Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool (C-Spine)

Julie Leonard

Status: Enrolling

Conditions: Cervical Spine Injury

Study type: Observational

Funder types: Other

Identifiers

NCT05049330

5R01HD091347

Details and patient eligibility

About

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.

Enrollment: 22,222 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

22,222 participants in 2 patient groups

Derivation Cohort

Description:

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

Validation Cohort

Description:

The validation cohort collected data to validate the clinical decision rule