NCT01339702已完成不适用
Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,873
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.
详细描述
- Significance: Approximately 1.4 million victims of Traumatic Brain Injury (TBI) are seen in emergency departments each year in the U.S. and, of those, 50,000 die and 235,000 are hospitalized. A least 2% of the U.S. population has a TBI-related long-term need for help to perform activities of daily living. There is growing evidence that the management of TBI in the early minutes after injury profoundly impacts outcome. This has led to the promulgation of evidence-based TBI treatment guidelines by authoritative national and international scientific bodies. Reports on guideline implementation in the hospital setting are very promising. However, no studies have evaluated their impact in the prehospital setting. While randomized prehospital trials to identify the effectiveness of the guidelines would clearly be optimal, the strong indirect evidence currently precludes withholding guideline therapy because of ethical considerations. Thus a large, prospective, historically controlled, observational study is the best methodology currently available to evaluate the effectiveness of implementing the guidelines in the prehospital setting.
- Specific Aim: To test the hypothesis that implementation of the TBI guidelines in a statewide EMS system will reduce mortality and improve non-mortality outcomes in adults and children with moderate to severe TBI.
- Objective #1: Implement the nationally-vetted TBI guidelines across a broad variety of EMS systems (urban, suburban and rural) throughout the State of Arizona. This will be accomplished through the statewide collaboration between the University of Arizona, the Arizona Department of Health Services, and local EMS agencies responding to 85% of the state's population. This will mirror the approach that has been successfully employed to study and document a tripling of patient survival from out-of-hospital cardiac arrest in the state.
- Objective #2: Collect prehospital EMS and trauma center data on severe TBI patients cared for by participating EMS agencies to determine pre-implementation and post-implementation injury severity/risk-adjustment measures and outcomes.
- Objective #3: Evaluate the impact of prehospital guideline implementation on the following outcomes: 1) Overall mortality (primary outcome), 2) mortality among patients who are intubated prior to hospital arrival, and 3) non-mortality outcomes such as hospital/intensive care unit length of stay, ventilator days, and patient disposition.
- Relevance/health impact: The societal burden of TBI is immense. While the potential for dramatically reducing morbidity and mortality by early treatment appears to be great, the effectiveness of the prehospital guidelines remains unproven. Demonstrating the impact of guideline therapy would potentially lead to widespread implementation of the effective interventions. This could dramatically reduce morbidity and mortality from this major public health problem. On the other hand, if the guidelines are not effective despite confirmed implementation across a wide variety of EMS systems throughout the entire state, this would provide the ethical basis for conducting future randomized trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of ≥3, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy.
排除标准
- •Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis).
结局指标
主要结局
Survival
时间窗: hospital discharge
Participants will be followed for the duration of hospital stay. The average time from admission to either discharge or death is expected to be approximately 3 weeks.
次要结局
- ventilator days(during hospitalization)
- hospital length of stay(discharge from hospital)
- Intensive care unit length of stay(admission to ICU to transfer from ICU)
- Patient disposition(hospital discharge)
研究者
Daniel Spaite
Professor of Emergency Medicine
University of Arizona
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial HemorrhageTraumatic Intracranial HemorrhageBrain InjuriesNCT05609721Umeå University2,044
已完成
不适用
Prehospital Traumatic Brain InjuryTraumatic Brain InjuryNCT01454648Tampere University Hospital458
已完成
不适用
The Prophylactic Hypothermia Trial to Lessen Traumatic Brain InjuryBrain Injuries, TraumaticNCT00987688Australian and New Zealand Intensive Care Research Centre511
已完成
不适用
Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain InjuryTraumatic Brain InjuryNCT01132937National Institute of Neurological Disorders and Stroke (NINDS)886
Unknown
不适用
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP MonitoringBrain Electrical Impedance;Non-invasive Intracranial PressureNCT02027857Xijing Hospital60