Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)
|Trauma Craniocerebral Trauma Intracerebral Hemorrhage Seizures Unconsciousness||Procedure: Early Intubation Procedure: Late intubation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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.|
- 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)
- 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 ]
- Length of hospital stay, complications and degree of disability at discharge. [ Time Frame: 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). [ Time Frame: up to 6 months after illness or injury ]
|Anticipated Study Start Date:||January 1, 2015|
|Study Completion Date:||March 28, 2017|
|Primary Completion Date:||March 28, 2017 (Final data collection date for primary outcome measure)|
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.
|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 be done on arrival in the emergency department.
|Procedure: Late 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730001
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Norwegian Air Ambulance Foundation|
|Drøbak, Norway, 1441|
|Principal Investigator:||Geir A Sunde, MD||Norwegian Air Ambulance Foundation|
|Study Chair:||Stephen JM Sollid, MD, PhD, Ass.Prof||Norwegian Air Ambulance Foundation|
|Study Director:||Hans M Lossius, MD, PhD, Prof||Norwegian Air Ambulance Foundation|
|Principal Investigator:||Espen Fevang, MD||Norwegian Air Ambulance Foundation|