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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

22222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-12

Study Completion Date

2026-09-01

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.

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Detailed Description

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Conditions

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Cervical Spine Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Derivation Cohort

The derivation cohort collected data to derive the clinical decision rule.

No interventions assigned to this group

Validation Cohort

The validation cohort collected data to validate the clinical decision rule

No interventions assigned to this group

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