Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)
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| ClinicalTrials.gov Identifier: NCT01730001 |
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Recruitment Status
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Withdrawn
(Withdrawn, no patients included)
First Posted
: November 21, 2012
Last Update Posted
: September 19, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Trauma Craniocerebral Trauma Intracerebral Hemorrhage Seizures Unconsciousness | Procedure: Early Intubation Procedure: Late intubation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| 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. |
| Estimated Study Start Date : | January 1, 2015 |
| Actual Primary Completion Date : | March 28, 2017 |
| Actual Study Completion Date : | March 28, 2017 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: Early Intubation |
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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.
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Procedure: Late intubation |
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730001
| Norway | |
| 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 |
Additional Information:
| Responsible Party: | Norwegian Air Ambulance Foundation |
| ClinicalTrials.gov Identifier: | NCT01730001 History of Changes |
| Other Study ID Numbers: |
NLA-3104-03/04 |
| First Posted: | November 21, 2012 Key Record Dates |
| Last Update Posted: | September 19, 2017 |
| Last Verified: | September 2017 |
Additional relevant MeSH terms:
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Hemorrhage Wounds and Injuries Seizures Cerebral Hemorrhage Craniocerebral Trauma Unconsciousness Pathologic Processes Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Intracranial Hemorrhages Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Trauma, Nervous System Consciousness Disorders Neurobehavioral Manifestations |