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临床试验/NCT06729528
NCT06729528已完成不适用

Diagnostic Value of PePCI and ManTIS Scores in Whole-Body Computed Tomography (WBCT) Decision-Making for Pediatric Trauma Patients in the Emergency Department

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 684 人开始时间: 2024年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
684
试验地点
1
主要终点
Whole Body Computed Tomography Need

研究概览

简要总结

Pediatric trauma assessment is challenging due to difficulties in obtaining information, which increases the need for unnecessary imaging. Trauma-related injuries remain a significant cause of death in children. Although whole-body computed tomography (CT) is frequently used due to a lower threshold for imaging, issues such as high radiation exposure arise.

To reduce unnecessary radiation exposure in pediatric trauma patients, scoring systems such as PePCI (Pediatric Polytrauma CT Indication Score) and ManTIS (Manchester Trauma Imaging Score) have been developed. These studies have demonstrated their effectiveness in predicting the need for CT scans and preventing unnecessary examinations. However, both studies are retrospective analyses limited to a single region. Therefore, a prospective study is planned in Türkiye to evaluate the reliability and applicability of these scoring systems and their real-world benefits.

详细描述

The assessment of trauma in children is challenging due to difficulties in obtaining information about the mechanism and process of trauma, which leads doctors to perform more imaging. Although the incidence of fatal injuries in children has decreased in the last decade, trauma-related injuries remain a leading cause of death among children over one-year-old. Due to the lower imaging threshold in children compared to adults, whole-body computed tomography (WBCT) is frequently used. WBCT is an essential tool for the rapid diagnosis of injuries, especially in hemodynamically unstable pediatric multi-trauma patients.

The most accurate criteria for activating the trauma team in pediatric trauma patients are still being debated. According to the Advanced Trauma Life Support (ATLS) guidelines, the trauma team is activated based on the mechanism of injury; thus, WBCT is performed even in hemodynamically stable pediatric patients. This situation leads to unnecessary radiation exposure, increased costs, and resource wastage. Although the mechanism of injury does not constitute a sufficient indication for WBCT in pediatric patients, many trauma patients are evaluated with WBCT to avoid missing potential injuries.

In pediatric emergency department patients, it is known that WBCT is not associated with a reduction in mortality but is linked to high radiation exposure and increased lifetime risk for leukemia, solid cancers, and brain tumors. Therefore, although we know the benefits of targeted emergency CT scans, the usefulness of WBCT imaging for pediatric trauma patients is debated.

The severity of injuries, especially in multi-trauma patients, is classified using the Injury Severity Score (ISS). The ISS is based on an anatomical ordinal scale ranging from 1 to 75 points, with low scores representing mild injuries and high scores representing severe and fatal injuries. Generally, an ISS >15 indicates serious injuries. This scoring system is also applicable to children and adolescents. However, pediatric patients show lower mortality for the same ISS compared to adults, attributed to physiological response differences between adults and children. Therefore, a new classification for injury severity in pediatric patients has been proposed. While an ISS >15 in adults indicates serious injury, an ISS >23 in the pediatric population indicates serious injury, and patients with an ISS >26 may have functional impairments at discharge.

To reduce unnecessary radiation exposure and prevent resource wastage in pediatric trauma patients, a new study was conducted by Strahl and colleagues. The study involved pediatric emergency patients with high-energy trauma mechanisms at a Level I trauma center in Germany. As a result of this study, a pediatric polytrauma CT indication score (PePCI) was developed to analyze pediatric trauma patients and reduce radiation exposure. The performance of this score was compared with the ISS. In this study, cases were screened retrospectively. It was found that WBCT was applied to 243 pediatric trauma patients. If the PePCI score had been applied to pediatric trauma patients, it could have been determined that WBCT would not have been necessary for 76 of the 243 patients they screened. Moreover, no significant injuries would have been overlooked.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All pediatric trauma patients who present to the emergency red zone or are deemed appropriate for monitoring in the red zone during their emergency department visit.
  • Patients for whom consent to participate in the study is provided by their legal guardians (as children are not able to provide consent independently)

排除标准

  • Patients who have previously been included in the study.
  • Patients who refuse treatment before their assessment is completed or withdraw their consent to participate in the study.
  • Patients with incomplete study data.
  • Patients with penetrating injuries

研究组 & 干预措施

Traumatic pediatric patients

Patients under 18 years old present to the emergency department red area due to trauma.

干预措施: The PePCI and ManTIS scores (Diagnostic Test)

结局指标

主要结局

Whole Body Computed Tomography Need

时间窗: through study completion, an average of 8 months

Patients will be evaluated by an expert panel, which will include three emergency medicine specialists. The panel will assess all relevant clinical data, including trauma history, physical examination findings, laboratory results, imaging outcomes, consultations, and final dispositions. Based on this comprehensive evaluation, the panel will determine whether the patient requires WBCT. As a result, the primary outcome will be recorded as a binary measure: either the patient requires WBCT or does not require WBCT.

次要结局

未报告次要终点

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Kudu

Assistant Professor

Marmara University Pendik Training and Research Hospital

研究点 (1)

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