Clinical trial NCT01730001: Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services
Official title: A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma
Craniocerebral Trauma
Intracerebral Hemorrhage
Seizures
Unconsciousness
Lead sponsor: Norwegian Air Ambulance Foundation
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 30 days mortality after injury or illness.
timeFrame: 30 days after illness or injury
measure: Neurologic outcome at 6 months after injury or illness.
timeFrame: 6 months after illness or injury
Secondary outcomes:
measure: Intubation success rates and airway management complications for the entire cohort and for key subsets
timeFrame: up to 6 months after illness or injury
measure: Length of hospital stay, complications and degree of disability at discharge.
timeFrame: up to 6 months after illness or injury
measure: Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax).
timeFrame: up to 6 months after illness or injury
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drøbak
country: Norway
facility: Norwegian Air Ambulance Foundation
Study officials:
affiliation: Norwegian Air Ambulance Foundation
name: Geir A Sunde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Air Ambulance Foundation
name: Stephen JM Sollid, MD, PhD, Ass.Prof
role: STUDY_CHAIR
affiliation: Norwegian Air Ambulance Foundation
name: Hans M Lossius, MD, PhD, Prof
role: STUDY_DIRECTOR
affiliation: Norwegian Air Ambulance Foundation
name: Espen Fevang, MD
role: PRINCIPAL_INVESTIGATOR
References: