A Randomized, Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Patients Presenting to the Emergency Department With Syncope
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time to Final Emergency Department Disposition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •persistent altered mental status
- •alcohol or illicit drug-related loss of consciousness
- •definite seizure, and transient loss of consciousness caused by head trauma.
研究组 & 干预措施
Immediate Ultrasound
A point-of-care ultrasound will be performed during the initial evaluation of the patient after randomization (Defined as Time 0)
干预措施: Point-of-Care Ultrasound (Other)
Delayed Ultrasound
A point-of-care ultrasound will be performed by the provider at 60 min after initial randomization
干预措施: Point-of-Care Ultrasound (Other)
结局指标
主要结局
Time to Final Emergency Department Disposition
时间窗: Time at which an admit or discharge order is placed within the electronic medical record (estimated 2-3 hours)
次要结局
- 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(End of Emergency Department Encounter (estimated time frame 1- 6 hours))
- Information Content provided by Point-of-Care Ultrasound(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(estimated time frame (0-6 hours))