Lung Ultrasound for Acute Dyspnea in Emergency Department

Congestive Heart Failure Clinical Trial

Official title:

Lung Ultrasound for Acute Dyspnea in Emergency Department - Prospective Multicenter Study on Accuracy, Reproducibility, and Diagnostic Impact of Lung Ultrasound in the Evaluation of Patients With Dyspnea in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287429
• Other study ID #: CEU-UTurin-001
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: November 19, 2012
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2010
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Dyspnea is a frequent symptom in patients admitted to the Emergency Department (ED); discriminating between cardiogenic and non-cardiogenic dyspnea is a common clinical dilemma. The initial diagnostic work-out is often not very accurate in defining the etiology and the underlying pathophysiology. In the last years, lung ultrasound (US) has emerged as a useful real-time bedside diagnostic tool in the critical patient. The aim of this study was to evaluate the accuracy, reproducibility, and diagnostic impact of pleural and lung US, performed by emergency physicians at the time of patient first presentation to the ED, in identifying cardiac causes of acute dyspnea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1005
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients had to present to the ED with a principal complaint of shortness of breath, de?ned as either the sudden onset of dyspnea with no history of chronic dyspnea or an increase in the severity of chronic dyspnea in the last 48 hours;

• Presence of an emergency physician with lung US experience at the time of enrollment;

• US examination within 30 minutes after the start of the clinical evaluation.

Exclusion Criteria:

• Dyspnea cases clearly due to neither cardiogenic nor respiratory etiology will considered not eligible.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Dyspnea
• Heart Failure

Intervention

Other:
• lung and pleural ultrasound
After the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient.

Locations

Country	Name	City	State
Italy	Emergency Medicine & Surgery Unit - Cardinal Massaia Hospital	Asti
Italy	Emergency Department - AO Santa Croce e Carle	Cuneo
Italy	Emergency Medicine Unit - AOU San Luigi Gonzaga	Orbassano
Italy	Emergency Medicine & Surgery Unit - Pinerolo General Hospital, ASL TO 3	Pinerolo
Italy	Emergency Department - AOU San Giovanni Battista	Turin
Italy	Emergency Medicine & Surgery Unit - Martini Hospital, ASL TO 2	Turin
Italy	Emergency Medicine and Surgery Unit- AO Mauriziano	Turin

Sponsors (8)

Lead Sponsor	Collaborator
University of Turin, Italy	Agnelli Hospital, Italy, Azienda Ospedaliera Ordine Mauriziano di Torino, Azienda Ospedaliera San Giovanni Battista, Martini Hospital, Turin, Italy, Ospedale Cardinal Massaia, Ospedale Santa Croce-Carle Cuneo, San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (24)

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Cardinale L, Volpicelli G, Binello F, Garofalo G, Priola SM, Veltri A, Fava C. Clinical application of lung ultrasound in patients with acute dyspnea: differential diagnosis between cardiogenic and pulmonary causes. Radiol Med. 2009 Oct;114(7):1053-64. doi: 10.1007/s11547-009-0451-1. Epub 2009 Aug 20. Review. — View Citation

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Lichtenstein DA. Ultrasound in the management of thoracic disease. Crit Care Med. 2007 May;35(5 Suppl):S250-61. Review. — View Citation

Liteplo AS, Marill KA, Villen T, Miller RM, Murray AF, Croft PE, Capp R, Noble VE. Emergency thoracic ultrasound in the differentiation of the etiology of shortness of breath (ETUDES): sonographic B-lines and N-terminal pro-brain-type natriuretic peptide in diagnosing congestive heart failure. Acad Emerg Med. 2009 Mar;16(3):201-10. doi: 10.1111/j.1553-2712.2008.00347.x. Epub 2009 Jan 29. — View Citation

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. — View Citation

Picano E, Frassi F, Agricola E, Gligorova S, Gargani L, Mottola G. Ultrasound lung comets: a clinically useful sign of extravascular lung water. J Am Soc Echocardiogr. 2006 Mar;19(3):356-63. Review. — View Citation

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Volpicelli G, Cardinale L, Garofalo G, Veltri A. Usefulness of lung ultrasound in the bedside distinction between pulmonary edema and exacerbation of COPD. Emerg Radiol. 2008 May;15(3):145-51. doi: 10.1007/s10140-008-0701-x. Epub 2008 Jan 31. Review. — View Citation

Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. — View Citation

Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. Review. — View Citation

* Note: There are 24 references in all — Click here to view all references