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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This study has been withdrawn prior to enrollment.
(Withdrawn, no patients included)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
  Purpose
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.

Condition Intervention
Trauma Craniocerebral Trauma Intracerebral Hemorrhage Seizures Unconsciousness Procedure: Early Intubation Procedure: Late intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.

Resource links provided by NLM:


Further study details as provided by Norwegian Air Ambulance Foundation:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Anticipated Study Start Date: January 1, 2015
Study Completion Date: March 28, 2017
Primary Completion Date: March 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Procedure: Late intubation

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730001


Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Norwegian Air Ambulance Foundation
Drøbak, Norway, 1441
Sponsors and Collaborators
Norwegian Air Ambulance Foundation
Investigators
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
  More Information

Additional Information:
Responsible Party: Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier: NCT01730001     History of Changes
Other Study ID Numbers: NLA-3104-03/04
First Submitted: November 10, 2012
First Posted: November 21, 2012
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hemorrhage
Wounds and Injuries
Seizures
Cerebral Hemorrhage
Craniocerebral Trauma
Unconsciousness
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Trauma, Nervous System
Consciousness Disorders
Neurobehavioral Manifestations