Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

Study Overview
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Brief Summary
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Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.

Official Title
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Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

Conditions
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Cervical Spine Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0-17 years Known or suspected exposure to blunt trauma At least one of the following applies to the patient: Undergoing trauma team evaluation Transported from the scene to participating facility by EMS Undergoing cervical spine imaging at participating facility Transferred to participating facility with cervical spine imaging Exclusion Criteria: Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Derivation Cohort<br>The derivation cohort collected data to derive the clinical decision rule. | |
| Validation Cohort<br>The validation cohort collected data to validate the clinical decision rule | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers |  | 8/1/2018 - 7/31/2022 | 
| Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma using prospective observational data obtained from ED providers |  | 8/1/2020-7/31/2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers. |  | 8/1/2018-7/31/2023 |