Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

Trauma Clinical Trial

— ELITE  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01730001
• Other study ID #: NLA-3104-03/04
• Status: Withdrawn
• Phase: N/A
• First received: November 10, 2012
• Last updated: September 18, 2017
• Start date: January 1, 2015
• Est. completion date: March 28, 2017

Study information

• Verified date: September 2017
• Source: Norwegian Air Ambulance Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 28, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Craniocerebral Trauma
• Hemorrhage
• Intracerebral Hemorrhage
• Seizures
• Trauma
• Unconsciousness
• Wounds and Injuries

Intervention

Procedure:
• Early Intubation

• Late intubation

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Norwegian Air Ambulance Foundation	Drøbak

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Air Ambulance Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 days mortality after injury or illness.	Dead or alive	30 days after illness or injury
Primary	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
Secondary	Intubation success rates and airway management complications for the entire cohort and for key subsets		up to 6 months after illness or injury
Secondary	Length of hospital stay, complications and degree of disability at discharge.		up to 6 months after illness or injury
Secondary	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

External Links

•   Norwegian Air Ambulance Foundation