Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

Not Applicable

Withdrawn

• Conditions: Trauma; Craniocerebral Trauma; Unconsciousness; Intracerebral Hemorrhage; Seizures
• Interventions: Procedure: Late intubation; Procedure: Early Intubation

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Late intubation	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.
Early Intubation	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.

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