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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intubation | Active Comparator | 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. |
|
| Late intubation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Intubation | Procedure |
| ||
| Late intubation |
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality after injury or illness. | Dead or alive | 30 days after illness or injury |
| Neurologic outcome at 6 months after injury or illness. | Neurologic outcome will be assessed using glascow outcome scores (GOS-E) | 6 months after illness or injury |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geir A Sunde, MD | Norwegian Air Ambulance Foundation | Principal Investigator |
| Stephen JM Sollid, MD, PhD, Ass.Prof | Norwegian Air Ambulance Foundation | Study Chair |
| Hans M Lossius, MD, PhD, Prof | Norwegian Air Ambulance Foundation | Study Director |
| Espen Fevang, MD | Norwegian Air Ambulance Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5021 | Norway | |||
| Norwegian Air Ambulance Foundation |
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| Label | URL |
|---|---|
| Norwegian Air Ambulance Foundation | View source |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006259 | Craniocerebral Trauma |
| D002543 | Cerebral Hemorrhage |
| D012640 | Seizures |
| D014474 | Unconsciousness |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| 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 |
| Drøbak |
| 1441 |
| Norway |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |