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

Recruiting

• Conditions: Cervical Spine Injury

• Registration Number: NCT05049330
• Lead Sponsor: Julie Leonard

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22222

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers.	8/1/2018-7/31/2023

Trial Locations

Locations (18)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

UCSF Benioff Children's Hospital; 🇺🇸 Oakland, California, United States

Children's Hospital UC Davis Health; 🇺🇸 Sacramento, California, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

CS Mott Children's Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Washington University School of Medicine in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

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