NCT00833144

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

January 29, 2009

Last Update Submit

December 12, 2013

Conditions

Keywords

heart failuredyspneaultrasound

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity of the ultrasound lung rockets to predict congestive heart failure

    One year

Secondary Outcomes (1)

  • comparison of the BNP with the thoracic ultrasound findings

    One year

Study Arms (2)

1

Congestive Heart Failure

2

Patients without congestive heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the Emergency Care Center with the chief complaint of shortness of breath or dyspnea will be eligible for the study.

You may qualify if:

  • age \> 18
  • presenting complaint of shortness of breath or dyspnea

You may not qualify if:

  • prisoners
  • pregnant women
  • shortness of breath clearly secondary to another diagnosis (i.e. trauma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Related 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. doi: 10.1378/chest.127.5.1690.

    PMID: 15888847BACKGROUND
  • 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. doi: 10.1016/j.amjcard.2004.02.012.

    PMID: 15135701BACKGROUND
  • Lichtenstein D, Meziere 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. doi: 10.1007/s001340050771.

    PMID: 9885889BACKGROUND
  • 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.

    PMID: 12124404BACKGROUND

MeSH Terms

Conditions

Heart FailureDyspnea

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Manson, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2011

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations