IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)
This study has been withdrawn prior to enrollment.
(Withdrawn, no patients included)
Sponsor:
Norwegian Air Ambulance Foundation
Information provided by (Responsible Party):
Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier:
NCT01730001
First received: November 10, 2012
Last updated: September 18, 2017
Last verified: September 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Trauma Craniocerebral Trauma Intracerebral Hemorrhage Seizures Unconsciousness | Procedure: Early Intubation Procedure: Late intubation |
| Study Type: | Interventional |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
COL4A1-related brain small-vessel disease
MedlinePlus related topics:
Emergency Medical Services
U.S. FDA Resources
Further study details as provided by Norwegian Air Ambulance Foundation:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 0 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730001
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730001
Locations
| Norway | |
| Haukeland University Hospital | |
| Bergen, Norway, 5021 | |
| Norwegian Air Ambulance Foundation | |
| Drøbak, Norway, 1441 | |
Sponsors and Collaborators
Norwegian Air Ambulance Foundation
Investigators
| 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 |
More Information
Additional Information:
| Responsible Party: | Norwegian Air Ambulance Foundation |
| ClinicalTrials.gov Identifier: | NCT01730001 History of Changes |
| Other Study ID Numbers: |
NLA-3104-03/04 |
| Study First Received: | November 10, 2012 |
| Last Updated: | September 18, 2017 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 21, 2017