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临床试验/NCT02218983
NCT02218983Unknown不适用

The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation

Riverside University Health System Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
length of stay in the intensive care unit

研究概览

简要总结

Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in critical care. First introduced for volume assessment in nephrology and cardiology, it is now being researched in emergency and critical care. Data is still evolving in its use in initial trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but utility of its measurement on U/S in the emergency department still has some controversy. In trauma specifically, small studies suggests benefit to the use of U/S to predict volume status, and most of these data are from one author. It is not known if this can be applied more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE, SonoSite Ultrasound) has been studied in several small studies, and only one small randomized controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one group, it is not known if it can be applied to all trauma populations.

Research question:

Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as well as or better than other methods of organ perfusion?

Hypotheses:

  1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital and ICU stays, transfusions, and mortality).
  2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator, number of and transfusions better than other methods of organ perfusion (tachycardia, hypotension, lactate, lactate clearance, creatinine, base deficit).

研究设计

研究类型
Interventional
分配方式
Non 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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients arriving to trauma bay aged 18 or higher
  • Hypotensive (systolic blood pressure (SBP) < 90 mmHg or mean arterial pressure (MAP) < 65, on 2 measurements)
  • Respiratory failure (requiring mechanical ventilation)

排除标准

  • Unable to draw blood before transfusion or fluid challenge
  • Patient arrests within 10 minutes of arrival
  • Note: If inferior vena cava (IVC) not visible on ultrasound (U/S), pt will go to non-IVC group.

结局指标

主要结局

length of stay in the intensive care unit

时间窗: length of stay in the intensive care unit, not to exceed 30 days

次要结局

  • mortality (death)(mortality (death) during hospital stay, not to exceed 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aron Depew, MD

Principal Investigator

Riverside University Health System Medical Center

研究点 (2)

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