Cervical Spine Injury
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Julie Leonard
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Spine Injury | CSI diagnosed within 21 days of emergency department presentation | The primary outcome used to derive and validate the prediction rule is the presence of cervical spine injury (CSI) defined as vertebral fracture, ligamentous injury, intraspinal hemorrhage, or spinal cord injury involving the cervical region of the spine (occiput to the 7th cervical vertebra, including ligaments attaching the 7th vertebrae to the 1st thoracic vertebra) on any c-spine imaging modality, including x-ray, skeletal survey, CT scan, and/or MRI. |
Countries
United States
Participant flow
Pre-assignment details
In the database, fourteen subjects were found to be duplicate enrollments.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 22430 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2618 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 111 Participants |
| Race (NIH/OMB) Asian | 220 Participants |
| Race (NIH/OMB) Black or African American | 4100 Participants |
| Race (NIH/OMB) More than one race | 411 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 99 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1726 Participants |
| Race (NIH/OMB) White | 10906 Participants |
| Region of Enrollment United States | 22430 Participants |
| Sex: Female, Male Female | 9362 Participants |
| Sex: Female, Male Male | 6855 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 60 / 11,857 | 54 / 10,573 |
| other Total, other adverse events | 0 / 11,857 | 0 / 10,573 |
| serious Total, serious adverse events | 0 / 11,857 | 0 / 10,573 |
Outcome results
None listed