Multicenter, Prospective Development of a Clinical Prediction Model to Determine Which Children Can Safely Avoid Abdominal CT Scanning During the Initial Evaluation of Blunt Abdominal Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,800
- 试验地点
- 14
- 主要终点
- Intra-abdominal Injury (IAI)
研究概览
简要总结
The submitted proposal is designed to reduce morbidity and mortality to injured children. Significant variability in the initial trauma assessment exists among institutions. The proposed project is a prospective, observational, multi-institutional study of children following blunt abdominal trauma. The specific goals of the project are to: 1) Document history, physical exam findings, imaging, and laboratory values, which are available to physicians during the initial trauma resuscitation prior to a decision on whether to order an abdominal computed tomography (CT) to evaluate for potential intra-abdominal injury; and 2) Derive and validate a multi-variable clinical prediction rule based on data variables readily available during the pediatric trauma resuscitation to identify patients at low risk for intra-abdominal injury, in which unnecessary CT might safely be avoided. Information from this study could be used to develop a more standardized approach to the evaluation for intra-abdominal injury following blunt trauma in children. This information could lead to significant improvement in the early recognition of injury and to improved resource utilization.
详细描述
The proposed research project is a prospective, observational study. Data will be collected from each institution and entered into a secure REDCap database. Two phases of data collection will occur: 1) patient demographics and specific clinical variables which may be associated with IAI which are available and recorded during the initial trauma evaluation 2) laboratory and imaging results available after the initial assessment, identified injuries, patient disposition, interventions and outcomes.
Primary Outcome Variables: 1) Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia)) 2) IAI requiring intervention (abdominal operation, angio-embolization, blood transfusion)
Time Course: The initial data collection period will extend for one year. Data will be recorded in a password protected redcap database which is readily available online to all participating institutions.
Study setting: Eleven Level One Pediatric Trauma Centers
Data collection points: demographics (age, mechanism, alert level), physical exam, labs (AST, HCT, amylase, UA, base deficit), FAST, imaging results, injuries, outcomes (admission, ICU admit, need for intervention, missed injuries, ISS).
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
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting as a Trauma system activation with suspicion for blunt abdominal trauma. (Fall >10 feet; Motor vehicle accident >40mph, pedestrian struck by auto, Motor vehicle crash with ejection or death in vehicle or rollover, assault, bicycle accident, ATV accident).
- •<16 years of age
- •The need to activate the trauma system is dictated by the Emergency Department physician
- •Consults called to the department of surgery for suspicion of intraabdominal traumatic injury
排除标准
- •16 years of age or older
- •Burn injury
- •Penetrating injury
- •CT A/P performed prior to arrival
- •Presentation >6 hours from time of injury
- •Pregnancy
- •Isolated head injury
- •Fall <10 feet with no concern for intraabdominal injury
- •Isolated extremity injury
结局指标
主要结局
Intra-abdominal Injury (IAI)
时间窗: 30 days from time of trauma
Intra-abdominal injury (IAI) (presence of solid or hollow organ injury (spleen, liver, kidney, GI tract, adrenal, pancreas, intra-abdominal vascular structure, bladder, ureter, gallbladder, abdominal wall fascia))
Intraabdominal Injury (IAI) requiring intervention
时间窗: 30 days from time of trauma
Intra-abdominal injury (IAI) requiring intervention (Laparoscopy or Laparotomy, angio-embolization, blood transfusion for IAI)
次要结局
未报告次要终点