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

A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope

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.

Study Overview

• Status: Terminated
• Conditions: Syncope
• Intervention / Treatment: Other: Point-of-Care Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Immediate Ultrasound; A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)	Other: 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
Other: Delayed Ultrasound; A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Final Emergency Department Disposition	Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to therapeutic intervention		At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours)
Time to clinical procedure		At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours)
Number and Type of other imaging studies	Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.	End of Emergency Department Encounter (estimated time frame 1- 6 hours)
Information Content provided by Point-of-Care Ultrasound	calculating from pre and post test probability estimates and the number of diagnoses	After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)
Number and type of laboratory studies		estimated time frame 0-6 hours
Number of and time to consultant services	Number of consults obtained and the time frame in which the consults were performed	estimated time frame (0-6 hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Term Adverse Outcome	Adverse outcome defined as death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ED visit and hospitalization for a related event.	7 days from Emergency Department Visit

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Richard A Taylor, M.D., Yale University

Publications and helpful links

General Publications

• Keller C, Tristano JM, De Lorenzo R, et al.
• 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.
• Dhatreecharan S, Azar P, Werner MS, et al.
• 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.
• 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.
• Christopher L Moore and Joshua A Copel.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: August 20, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 29, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; syncope; point of care; echocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Unconsciousness; Consciousness Disorders; Emergencies; Syncope
• Other Study ID Numbers: 1110009227

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No