<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/NCT01664234</url>
  </required_header>
  <id_info>
    <org_study_id>ECS 1178/2012</org_study_id>
    <nct_id>NCT01664234</nct_id>
  </id_info>
  <brief_title>Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.&#xD;
      Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,&#xD;
      trisomy 21, or similar congenital malformations. Patients with American Society of&#xD;
      Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital&#xD;
      heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy&#xD;
      with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by&#xD;
      a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.&#xD;
      Randomization (1:1) will be based on computer-generated codes with random block sizes and&#xD;
      stratified by hospital; allocation will be concealed and provided to clinicians via a secure&#xD;
      web site that will be accessed shortly before induction of anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 30, 2014</completion_date>
  <primary_completion_date type="Actual">December 30, 2014</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to oxygen saturation</measure>
    <time_frame>Day 1</time_frame>
    <description>The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mean oxygenation comparison</measure>
    <time_frame>Day 1</time_frame>
    <description>Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Infants</condition>
  <condition>Difficult Airway</condition>
  <arm_group>
    <arm_group_label>laryngoscopy with simultaneous insufflation of oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laryngoscopy without simultaneous oxygen insufflation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laryngoscopy with oxygen</intervention_name>
    <description>Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.</description>
    <arm_group_label>laryngoscopy with simultaneous insufflation of oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laryngoscopy without oxygen</intervention_name>
    <description>Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.</description>
    <arm_group_label>laryngoscopy without simultaneous oxygen insufflation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants (0-2) difficult airways&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  . Patients with American Society of Anesthesiologists physical status scores ≥3&#xD;
             congenital heart disease left-to-right shunting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga Plattner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medizinischen Universität Wien Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinischen Universität Wien</name>
      <address>
        <city>Vienna</city>
        <state>Borschkegasse</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Olga Plattner</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>infants with cleft palate</keyword>
  <keyword>Pierre Robin</keyword>
  <keyword>Treacher Collins</keyword>
  <keyword>trisomy 21</keyword>
  <!-- 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/NCT01664234
org study id: ECS 1178/2012
nct id: NCT01664234
lead sponsor: 
has dmc: No
Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study.
      Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins,
      trisomy 21, or similar congenital malformations. Patients with American Society of
      Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital
      heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy
      with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by
      a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
      Randomization (1:1) will be based on computer-generated codes with random block sizes and
      stratified by hospital; allocation will be concealed and provided to clinicians via a secure
      web site that will be accessed shortly before induction of anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: time to oxygen saturation
time frame: Day 1
description: The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.
measure: mean oxygenation comparison
time frame: Day 1
description: Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test
arm group label: laryngoscopy with simultaneous insufflation of oxygen
arm group type: Experimental
description: Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
arm group label: laryngoscopy without simultaneous oxygen insufflation
arm group type: Placebo Comparator
description: Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
intervention type: Other
intervention name: laryngoscopy with oxygen
description: Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
arm group label: laryngoscopy with simultaneous insufflation of oxygen
intervention type: Other
intervention name: laryngoscopy without oxygen
description: Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
arm group label: laryngoscopy without simultaneous oxygen insufflation
criteria: 
gender: All
minimum age: 1 Month
maximum age: 2 Years
healthy volunteers: No
last name: Olga Plattner, M.D.
role: Principal Investigator
affiliation: Medizinischen Universität Wien Vienna
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Olga Plattner
investigator title: M.D.