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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00833144
Other study ID # IRB00015895
Secondary ID 2008125
Status Completed
Phase N/A
First received January 29, 2009
Last updated December 12, 2013
Start date February 2009
Est. completion date February 2011

Study information

Verified date December 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Patients often arrive to the Emergency Department with the chief complaint of shortness of breath. The cause of the shortness of breath may be due to many things, such as pneumonia, emphysema, a heart attack, heart failure, and others. It is often very difficult for the physician to determine the cause of the shortness of breath in the first two hours in the Emergency Department. This ambiguity makes treating the patient very difficult. Although a patient could benefit from treatment upon arrival, the emergent treatment of the condition must wait until a final diagnosis is made.

Recently, emergency physicians have been using portable ultrasound at the patient's bedside to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent research suggests that heart failure, one of the causes of shortness of breath, may be diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the intensive care and cardiology. However, no research has yet been performed to determine if emergency physicians can effectively use ultrasound to quickly diagnose and treat heart failure within the first few minutes of a patient's arrival to the emergency department. The hypothesis of this study is to evaluate the ability of residents in emergency medicine to use ultrasound to diagnose patients in heart failure who presented with the chief complaint of shortness of breath. The final diagnosis of the patient upon discharge from the hospital will be compared to the preliminary diagnosis based on the portable ultrasound findings.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date February 2011
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age > 18

- presenting complaint of shortness of breath or dyspnea

Exclusion Criteria:

- prisoners

- pregnant women

- shortness of breath clearly secondary to another diagnosis (i.e. trauma)

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Grady Memorial Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. — View Citation

Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. — View Citation

Lichtenstein D, Mezière G. A lung ultrasound sign allowing bedside distinction between pulmonary edema and COPD: the comet-tail artifact. Intensive Care Med. 1998 Dec;24(12):1331-4. — 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

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity and specificity of the ultrasound lung rockets to predict congestive heart failure One year No
Secondary comparison of the BNP with the thoracic ultrasound findings One year No
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