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Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

NCT ID: NCT01730001

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-03-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Trauma Craniocerebral Trauma Intracerebral Hemorrhage Seizures Unconsciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Early Intubation

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Late intubation

Intervention Type PROCEDURE

Interventions

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Early Intubation

Intervention Type PROCEDURE

Late intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Air Ambulance Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geir A Sunde, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Air Ambulance Foundation

Stephen JM Sollid, MD, PhD, Ass.Prof

Role: STUDY_CHAIR

Norwegian Air Ambulance Foundation

Hans M Lossius, MD, PhD, Prof

Role: STUDY_DIRECTOR

Norwegian Air Ambulance Foundation

Espen Fevang, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Air Ambulance Foundation

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status

Norwegian Air Ambulance Foundation

Drøbak, , Norway

Site Status

Countries

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Norway

Related Links

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http://www.norskluftambulanse.no

Norwegian Air Ambulance Foundation

Other Identifiers

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NLA-3104-03/04

Identifier Type: -

Identifier Source: org_study_id