Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea
Primary Purpose
Dyspnea, Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lung Ultrasound
Chest Radiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyspnea
Eligibility 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)
Sites / Locations
- Emergency Department Azienda Ospedaliera Universitaria Careggi
- AOU Città della Salute e della Scienza di Torino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lung Ultrasound
Chest Radiography
Arm Description
In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02105207
First Posted
March 27, 2014
Last Updated
April 5, 2016
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02105207
Brief Title
Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea
Official Title
Comparison Between Lung Ultrasound and Chest Radiography for Differential Diagnosis of Acute Dyspnea in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Congestive Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung Ultrasound
Arm Type
Experimental
Arm Description
In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography.
Arm Title
Chest Radiography
Arm Type
Experimental
Arm Description
In Patients allocated to this arm chest radiography will be performed for the detection of indirect signs of pulmonary congestion/ADHF without ultrasound evaluation.
Intervention Type
Other
Intervention Name(s)
Lung Ultrasound
Intervention Description
Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
Intervention Type
Other
Intervention Name(s)
Chest Radiography
Intervention Description
Chest Radiography is performed after clinical evaluation without using ultrasound assessment
Primary Outcome Measure Information:
Title
Accuracy of Lung Ultrasound and Chest Radiography in dyspnoeic patients
Description
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).
Time Frame
Accuracy will be measured at the end of clinical evaluation in the Emergency Department, an expected average of 2 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Lupia, MD, PhD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department Azienda Ospedaliera Universitaria Careggi
City
Firenze
State/Province
Tuscany
ZIP/Postal Code
50134
Country
Italy
Facility Name
AOU Città della Salute e della Scienza di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
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Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea
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