TraumaELITENCT01730001
Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services
A study testing Early Intubation and Late intubation in people with Trauma and Craniocerebral Trauma, run by Norwegian Air Ambulance Foundation at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Craniocerebral Trauma, Intracerebral Hemorrhage
- What is being tested?
- Early Intubation and Late intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2015to 28 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pediatric patients (under 18 years).
- Primary cardiorespiratory arrest (of non-traumatic / medical cause).
- Planned helicopter transport to hospital.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Norwegian Air Ambulance Foundation
Drøbak, 1441
About this study
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.
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.
Read the 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.
- Being tested
- Early Intubation, Late intubation
- Medical subject headings
- Wounds and Injuries, Craniocerebral Trauma, Cerebral Hemorrhage, Seizures, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early IntubationProcedure or surgery
Late intubationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early Intubation |
| 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. Receives: Procedure: Late intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days mortality after injury or illness.
Dead or alive
Measured: 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)
Measured: 6 months after illness or injury
Secondary outcomes (3)
Intubation success rates and airway management complications for the entire cohort and for key subsets
Measured: up to 6 months after illness or injury
Length of hospital stay, complications and degree of disability at discharge.
Measured: 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).
Measured: up to 6 months after illness or injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start1 Jan 2015 (estimated)
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Why it stopped: Withdrawn, no patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Air Ambulance Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geir A Sunde, MD, Principal investigator, Norwegian Air Ambulance FoundationStephen JM Sollid, MD, PhD, Ass.Prof, Study chair, Norwegian Air Ambulance FoundationHans M Lossius, MD, PhD, Prof, Study director, Norwegian Air Ambulance FoundationEspen Fevang, MD, Principal investigator, Norwegian Air Ambulance Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730001
- Sponsor's protocol ID
- NLA-3104-03/04
- Acronym
- ELITE
- Status last verified
- Sep 2017
- First submitted
- 10 Nov 2012
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01730001
- Acronym / sponsor ID
- ELITE / NLA-3104-03/04
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn, no patients included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian Air Ambulance FoundationUniversity, hospital or other
- Study start
- 1 Jan 2015 (estimated)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intubation | Active comparator | Procedure: Early IntubationEarly 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 | Procedure: Late intubationLate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Pediatric patients (under 18 years).
- Primary cardiorespiratory arrest (of non-traumatic / medical cause).
- Planned helicopter transport to hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Intubation | Procedure or surgery | Early Intubation |
| Late intubation | Procedure or surgery | Late intubation |
Primary outcome
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)
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Norwegian Air Ambulance FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir A Sunde, MD principal investigator
Norwegian Air Ambulance Foundation
Stephen JM Sollid, MD, PhD, Ass.Prof study chair
Norwegian Air Ambulance Foundation
Hans M Lossius, MD, PhD, Prof study director
Norwegian Air Ambulance Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intubation and Late intubation in people with Trauma and Craniocerebral Trauma, run by Norwegian Air Ambulance Foundation at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 days mortality after injury or illness. (time frame: 30 days after illness or injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.