Trauma Routing Algorithm for Pediatrics

Completed

• Conditions: Pediatric All; Trauma

• Registration Number: NCT03359421
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. However, nearly half the US pediatric population lives over fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in many jurisdictions, few guidelines and little evidence dictate their appropriate use, especially with regard to pediatric trauma. Previous research is mixed regarding mortality benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous attempts to develop appropriate field triage criteria have failed due to poor sensitivity and specificity for identifying the critically injured child. The current high rate of overtriage is particularly concerning in today's cost-conscious medical community. This research study aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an enhanced screening tool for pre-hospital use to help determine which patients are suitable candidates for helicopter EMS transport.

Detailed Description

The North Carolina Trauma Registry will identify pediatric trauma patients between 0 and 18 years of age who presented directly to North Carolina Level 1 Trauma Centers from the field after sustaining injury from January 1st, 2013 and October 2017.

The analysis will be a retrospective cohort study by nature of the data set. Final methodology will be determined after Institutional Review Board approval and enlistment of statistical support through the Clinical and Translational Science Institute. Clinical and non-clinical factors will first be summarized with univariate analysis to provide a descriptive overview of the study population. These factors will include number of case-patients, demographics, scene address/location, time of injury, EMS agency involved, EMS call times, transport mechanism, time of transport, distance of transport, geographic area of injury, mechanism of injury, severity scores, Glasgow Coma Score, vital signs, receiving hospital name, and other variables. Similarly, interventions and outcomes will be compared between study groups through such factors such as length of emergency department stay, emergency department disposition, time to operating room, intubation status on arrival, administration of blood products, days of hospital stay, days of intensive care unit stay, days on ventilator, if viable organs were procured post-mortem, and mortality at given time points. Outcomes will be compared through regression analysis or related means.

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Primary Completion: 2017-12-15
• Study Completion: 2020-05-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4801

Inclusion Criteria

• Pediatric trauma victims 0-16 years old who are reported in the North Carolina Trauma Registry after presenting to a North Carolina Trauma Center between January 1st, 2013 and October, 2017.

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Exclusion Criteria

• Interfacility transport patients are excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	approximately 1 month or less	Patient survival

Trial Locations

Locations (1)

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States