Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea

Study Overview
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Brief Summary
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For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.

Detailed Description
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Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea. Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology (LUS-implemented diagnosis). All patients will then undergo CXR. In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available. After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case. Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. Positive and negative results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.

Official Title
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Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department

Conditions
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Dyspnea, Congestive Heart Failure

Intervention / Treatment
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* Other: Lung Ultrasound
* Other: Chest Radiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute dyspnea as chief complaint presence of an emergency physician skilled in lung ultrasound at evaluation time Exclusion Criteria: mechanical ventilation ongoing at enrolment time dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Ultrasound<br>In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography. | Other: Lung Ultrasound<br>* Lung ultrasound evaluation is performed after clinical assessment and before chest radiography<br>|
| Experimental: Chest Radiography<br>In Patients allocated to this arm chest radiography will be performed for the detection of indirect signs of pulmonary congestion/ADHF without ultrasound evaluation. | Other: Chest Radiography<br>* Chest Radiography is performed after clinical evaluation without using ultrasound assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients | Accuracy of lung ultrasound and chest radiography will be measured using as gold standard the independent evaluation of the entire medical records by two expert emergency physicians blinded to the lung ultrasound results and radiographic reports (digitalized chest radiography images will be available). | Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours. |