NCT03359421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,801

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

18 days

First QC Date

November 27, 2017

Last Update Submit

December 8, 2021

Conditions

Keywords

prehospitalaeromedicaltraumaemshelicopter

Outcome Measures

Primary Outcomes (1)

  • Survival

    Patient survival

    approximately 1 month or less

Study Arms (2)

Aeromedical transport

Patients transported to trauma center by helicopter

Ground transport

Patients transported to trauma center by ground ambulance

Eligibility Criteria

Age2 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients \<16 years old involved in trauma that were transported to a North Carolina Trauma Center

You may qualify if:

  • 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.

You may not qualify if:

  • Interfacility transport patients are excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27057, United States

Location

Related Publications (16)

  • Arfken CL, Shapiro MJ, Bessey PQ, Littenberg B. Effectiveness of helicopter versus ground ambulance services for interfacility transport. J Trauma. 1998 Oct;45(4):785-90. doi: 10.1097/00005373-199810000-00031.

    PMID: 9783622BACKGROUND
  • Baxt WG, Moody P. The impact of a rotorcraft aeromedical emergency care service on trauma mortality. JAMA. 1983 Jun 10;249(22):3047-51.

    PMID: 6854826BACKGROUND
  • Biewener A, Aschenbrenner U, Rammelt S, Grass R, Zwipp H. Impact of helicopter transport and hospital level on mortality of polytrauma patients. J Trauma. 2004 Jan;56(1):94-8. doi: 10.1097/01.TA.0000061883.92194.50.

    PMID: 14749573BACKGROUND
  • Bledsoe BE, Wesley AK, Eckstein M, Dunn TM, O'Keefe MF. Helicopter scene transport of trauma patients with nonlife-threatening injuries: a meta-analysis. J Trauma. 2006 Jun;60(6):1257-65; discussion 1265-6. doi: 10.1097/01.ta.0000196489.19928.c0.

    PMID: 16766969BACKGROUND
  • Chappell VL, Mileski WJ, Wolf SE, Gore DC. Impact of discontinuing a hospital-based air ambulance service on trauma patient outcomes. J Trauma. 2002 Mar;52(3):486-91. doi: 10.1097/00005373-200203000-00012.

    PMID: 11901324BACKGROUND
  • Englum BR, Rialon KL, Kim J, Shapiro ML, Scarborough JE, Rice HE, Adibe OO, Tracy ET. Current use and outcomes of helicopter transport in pediatric trauma: a review of 18,291 transports. J Pediatr Surg. 2017 Jan;52(1):140-144. doi: 10.1016/j.jpedsurg.2016.10.030. Epub 2016 Oct 27.

    PMID: 27852453BACKGROUND
  • Floccare DJ, Stuhlmiller DF, Braithwaite SA, Thomas SH, Madden JF, Hankins DG, Dhindsa H, Millin MG. Appropriate and safe utilization of helicopter emergency medical services: a joint position statement with resource document. Prehosp Emerg Care. 2013 Oct-Dec;17(4):521-5. doi: 10.3109/10903127.2013.804139. Epub 2013 Jul 8.

    PMID: 23834231BACKGROUND
  • Lerner EB, Drendel AL, Cushman JT, Badawy M, Shah MN, Guse CE, Cooper A. Ability of the Physiologic Criteria of the Field Triage Guidelines to Identify Children Who Need the Resources of a Trauma Center. Prehosp Emerg Care. 2017 Mar-Apr;21(2):180-184. doi: 10.1080/10903127.2016.1233311. Epub 2016 Oct 6.

    PMID: 27710155BACKGROUND
  • Michailidou M, Goldstein SD, Salazar J, Aboagye J, Stewart D, Efron D, Abdullah F, Haut ER. Helicopter overtriage in pediatric trauma. J Pediatr Surg. 2014 Nov;49(11):1673-7. doi: 10.1016/j.jpedsurg.2014.08.008. Epub 2014 Nov 6.

    PMID: 25475816BACKGROUND
  • Mitchell AD, Tallon JM, Sealy B. Air versus ground transport of major trauma patients to a tertiary trauma centre: a province-wide comparison using TRISS analysis. Can J Surg. 2007 Apr;50(2):129-33.

    PMID: 17550717BACKGROUND
  • Moront ML, Gotschall CS, Eichelberger MR. Helicopter transport of injured children: system effectiveness and triage criteria. J Pediatr Surg. 1996 Aug;31(8):1183-6; discussion 1187-8. doi: 10.1016/s0022-3468(96)90114-1.

    PMID: 8863261BACKGROUND
  • Potoka DA, Schall LC, Gardner MJ, Stafford PW, Peitzman AB, Ford HR. Impact of pediatric trauma centers on mortality in a statewide system. J Trauma. 2000 Aug;49(2):237-45. doi: 10.1097/00005373-200008000-00009.

    PMID: 10963534BACKGROUND
  • Sathya C, Alali AS, Wales PW, Scales DC, Karanicolas PJ, Burd RS, Nance ML, Xiong W, Nathens AB. Mortality Among Injured Children Treated at Different Trauma Center Types. JAMA Surg. 2015 Sep;150(9):874-81. doi: 10.1001/jamasurg.2015.1121.

    PMID: 26106848BACKGROUND
  • Stewart CL, Metzger RR, Pyle L, Darmofal J, Scaife E, Moulton SL. Helicopter versus ground emergency medical services for the transportation of traumatically injured children. J Pediatr Surg. 2015 Feb;50(2):347-52. doi: 10.1016/j.jpedsurg.2014.09.040. Epub 2014 Oct 1.

    PMID: 25638635BACKGROUND
  • Sullivent EE, Faul M, Wald MM. Reduced mortality in injured adults transported by helicopter emergency medical services. Prehosp Emerg Care. 2011 Jul-Sep;15(3):295-302. doi: 10.3109/10903127.2011.569849. Epub 2011 Apr 27.

    PMID: 21524205BACKGROUND
  • Webman RB, Carter EA, Mittal S, Wang J, Sathya C, Nathens AB, Nance ML, Madigan D, Burd RS. Association Between Trauma Center Type and Mortality Among Injured Adolescent Patients. JAMA Pediatr. 2016 Aug 1;170(8):780-6. doi: 10.1001/jamapediatrics.2016.0805.

    PMID: 27368110BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaWounds and Injuries

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jason Stopyra, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

November 27, 2017

Primary Completion

December 15, 2017

Study Completion

May 31, 2020

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations