Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope

NCT ID: NCT01671371

Last Updated: 2016-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-07-31

Brief Summary

The purpose of this study is to determine whether point-of-care (bedside) ultrasound assists physicians in the evaluation and management of patients with syncope.

Detailed Description

Syncope is one of the more common presentations to the Emergency Department, representing between 1.2-1.5% of all evaluated patients and up to 6% of admissions. Due to an often broad and overlapping differential diagnosis, syncope represents a disease entity that often requires extensive workup. This typically involves laboratory tests, EKGs, x-rays, computed tomography, or other studies that are costly, time-consuming, and, in the case of diagnostic imaging, frequently involves ionizing radiation. Yet, despite extensive testing, an exact diagnosis is not made in up to 50% of cases.

Cardiac causes of syncope include myocardial infarction, pericardial effusion, volume depletion, arrhythmia, among other entities, many of which are life threatening. Echocardiography (cardiac ultrasound) has been used for inpatient syncope evaluations for several decades. In the Emergency Department, echocardiography is currently being used at the point-of-care (POC) in a limited and focused approach to a variety of conditions. However, POC ultrasound has never been systematically evaluated as a diagnostic or prognostic tool specifically for syncope in the Emergency Department. We aim to determine if an ultrasound-based protocol is effective as an adjunct in the evaluation of syncope. Our research study will examine the utility of POC ultrasound in the diagnosis, imaging and laboratory utilization, and prognosis of syncope in the Emergency Department.

Conditions

Syncope

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Immediate Ultrasound

A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)

Group Type: OTHER

Point-of-Care Ultrasound

Intervention Type: OTHER

Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility

Delayed Ultrasound

A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization

Group Type: OTHER

Point-of-Care Ultrasound

Intervention Type: OTHER

Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility

Interventions

Point-of-Care Ultrasound

Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years and older presenting to the ED with acute syncope (defined as transient loss of consciousness) or near syncope (sensation of impending but not actual loss of consciousness) as a reason for ED visit.

Exclusion Criteria

• persistent altered mental status
• alcohol or illicit drug-related loss of consciousness
• definite seizure, and transient loss of consciousness caused by head trauma.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A Taylor, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

Keller C, Tristano JM, De Lorenzo R, et al.

Reference Type: BACKGROUND

Grossman SA, Fischer C, Lipsitz LA, Mottley L, Sands K, Thompson S, Zimetbaum P, Shapiro NI. Predicting adverse outcomes in syncope. J Emerg Med. 2007 Oct;33(3):233-9. doi: 10.1016/j.jemermed.2007.04.001. Epub 2007 Jul 5.

Reference Type: BACKGROUND

PMID: 17976548 (View on PubMed)

Dhatreecharan S, Azar P, Werner MS, et al.

Reference Type: BACKGROUND

Gabayan GZ, Derose SF, Asch SM, Chiu VY, Glenn SC, Mangione CM, Sun BC. Predictors of short-term (seven-day) cardiac outcomes after emergency department visit for syncope. Am J Cardiol. 2010 Jan 1;105(1):82-6. doi: 10.1016/j.amjcard.2009.08.654.

Reference Type: BACKGROUND

PMID: 20102895 (View on PubMed)

Martin NM, Picard MH. Use and appropriateness of transthoracic echocardiography in an academic medical center: a pilot observational study. J Am Soc Echocardiogr. 2009 Jan;22(1):48-52. doi: 10.1016/j.echo.2008.10.003. Epub 2008 Nov 20.

Reference Type: BACKGROUND

PMID: 19022620 (View on PubMed)

Christopher L Moore and Joshua A Copel.

Reference Type: BACKGROUND

Other Identifiers

1110009227

Identifier Type: -

Identifier Source: org_study_id