Point-of-Care Ultrasound in the Emergency Department Evaluation of Syncope
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Syncope |
Other: Point-of-Care Ultrasound |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope |
- Time to Final Emergency Department Disposition [ Time Frame: Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours) ] [ Designated as safety issue: No ]
- Time to therapeutic intervention [ Time Frame: At onset of therapeutic interventions including but not limited to intravenous fluids and medications (estimated time frame 0 - 6 hours) ] [ Designated as safety issue: No ]
- Time to clinical procedure [ Time Frame: At onset of clinical procedures including but not limited to central line placement, pericardiocentesis, thoracentesis, etc. (estimated time frame 0-6 hours) ] [ Designated as safety issue: No ]
- Number and Type of other imaging studies [ Time Frame: End of Emergency Department Encounter (estimated time frame 1- 6 hours) ] [ Designated as safety issue: No ]Other imaging studies to included radiographs, additional point-of-care ultrasound, computed tomography, etc.
- Information Content provided by Point-of-Care Ultrasound [ Time Frame: After performance of point-of-care ultrasound (estimated time frame 1- 6 hours) ] [ Designated as safety issue: No ]calculating from pre and post test probability estimates and the number of diagnoses
- Number and type of laboratory studies [ Time Frame: estimated time frame 0-6 hours ] [ Designated as safety issue: No ]
- Number of and time to consultant services [ Time Frame: estimated time frame (0-6 hours) ] [ Designated as safety issue: No ]Number of consults obtained and the time frame in which the consults were performed
- Short Term Adverse Outcome [ Time Frame: 7 days from Emergency Department Visit ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Richard A Taylor, M.D. | 860-402-1276 | richard.taylor@yale.edu |
| United States, Connecticut | |
| Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Taylor richard.taylor@yale.edu | |
| Principal Investigator: | Richard A Taylor, M.D. | Yale University |
More Information
Publications:
| Responsible Party: | Richard Andrew Taylor, Assistant Professor of Emergency Medicine, Yale University |
| ClinicalTrials.gov Identifier: | NCT01671371 History of Changes |
| Other Study ID Numbers: | 1110009227 |
| Study First Received: | July 17, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
syncope point of care ultrasound echocardiography |
Additional relevant MeSH terms:
|
Emergencies Syncope Disease Attributes Pathologic Processes Unconsciousness |
Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013