Clinical trial NCT06729528: Diagnostic Value of Whole-Body Computed Tomography (WBCT) Scores in Pediatric Trauma Patients
Official title: Diagnostic Value of PePCI and ManTIS Scores in Whole-Body Computed Tomography (WBCT) Decision-Making for Pediatric Trauma Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Whole Body Computed Tomography Imaging
Lead sponsor: Marmara University Pendik Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 435
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all pediatric trauma cases that present to the red area of the emergency department.

Brief summary: 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.

Detailed description: 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.

Another single-center study conducted by Davies and colleagues in the United Kingdom (UK) demonstrated that a large patient group in the UK is exposed to unnecessary radiation. This situation is thought to increase the risk of life-threatening outcomes, such as malignancy, in the future. With appropriate evaluation, it has been shown that WBCT imaging may not be necessary for some trauma patients. A scoring system called the Manchester Trauma Imaging Score (ManTIS) has been developed to facilitate this evaluation. The ManTIS score has been shown to safely reduce the number of unnecessary WBCTs in the young patient group.

Although these studies have shown that the PePCI and ManTIS scores effectively predict the need for WBCT and prevent unnecessary scans, they have been conducted in a single region. The developed scoring systems are only applicable to specific geographical areas. Additionally, both studies were retrospective. Therefore, this study plans to prospectively evaluate the reliability, applicability, and practicality of these scores in clinical practice in Türkiye, assessing their real-life benefits.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Whole Body Computed Tomography Need
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
References:
citation: Strahl A, Willemsen JF, Schoof B, Reinshagen K, Frosch KH, Wintges K. The paediatric polytrauma CT-indication (PePCI)-score-Development of a prognostic model to reduce unnecessary CT scans in paediatric trauma patients. Injury. 2024 May;55(5):111494. doi: 10.1016/j.injury.2024.111494. Epub 2024 Mar 11.
citation: Davies RM, Scrimshire AB, Sweetman L, Anderton MJ, Holt EM. A decision tool for whole-body CT in major trauma that safely reduces unnecessary scanning and associated radiation risks: An initial exploratory analysis. Injury. 2016 Jan;47(1):43-9. doi: 10.1016/j.injury.2015.08.036. Epub 2015 Sep 1.