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

Norwegian Air Ambulance Foundation

Status: Withdrawn

Conditions: Unconsciousness; Seizures; Trauma; Intracerebral Hemorrhage; Craniocerebral Trauma

Treatments: Procedure: Late intubation; Procedure: Early Intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01730001

NLA-3104-03/04

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early Intubation

Active Comparator group

Description:

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.

Treatment:

Procedure: Early Intubation

Late intubation

Active Comparator group

Description:

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.

Treatment:

Procedure: Late intubation