A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Trauma
- Sponsor
- Norwegian Air Ambulance Foundation
- Locations
- 2
- Primary Endpoint
- 30 days mortality after injury or illness.
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
30 days mortality after injury or illness.
Time Frame: 30 days after illness or injury
Dead or alive
Neurologic outcome at 6 months after injury or illness.
Time Frame: 6 months after illness or injury
Neurologic outcome will be assessed using glascow outcome scores (GOS-E)
Secondary Outcomes
- 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)