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unable to meet enrollment projections
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Ultrasound | Other | A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0) |
|
| Delayed Ultrasound | Other | A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care Ultrasound | 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 |
| Measure | Description | 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) |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Taylor, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Keller C, Tristano JM, De Lorenzo R, et al. | ||
| 17976548 | 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. | |
| Background | Dhatreecharan S, Azar P, Werner MS, et al. | ||
| 20102895 |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| 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) |
| 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. |
| 19022620 | Background | 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. |
| Background | Christopher L Moore and Joshua A Copel. |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |