Efficacy of Ultrasound to Guide Management During a Rapid Response Event
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time in shock
研究概览
简要总结
Rapid response team systems have been implemented in numerous hospitals throughout the world with the goal of improving the identification and safety of hospitalized patients who are clinically deteriorating. Despite their theoretical benefit, rapid response systems have not been proven in the medical literature to ultimately change outcomes.
The traditional physical exam is helpful in evaluating and treating unstable medical patients during these types of events but has significant limitations of deceased sensitivity and specificity of findings. Ultrasound is a known tool for more accurately assessing patients in shock and respiratory failure in the ICU by highly trained operators but to the investigators knowledge has not been studied in the setting of rapid response events on hospital wards by critical care fellows after focused training. The investigators aim to assess the impact of ultrasound performed by critical care fellows during rapid response events.
详细描述
This is an randomized controlled trial to determine if portable critical care ultrasound use is feasible, if its findings change clinical decision making by critical care fellows and whether ultrasound can improve patient outcomes during rapid response events at Beth Israel Medical Center.
Patients for whom a rapid response has been called for cardiac or respiratory failure will be randomized to either have a bedside ultrasound performed by a critical care fellow at the time of rapid response or to undergo a bedside ultrasound only if clinically indicated and specifically requested by the RRT leader.
For all patients on whom a rapid response is called with shock or respiratory failure who are randomized to the intervention group, a designated ultrasound critical care fellow will document their ranked top 2 preliminary cause for either shock or respiratory failure on a data collection instrument (DCI). These clinical (i.e. pre-ultrasound) diagnoses will be based on history, physical exam and all ancillary testing available prior to ultrasound performance. Available ancillary testing will be documented.
An ultrasound exam will then be performed by the designated ultrasound fellow using a portable hand-carried unit (GE Vscan) and the findings documented on the same DCI. The GE Vscan will be used for all ultrasounds performed during this study. The ultrasound study will take approximately 5 -10 minutes and will not interfere with alternative evaluation or treatment modalities deemed to be necessary during the rapid response.
The critical care ultrasound fellow will then provide the RRT leader team with their 2 most likely post ultrasound diagnosis for shock and respiratory failure and then document these on the DCI. Any changes to management made as a result of the ultrasound exam, including all new ancillary tests and therapeutic interventions will be recorded.
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
- None
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
- •Patients for whom a rapid response is called who have:
- •Hemodynamic instability as defined by:
- •Systolic blood pressure less than 90 mmHg or less than 40 mmHg from previously established baseline
- •Heart rate greater than 130 beats per minute
- •Known elevated lactate above normal value.
- •Hypercapnic or hypoxemic respiratory failure as judged by the responding critical care fellow.
排除标准
- •Patients for whom a rapid response has been called who:
- •Are not hemodynamically unstable and not in respiratory failure.
- •Are hemodynamically unstable but who have an obvious source of bleeding to explain hemodynamic instability.
结局指标
主要结局
Time in shock
时间窗: Immediately after rapid response
Time on vasopressors following the rapid response event and for 8 weeks thereafter.
Time in respiratory failure
时间窗: From immediately after rapid response event and for 8 weeks thereafter.
Time period that the patient requires invasive or non-invasive mechanical ventilation.
次要结局
- Mortality(During hospitaliztion or for 8 weeks thereafter.)
- Diagnosis variation following ultrasound(Immediately after ultrasound and for 1 day thereafter.)
- Utilization of chest x-ray(Following rapid response event and one day thereafter.)
- Utilization of CT scan(Following rapid response event for one day thereafter.)
- Length of stay(Following rapid response event and for 8 weeks thereafter.)
- Management changes following ultrasound performance(Immediately following ultrasound and for one day thereafter.)