Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Adverse Events at 5 days
研究概览
简要总结
This study is an observational, prospective study examining the role point-of-care echocardiography of predicting short term adverse outcomes in emergency department patients with acute pulmonary embolism.
The primary objective is to assess the diagnostic performance of ultrasound-guided measures of right ventricular dilation (RVD) and strain in predicting clinical outcomes in acute PE.
The secondary objective is to investigate the utility of combining ultrasound-guided measures of RVD and the pulmonary embolism severity index (PESI) score in predicting adverse outcomes in acute PE.
详细描述
STUDY: Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
BACKGROUND
The clinical outcomes associated with pulmonary embolism (PE) vary widely. In the United States, most patients are admitted for inpatient therapy; however, there is evidence to suggest that outpatient therapy may be safe in patients with non-massive PEs. Appropriate outpatient treatment of patients with pulmonary emboli not only has the potential to increase patient satisfaction, but also has the potential to significantly reduce cost of care without compromising patient safety.
The pulmonary embolism severity index (PESI) is an externally validated prediction tool for mortality associated with PE. The PESI consists of 11 clinical parameters that are routinely available and stratifies patients into 5 risk categories, class I having the lowest risk of short-term mortality and class V having the highest. The PESI does not rely on imaging modalities to determine risk of adverse outcome within 30 days of initial PE diagnosis.
Predicting short-term adverse outcomes in PE is essential for proper disposition, namely hospitalization of at-risk patients and discharge of those with low likelihood of decompensation. Hariharan et al. evaluated the ability of PESI to predict short-term deterioration (<5 days) in patients with acute PE. The PESI demonstrated a sensitivity of 86% (95% CI 73-93%) for predicting short-term adverse events. Approximately 14% of patients deemed low-risk by PESI required short-term interventions. The authors concluded that risk stratification with PESI warrants further optimization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age >= 18 years of age
- •ED diagnosis of acute pulmonary embolism with identification on CT imaging
排除标准
- •Age <18 years of age
- •Inability to provide informed consent
- •Incarceration
- •Current PE previously diagnosed prior to index ED visit
结局指标
主要结局
Adverse Events at 5 days
时间窗: Within 5 days of presentation/enrollment
Composite of recurrent/worsening VTE (including PE or DVT), new cardiac dysrhythmia, major bleeding, return to the ED, death or need for critical interventions (including advanced cardiac life support, advanced respiratory support, vasopressor support, thrombolysis or new oxygen requirement occurring after initial presentation) occurring within 5 days of acute PE diagnosis
次要结局
- Adverse Events during Index Hospitalization(Between time of presentation/enrollment and discharge from index hospitalization)
- Adverse Events within 14 days(Within 14 days of presentation/enrollment)
- Adverse Events within 30 days(Within 30 days of presentation/enrollment)
研究者
Brent Becker
Research Director, Department of Emergency Medicine
WellSpan Health