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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
Sponsor:
Information provided by (Responsible Party):
Enrico Lupia, MD, PhD, University of Turin, Italy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyspnea Congestive Heart Failure Other: Lung Ultrasound Other: Chest Radiography Not Applicable

Detailed Description:

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

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
Italy
Emergency Department Azienda Ospedaliera Universitaria Careggi
Firenze, Tuscany, Italy, 50134
AOU Città della Salute e della Scienza di Torino
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Enrico Lupia, MD, PhD University of Turin, Italy

Publications:

Responsible Party: Enrico Lupia, MD, PhD, Assistant Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02105207     History of Changes
Other Study ID Numbers: iLUS-RCT
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Heart Failure
Dyspnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms