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临床试验/NCT03359421
NCT03359421已完成不适用

Trauma Routing Algorithm for Pediatrics

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 4,801 人开始时间: 2017年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,801
试验地点
1
主要终点
Survival

研究概览

简要总结

Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. However, nearly half the US pediatric population lives over fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in many jurisdictions, few guidelines and little evidence dictate their appropriate use, especially with regard to pediatric trauma. Previous research is mixed regarding mortality benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous attempts to develop appropriate field triage criteria have failed due to poor sensitivity and specificity for identifying the critically injured child. The current high rate of overtriage is particularly concerning in today's cost-conscious medical community. This research study aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an enhanced screening tool for pre-hospital use to help determine which patients are suitable candidates for helicopter EMS transport.

详细描述

The North Carolina Trauma Registry will identify pediatric trauma patients between 0 and 18 years of age who presented directly to North Carolina Level 1 Trauma Centers from the field after sustaining injury from January 1st, 2013 and October 2017.

The analysis will be a retrospective cohort study by nature of the data set. Final methodology will be determined after Institutional Review Board approval and enlistment of statistical support through the Clinical and Translational Science Institute. Clinical and non-clinical factors will first be summarized with univariate analysis to provide a descriptive overview of the study population. These factors will include number of case-patients, demographics, scene address/location, time of injury, EMS agency involved, EMS call times, transport mechanism, time of transport, distance of transport, geographic area of injury, mechanism of injury, severity scores, Glasgow Coma Score, vital signs, receiving hospital name, and other variables. Similarly, interventions and outcomes will be compared between study groups through such factors such as length of emergency department stay, emergency department disposition, time to operating room, intubation status on arrival, administration of blood products, days of hospital stay, days of intensive care unit stay, days on ventilator, if viable organs were procured post-mortem, and mortality at given time points. Outcomes will be compared through regression analysis or related means.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
2 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pediatric trauma victims 0-16 years old who are reported in the North Carolina Trauma Registry after presenting to a North Carolina Trauma Center between January 1st, 2013 and October, 2017.

排除标准

  • •Interfacility transport patients are excluded

结局指标

主要结局

Survival

时间窗: approximately 1 month or less

Patient survival

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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