NCT03940443

Brief Summary

Introduction: Patients suffering a time-critical medical condition require rapid prehospital assessment and treatment and most often quick transportation to definitive care. This can be decisive for patient outcome. In order to minimize time from assessment to treatment, thus lowering mortality and morbidity, it is important to have a well-coordinated chain of care. The efficient use of Ground Emergency Medical Services (GEMS) and Helicopter Emergency Medical Services (HEMS) is essential in such a chain of care. Objectives: The aim is to describe differences in mortality, morbidity, assessment and treatment of two time-critical conditions, traumatic brain injury (TBI) and acute myocardial infarction (MI), in patients assessed by GEMS and HEMS respectively. Method: The project consists of a descriptive observational study and comparative cohort study. Inclusion criteria are patients considered to be suffering from TBI and acute MI, which are treated by GEMS or HEMS in the regions of Uppsala, Jämtland/Härjedalen, Dalarna and Värmland. Clinical significance: The results expect to be the basis for further studies aiming to optimize the utilization of GEMS and HEMS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 13, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

March 13, 2019

Last Update Submit

February 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    The primary outcome is mortality, and will be controlled with measure of time from dispatch to assessment and treatment to patient arrival at the receiving medical facility. Timeframe from inclusion until death, up to 30 days. The outcome will be reported in numbers by proportion of participants and with tables in percentage.

    January 1st, 2017 to December 31st, 2018

Other Outcomes (1)

  • Comorbidity

    January 1st, 2017 to December 31st, 2018

Study Arms (1)

Ground Emergency Medical Services

Patients suffering TBI or acute MI and has been treated by GEMS dispatched by an emergency dispatch centre.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients considered to be suffering a TBI or acute MI and been treated by either GEMS or HEMS.

You may qualify if:

  • Patients suffering from a time-critical condition:
  • Cardiac arrest
  • Acute myocardial infarction
  • Severe chest pain
  • Stroke
  • Severe respiratory difficulties
  • Severe trauma

You may not qualify if:

  • Patient in a non time-critical condition:
  • Minor trauma
  • Minor respiratory difficulties
  • Minor chest pain
  • Minor neurologic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Dalarna

Falun, 791 82, Sweden

RECRUITING

Related Publications (18)

  • Krafft T, Garcia Castrillo-Riesgo L, Edwards S, Fischer M, Overton J, Robertson-Steel I, Konig A. European Emergency Data Project (EED Project): EMS data-based health surveillance system. Eur J Public Health. 2003 Sep;13(3 Suppl):85-90. doi: 10.1093/eurpub/13.suppl_1.85.

    PMID: 14533755BACKGROUND
  • Georgette E, Simon B, James R. HEMS dispatch: A systematic review. Trauma. 2018;20(1):8.

    BACKGROUND
  • Suserud B-O, Lundberg L. Prehospital akutsjukvård. 2 ed. Stockholm: Liber; 2016. 560 p.

    BACKGROUND
  • Delgado MK, Staudenmayer KL, Wang NE, Spain DA, Weir S, Owens DK, Goldhaber-Fiebert JD. Cost-effectiveness of helicopter versus ground emergency medical services for trauma scene transport in the United States. Ann Emerg Med. 2013 Oct;62(4):351-364.e19. doi: 10.1016/j.annemergmed.2013.02.025. Epub 2013 Apr 9.

    PMID: 23582619BACKGROUND
  • Andruszkow H, Hildebrand F, Lefering R, Pape HC, Hoffmann R, Schweigkofler U. Ten years of helicopter emergency medical services in Germany: do we still need the helicopter rescue in multiple traumatised patients? Injury. 2014 Oct;45 Suppl 3:S53-8. doi: 10.1016/j.injury.2014.08.018.

    PMID: 25284235BACKGROUND
  • Andruszkow H, Schweigkofler U, Lefering R, Frey M, Horst K, Pfeifer R, Beckers SK, Pape HC, Hildebrand F. Impact of Helicopter Emergency Medical Service in Traumatized Patients: Which Patient Benefits Most? PLoS One. 2016 Jan 15;11(1):e0146897. doi: 10.1371/journal.pone.0146897. eCollection 2016.

    PMID: 26771462BACKGROUND
  • Blankenship JC, Haldis TA, Wood GC, Skelding KA, Scott T, Menapace FJ. Rapid triage and transport of patients with ST-elevation myocardial infarction for percutaneous coronary intervention in a rural health system. Am J Cardiol. 2007 Sep 15;100(6):944-8. doi: 10.1016/j.amjcard.2007.04.031. Epub 2007 Jul 2.

    PMID: 17826374BACKGROUND
  • Hesselfeldt R, Pedersen F, Steinmetz J, Vestergaard L, Simonsen L, Jorgensen E, Clemmensen P, Rasmussen LS. Implementation of a physician-staffed helicopter: impact on time to primary PCI. EuroIntervention. 2013 Aug 22;9(4):477-83. doi: 10.4244/EIJV9I4A77.

    PMID: 23965353BACKGROUND
  • Pathan SA, Soulek J, Qureshi I, Werman H, Reimer A, Brunko MW, et al. Helicopter EMS and rapid transport for ST-elevation myocardial infarction: The HEARTS study. Journal of Emergency Medicine, Trauma and Acute Care. 2017;2017(1):8.

    BACKGROUND
  • Thomas SH, Blumen I. Helicopter Emergency Medical Services Literature 2014 to 2016: Lessons and Perspectives, Part 1-Helicopter Transport for Trauma. Air Med J. 2018 Jan-Feb;37(1):54-63. doi: 10.1016/j.amj.2017.10.006. Epub 2017 Dec 6. No abstract available.

    PMID: 29332779BACKGROUND
  • Thomas SH, Blumen I. Helicopter Emergency Medical Services Literature 2014 to 2016: Lessons and Perspectives, Part 2-Nontrauma Transports and General Issues. Air Med J. 2018 Mar-Apr;37(2):126-130. doi: 10.1016/j.amj.2017.10.005. Epub 2017 Dec 6. No abstract available.

    PMID: 29478578BACKGROUND
  • Ringburg AN, de Ronde G, Thomas SH, van Lieshout EM, Patka P, Schipper IB. Validity of helicopter emergency medical services dispatch criteria for traumatic injuries: a systematic review. Prehosp Emerg Care. 2009 Jan-Mar;13(1):28-36. doi: 10.1080/10903120802472012.

    PMID: 19145521BACKGROUND
  • Fevang E, Lockey D, Thompson J, Lossius HM; Torpo Research Collaboration. The top five research priorities in physician-provided pre-hospital critical care: a consensus report from a European research collaboration. Scand J Trauma Resusc Emerg Med. 2011 Oct 13;19:57. doi: 10.1186/1757-7241-19-57.

    PMID: 21996444BACKGROUND
  • Galvagno SM Jr, Sikorski R, Hirshon JM, Floccare D, Stephens C, Beecher D, Thomas S. Helicopter emergency medical services for adults with major trauma. Cochrane Database Syst Rev. 2015 Dec 15;2015(12):CD009228. doi: 10.1002/14651858.CD009228.pub3.

    PMID: 26671262BACKGROUND
  • Scholten AC, Haagsma JA, Panneman MJ, van Beeck EF, Polinder S. Traumatic brain injury in the Netherlands: incidence, costs and disability-adjusted life years. PLoS One. 2014 Oct 24;9(10):e110905. doi: 10.1371/journal.pone.0110905. eCollection 2014.

    PMID: 25343447BACKGROUND
  • Doucet J, Bulger E, Sanddal N, Fallat M, Bromberg W, Gestring M; Emergency Medical System Subcommittee, Committee on Trauma, American College of Surgeons. Appropriate use of helicopter emergency medical services for transport of trauma patients: guidelines from the Emergency Medical System Subcommittee, Committee on Trauma, American College of Surgeons. J Trauma Acute Care Surg. 2013 Oct;75(4):734-41. doi: 10.1097/TA.0b013e3182a5389e. No abstract available.

    PMID: 24064891BACKGROUND
  • Rathore SS, Curtis JP, Chen J, Wang Y, Nallamothu BK, Epstein AJ, Krumholz HM; National Cardiovascular Data Registry. Association of door-to-balloon time and mortality in patients admitted to hospital with ST elevation myocardial infarction: national cohort study. BMJ. 2009 May 19;338:b1807. doi: 10.1136/bmj.b1807.

    PMID: 19454739BACKGROUND
  • Pinto DS, Kirtane AJ, Nallamothu BK, Murphy SA, Cohen DJ, Laham RJ, Cutlip DE, Bates ER, Frederick PD, Miller DP, Carrozza JP Jr, Antman EM, Cannon CP, Gibson CM. Hospital delays in reperfusion for ST-elevation myocardial infarction: implications when selecting a reperfusion strategy. Circulation. 2006 Nov 7;114(19):2019-25. doi: 10.1161/CIRCULATIONAHA.106.638353. Epub 2006 Oct 30.

    PMID: 17075010BACKGROUND

Related Links

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • David Summermatter, RN

    Dalarna County Coucil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2019

First Posted

May 7, 2019

Study Start

September 3, 2019

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations