Craniocerebral Trauma, Intracerebral Hemorrhage, Seizures, Trauma, Unconsciousness
Conditions
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.
Interventions
PROCEDUREEarly Intubation
PROCEDURELate intubation
Sponsors
Norwegian Air Ambulance Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
Norway
Outcome results
None listed