Clinical trial NCT01671371: Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope
Official title: A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Syncope
Keywords: syncope
point of care
ultrasound
echocardiography
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Time to Final Emergency Department Disposition
timeFrame: Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)
Secondary outcomes:
measure: Time to therapeutic intervention
timeFrame: At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours)
measure: Time to clinical procedure
timeFrame: At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours)
measure: Number and Type of other imaging studies
timeFrame: End of Emergency Department Encounter (estimated time frame 1- 6 hours)
measure: Information Content provided by Point-of-Care Ultrasound
timeFrame: After performance of point-of-care ultrasound (estimated time frame 1- 6 hours)
measure: Number and type of laboratory studies
timeFrame: estimated time frame 0-6 hours
measure: Number of and time to consultant services
timeFrame: estimated time frame (0-6 hours)
Other outcomes:
measure: Short Term Adverse Outcome
timeFrame: 7 days from Emergency Department Visit
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard A Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keller C, Tristano JM, De Lorenzo R, et al.
citation: 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.
citation: Dhatreecharan S, Azar P, Werner MS, et al.
citation: 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.
citation: 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.
citation: Christopher L Moore and Joshua A Copel.