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

This study has been withdrawn prior to enrollment.
(Withdrawn, no patients included)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730001
First Posted: November 21, 2012
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian Air Ambulance Foundation
November 10, 2012
November 21, 2012
September 19, 2017
January 1, 2015
March 28, 2017   (Final data collection date for primary outcome measure)
  • 30 days mortality after injury or illness. [ Time Frame: 30 days after illness or injury ]
    Dead or alive
  • Neurologic outcome at 6 months after injury or illness. [ Time Frame: 6 months after illness or injury ]
    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 ]
  • Length of hospital stay, complications and degree of disability at discharge. [ Time Frame: up to 6 months after illness or injury ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Withdrawn
0
March 28, 2017
March 28, 2017   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01730001
NLA-3104-03/04
Yes
Not Provided
Not Provided
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
September 2017

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