Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

Not Applicable

Withdrawn

• Conditions: Trauma; Craniocerebral Trauma; Unconsciousness; Intracerebral Hemorrhage; Seizures

• Registration Number: NCT01730001
• Lead Sponsor: Norwegian Air Ambulance Foundation

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-11-10
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-21
• Study Start: 2015-01-01
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (2)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Norwegian Air Ambulance Foundation; 🇳🇴 Drøbak, Norway