Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.

Conditions
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Unconsciousness, Trauma, Craniocerebral Trauma, Intracerebral Hemorrhage, Seizures

Intervention / Treatment
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* Procedure: Early Intubation
* Procedure: Late intubation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Intubation<br>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<br> <br> |
| Active Comparator: Late intubation<br>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<br> <br> |

What is the study measuring?
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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 | Measure Description | 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 |