Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)

• 30 days mortality after injury or illness. [ Time Frame: 30 days after illness or injury ] [ Designated as safety issue: Yes ]
  Dead or alive
• Neurologic outcome at 6 months after injury or illness. [ Time Frame: 6 months after illness or injury ] [ Designated as safety issue: Yes ]
  Neurologic outcome will be assessed using glascow outcome scores (GOS-E)

• Intubation success rates and airway management complications for the entire cohort and for key subsets [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
• Length of hospital stay, complications and degree of disability at discharge. [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
• Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax). [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]

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.

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.

• Trauma
• Craniocerebral Trauma
• Intracerebral Hemorrhage
• Seizures
• Unconsciousness

• Procedure: Early Intubation
• Procedure: Late intubation

• Active Comparator: 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, an airway rescue device (e.g. supraglottic airway device), or surgical airway if required.
  Intervention: Procedure: Early Intubation
• Active Comparator: 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 commence first on arrival in the emergency department.
  Intervention: Procedure: Late intubation

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.

In addition, the investigators have specified a number of conditions that may require rapid endotracheal intubation or other lifesaving interventions on-scene or during transport that may necessitate deviation from study randomization.