<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01730001</url>
  </required_header>
  <id_info>
    <org_study_id>NLA-3104-03/04</org_study_id>
    <nct_id>NCT01730001</nct_id>
  </id_info>
  <brief_title>Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services</brief_title>
  <acronym>ELITE</acronym>
  <official_title>A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS &lt; 9 and Short Transport Time to Hospital.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Air Ambulance Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian Air Ambulance Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study looks at advanced airway management in critically ill or injured patients treated&#xD;
      by physician manned emergency medical services, comparing early (on-scene) intubation to late&#xD;
      (emergency department) intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ELITE trial is a prospective randomized controlled trial (RCT) to compare competent&#xD;
      EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) &lt; 9&#xD;
      and short ambulance transport times (&lt; 20 min) to hospital.&#xD;
&#xD;
      The study aims to establish if advanced airway management with endotracheal intubation (ETI)&#xD;
      in the field by specially trained Emergency Medical Services (EMS) physicians - compared to&#xD;
      endotracheal intubation (ETI) performed by physicians in the emergency department in the same&#xD;
      group - improves outcome in terms of 30-day mortality, degree of disability at discharge,&#xD;
      complications and length of hospital stay, and neurologic outcome at 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn, no patients included&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2015</start_date>
  <completion_date type="Actual">March 28, 2017</completion_date>
  <primary_completion_date type="Actual">March 28, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30 days mortality after injury or illness.</measure>
    <time_frame>30 days after illness or injury</time_frame>
    <description>Dead or alive</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurologic outcome at 6 months after injury or illness.</measure>
    <time_frame>6 months after illness or injury</time_frame>
    <description>Neurologic outcome will be assessed using glascow outcome scores (GOS-E)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intubation success rates and airway management complications for the entire cohort and for key subsets</measure>
    <time_frame>up to 6 months after illness or injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay, complications and degree of disability at discharge.</measure>
    <time_frame>up to 6 months after illness or injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax).</measure>
    <time_frame>up to 6 months after illness or injury</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Trauma</condition>
  <condition>Craniocerebral Trauma</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Seizures</condition>
  <condition>Unconsciousness</condition>
  <arm_group>
    <arm_group_label>Early Intubation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late intubation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Late intubation is defined as on-scene prehospital high-flow (&gt; 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early Intubation</intervention_name>
    <arm_group_label>Early Intubation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Late intubation</intervention_name>
    <arm_group_label>Late intubation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt; 18 years)&#xD;
&#xD;
          -  Initial GCS &lt; 9 independent of cause.&#xD;
&#xD;
          -  Intact airway reflexes and no impending airway obstruction.&#xD;
&#xD;
          -  Located &lt; 20 min ambulance transport time from nearest hospital emergency department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (under 18 years).&#xD;
&#xD;
          -  Primary cardiorespiratory arrest (of non-traumatic / medical cause).&#xD;
&#xD;
          -  Planned helicopter transport to hospital.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geir A Sunde, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian Air Ambulance Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen JM Sollid, MD, PhD, Ass.Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Norwegian Air Ambulance Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans M Lossius, MD, PhD, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian Air Ambulance Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Espen Fevang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian Air Ambulance Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwegian Air Ambulance Foundation</name>
      <address>
        <city>Drøbak</city>
        <zip>1441</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://www.norskluftambulanse.no</url>
    <description>Norwegian Air Ambulance Foundation</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Unconsciousness</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01730001
org study id: NLA-3104-03/04
nct id: NCT01730001
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 30 days mortality after injury or illness.
time frame: 30 days after illness or injury
description: Dead or alive
measure: Neurologic outcome at 6 months after injury or illness.
time frame: 6 months after illness or injury
description: Neurologic outcome will be assessed using glascow outcome scores (GOS-E)
measure: 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
measure: Length of hospital stay, complications and degree of disability at discharge.
time frame: up to 6 months after illness or injury
measure: 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
arm group label: Early Intubation
arm group type: Active Comparator
description: 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.
arm group label: Late intubation
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: Early Intubation
arm group label: Early Intubation
intervention type: Procedure
intervention name: Late intubation
arm group label: Late intubation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geir A Sunde, MD
role: Principal Investigator
affiliation: Norwegian Air Ambulance Foundation
last name: Stephen JM Sollid, MD, PhD, Ass.Prof
role: Study Chair
affiliation: Norwegian Air Ambulance Foundation
last name: Hans M Lossius, MD, PhD, Prof
role: Study Director
affiliation: Norwegian Air Ambulance Foundation
last name: Espen Fevang, MD
role: Principal Investigator
affiliation: Norwegian Air Ambulance Foundation
facility: 
facility: 
country: Norway
url: http://www.norskluftambulanse.no
description: Norwegian Air Ambulance Foundation
responsible party type: Sponsor
mesh term: Seizures
mesh term: Cerebral Hemorrhage
mesh term: Craniocerebral Trauma
mesh term: Unconsciousness
mesh term: Hemorrhage
mesh term: Wounds and Injuries