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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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)


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 ] [ 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 ]

Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier: NCT01730001     History of Changes
Other Study ID Numbers: NLA-3104-03/04
Study First Received: November 10, 2012
Last Updated: October 25, 2013
Health Authority: Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on July 31, 2014