Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)

This study has suspended participant recruitment.
(Change in study protocol, needs new ethical consideration.)
Sponsor:
Information provided by (Responsible Party):
Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier:
NCT01730001
First received: November 10, 2012
Last updated: October 25, 2013
Last verified: October 2013

November 10, 2012
October 25, 2013
September 2013
December 2015   (final data collection date for primary outcome measure)
  • 30 days mortality after injury or illness. [ Time Frame: 30 days after illness or injury ] [ Designated as safety issue: Yes ]
    Dead or alive
  • Neurologic outcome at 6 months after injury or illness. [ Time Frame: 6 months after illness or injury ] [ Designated as safety issue: Yes ]
    Neurologic outcome will be assessed using glascow outcome scores (GOS-E)
Same as current
Complete list of historical versions of study NCT01730001 on ClinicalTrials.gov Archive Site
  • Intubation success rates and airway management complications for the entire cohort and for key subsets [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
  • Length of hospital stay, complications and degree of disability at discharge. [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
  • Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax). [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services
A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.

This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

The ELITE trial is a prospective randomized controlled trial (RCT) to compare competent EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) < 9 and short ambulance transport times (< 20 min) to hospital.

The study aims to establish if advanced airway management with endotracheal intubation (ETI) in the field by specially trained Emergency Medical Services (EMS) physicians - compared to endotracheal intubation (ETI) performed by physicians in the emergency department in the same group - improves outcome in terms of 30-day mortality, degree of disability at discharge, complications and length of hospital stay, and neurologic outcome at 6 months.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Trauma
  • Craniocerebral Trauma
  • Intracerebral Hemorrhage
  • Seizures
  • Unconsciousness
  • Procedure: Early Intubation
  • Procedure: Late intubation
  • Active Comparator: Early Intubation
    Early intubation is defined as prehospital intubation on the scene of the patient illness/injury, or where the EMS physician first meets the patient (e.g en route to hospital). Intubation includes drug assisted and/or rapid sequence intubation (RSI) with endotracheal tube.
    Intervention: Procedure: Early Intubation
  • Active Comparator: Late intubation
    Late intubation is defined as on-scene prehospital high-flow (> 10 L/min) supplemental oxygen by mask, assisted bag-mask-ventilation by EMS physician if required and stable recovery position during transport to hospital. Intubation should be done on arrival in the emergency department.
    Intervention: Procedure: Late intubation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
500
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (> 18 years)
  • Initial GCS < 9 independent of cause.
  • Intact airway reflexes and no impending airway obstruction.
  • Located < 20 min ambulance transport time from nearest hospital emergency department.

Exclusion Criteria:

  • Pediatric patients (under 18 years).
  • Primary cardiorespiratory arrest (of non-traumatic / medical cause).
  • Planned helicopter transport to hospital.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01730001
NLA-3104-03/04
Yes
Norwegian Air Ambulance Foundation
Norwegian Air Ambulance Foundation
Not Provided
Principal Investigator: Geir A Sunde, MD Norwegian Air Ambulance Foundation
Study Chair: Stephen JM Sollid, MD, PhD, Ass.Prof Norwegian Air Ambulance Foundation
Study Director: Hans M Lossius, MD, PhD, Prof Norwegian Air Ambulance Foundation
Principal Investigator: Espen Fevang, MD Norwegian Air Ambulance Foundation
Norwegian Air Ambulance Foundation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP