete evaluation of the chest in case of severe dyspnea and non-collaborative patients.
B-lines are defined as vertical, hyperechogenic, reverberation artifacts that arise from the pleural line to the bottom of the screen and moving synchronously with lung sliding; a positive region is defined by the presence of three or more B-lines in a longitudinal plane between two ribs. Acute interstitial pulmonary syndrome was defined, according to the International Consensus Conference on LUS, as the presence of two or more positive regions in each hemithorax.
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.
LENGHT OF THE STUDY
From January 2011 to February 2013
DATA COLLECTION
Data collection form included:
Personal data Medical hystory VItals signs; ECG; BGA; Medical Examination; Standard Blood Test plus NT pro-BNP; Chest X-ray; Echocardiography; Lung Ultrasound
STATISTICAL ANALYSIS
Edited to Prof. Cevenini.
- Conditions
- Acute Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Comitato Etico di Area Vasta Sud Est
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcellopastorelli, Comitato Etico di Area Vasta Sud Est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122640
- Sponsor's protocol ID
- ECO/TOR
- Acronym
- ECO/TOR
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department
- ClinicalTrials.gov ID
- NCT02122640
- Acronym / sponsor ID
- ECO/TOR / ECO/TOR
- Conditions
- Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Comitato Etico di Area Vasta Sud EstUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
THE RATIONALE OF THE STUDY
It is widely reported in literature that ultrasound can identify the presence of interstitial and pulmonary alveolar syndrome by comet tail artifact with good sensitivity and specificity. This is an easy technique to perform and interpret, readily available and repeatable over time and executable bedside even in emergency situations. The execution of this investigative technique in the ED and also in a pre-hospital setting would provide additional and reliable information for patients with dyspnea, so favoring rapid identification of the etiology.
Accepting these observations, lung ultrasound (LUS) could have a central role in the evaluation of patients with shortness of breath in ED. Even the LUS in many studies has been considered useful for detecting pulmonary alterations, there are few data regarding its utilization in clinical practice and there is a lack of evidences concerning validated operative protocols. On this basis, it was decided to evaluate the employment of LUS in the ED with a structured and practical protocol.
ETHICAL ASPECTS
This study will be conducted according to Helsinki Declaration and i twill be approved by our Local Ethics Committee.
AIMS OF THE STUDY
The main aim of this study was to analyze if lung ultrasound (LUS) could be a useful tool for the early identification of heart failure in patients presenting to ED for dyspnea.
The secondary objective was to identify a protocol model for the management of acute dyspnea on the basis of lung ultrasound pattern when added to other validated diagnostic tools.
INCLUSIONS CRITERIA
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.
EXCLUSIONS CRITERIA
Age <18 years
Post-traumatic dyspnea
METHODS
After triage, standardized diagnostic work-up included: 1) brief patient history (age, gender, symptoms, medical history); 2) Vital Parameters (Blood Pressure, Heart Rate, Arterial Oxygen Saturation, Respiratory Rate, Body Temperature); 3) 12 lead EKG; 4) Standard laboratory assessment (NT-proBNP - ECLIA, Roche Methodics®, Creatinine, BUN, C-Reactive Protein, Full Blood Count, Electrolytes); 5) Blood Gas Analysis. Data were collected and stored in a database.
An independent operator performed LUS right after the admission (unaware of patient history and vitals), then the attending physician acquired full medical history, Physical Examination (according to Boston Criteria for Heart Failure) and requested Chest X-Ray. Echocardiography was performed in order to validate heart failure diagnosis even if it was not considered in our protocol because not available 24h/day in our Emergency Department. All LUS operators were emergency physicians trained in LUS.
Lung Ultrasound We used Esaote MyLab30™ and MyLab70™ Ultrasound with Variable-Band Convex Array (3,5-5 MHz). Six transversal scans for each hemithorax (second and fourth intercostal space on the hemiclavear line, anterior axillar line, middle axillar line, see Figure 1). Basal scans of the lung were sampled in order to identify pleural effusions.
We chose this anterior approach for the difficulties related to a complete evaluation of the chest in case of severe dyspnea and non-collaborative patients.
B-lines are defined as vertical, hyperechogenic, reverberation artifacts that arise from the pleural line to the bottom of the screen and moving synchronously with lung sliding; a positive region is defined by the presence of three or more B-lines in a longitudinal plane between two ribs. Acute interstitial pulmonary syndrome was defined, according to the International Consensus Conference on LUS, as the presence of two or more positive regions in each hemithorax.
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.
LENGHT OF THE STUDY
From January 2011 to February 2013
DATA COLLECTION
Data collection form included:
Personal data Medical hystory VItals signs; ECG; BGA; Medical Examination; Standard Blood Test plus NT pro-BNP; Chest X-ray; Echocardiography; Lung Ultrasound
STATISTICAL ANALYSIS
Edited to Prof. Cevenini.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Age <18 years
- Post-traumatic dyspnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Outcome (Reference Standard)
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Comitato Etico di Area Vasta Sud Est at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Outcome (Reference Standard) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.