Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22222
- 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
- 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)
UPMC Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Hospital Colorado
🇺🇸Denver, Colorado, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
CS Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital UC Davis Health
🇺🇸Sacramento, California, United States
UCSF Benioff Children's Hospital
🇺🇸Oakland, California, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
UT Southwestern Medical Center
🇺🇸Dallas, Pennsylvania, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States