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

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.

Study Overview

• Status: Withdrawn
• Conditions: Craniocerebral Trauma; Trauma; Seizures; Unconsciousness; Intracerebral Hemorrhage
• Intervention / Treatment: Procedure: Early Intubation; 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Drøbak, Norway, 1441
    • Norwegian Air Ambulance Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 days mortality after injury or illness.	Dead or alive	30 days after illness or injury
Neurologic outcome at 6 months after injury or illness.	Neurologic outcome will be assessed using glascow outcome scores (GOS-E)	6 months after illness or injury

Secondary Outcome Measures

Outcome Measure	Time Frame
Intubation success rates and airway management complications for the entire cohort and for key subsets	up to 6 months after illness or injury
Length of hospital stay, complications and degree of disability at discharge.	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).	up to 6 months after illness or injury

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Norwegian Air Ambulance Foundation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2015
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): March 28, 2017

Study Registration Dates

• First Submitted: November 10, 2012
• First Submitted That Met QC Criteria: November 14, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Trauma, Nervous System; Consciousness Disorders; Intracranial Hemorrhages; Wounds and Injuries; Hemorrhage; Seizures; Cerebral Hemorrhage; Unconsciousness; Craniocerebral Trauma
• Other Study ID Numbers: NLA-3104-03/04