Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea
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|ClinicalTrials.gov Identifier: NCT02105207|
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dyspnea Congestive Heart Failure||Other: Lung Ultrasound Other: Chest Radiography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||530 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||February 2016|
Experimental: Lung Ultrasound
In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography.
Other: Lung Ultrasound
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Experimental: Chest Radiography
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
Chest Radiography is performed after clinical evaluation without using ultrasound assessment
- Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients [ Time Frame: Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours. ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105207
|Emergency Department Azienda Ospedaliera Universitaria Careggi|
|Firenze, Tuscany, Italy, 50134|
|AOU Città della Salute e della Scienza di Torino|
|Turin, Italy, 10126|
|Principal Investigator:||Enrico Lupia, MD, PhD||University of Turin, Italy|