RECRUITING
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Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
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.
Conditions:
🦠 Cervical Spine Injury
🗓️ Study Start (Actual) 12 December 2018
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 September 2026
👥 Enrollment (Estimated) 22222
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States
📍 Oakland, California, United States
📍 Sacramento, California, United States
📍 Denver, Colorado, United States
📍 Washington, District of Columbia, United States
📍 Atlanta, Georgia, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Saint Louis, Missouri, United States
📍 Cincinnati, Ohio, United States
📍 Columbus, Ohio, United States
📍 Columbus, Ohio, United States
📍 Dallas, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Houston, Texas, United States
📍 Salt Lake City, Utah, United States
📍 Milwaukee, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: N/A to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 September 2021
  • First Submitted that Met QC Criteria 9 September 2021
  • First Posted 20 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 February 2024
  • Last Update Posted 22 February 2024
  • Last Verified February 2024
I'm interested ...!!