Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea

NCT02105207 | Completed

• 1 other identifier: iLUS-RCT
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 2

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.

Conditions

Dyspnea; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Lung Ultrasound

EXPERIMENTAL

In Patients allocated to this arm Lung ultrasound for detection of interstitial syndrome will be performed before chest radiography.

Other: Lung Ultrasound

Chest Radiography

EXPERIMENTAL

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

Interventions

Lung Ultrasound OTHER

Lung ultrasound evaluation is performed after clinical assessment and before chest radiography

Lung Ultrasound

Chest Radiography OTHER

Chest Radiography is performed after clinical evaluation without using ultrasound assessment

Chest Radiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute dyspnea as chief complaint
• presence of an emergency physician skilled in lung ultrasound at evaluation time

You may not qualify if:

• mechanical ventilation ongoing at enrolment time
• dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (2)

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

AOU Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Location

Related Publications (28)

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• Cibinel GA, Casoli G, Elia F, Padoan M, Pivetta E, Lupia E, Goffi A. Diagnostic accuracy and reproducibility of pleural and lung ultrasound in discriminating cardiogenic causes of acute dyspnea in the emergency department. Intern Emerg Med. 2012 Feb;7(1):65-70. doi: 10.1007/s11739-011-0709-1. Epub 2011 Oct 28.

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• Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J, Nowak RM, Aumont MC, Duc P, Hollander JE, Wu AH, McCullough PA, Maisel AS. Diagnostic value of B-Type natriuretic peptide and chest radiographic findings in patients with acute dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. doi: 10.1016/j.amjmed.2003.10.028.

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• Gargani L, Frassi F, Soldati G, Tesorio P, Gheorghiade M, Picano E. Ultrasound lung comets for the differential diagnosis of acute cardiogenic dyspnoea: a comparison with natriuretic peptides. Eur J Heart Fail. 2008 Jan;10(1):70-7. doi: 10.1016/j.ejheart.2007.10.009.

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• Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.

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MeSH Terms

Conditions

Dyspnea; Heart Failure

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Enrico Lupia, MD, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 7, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

IT (2)