<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/NCT01683526</url>
  </required_header>
  <id_info>
    <org_study_id>139-12</org_study_id>
    <nct_id>NCT01683526</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope</brief_title>
  <official_title>Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent&#xD;
      endotracheal intubation of critically-ill patients has not been well-described in the&#xD;
      literature. This study will answer whether using a VL will impact on the efficacy and safety&#xD;
      of intubation compared with a traditional direct laryngoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>First Pass Success Rate</measure>
    <time_frame>From begining of intubation to verification. Less then 5 minutes approximatly</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe Desaturation</measure>
    <time_frame>For 10 minutes post intubation</time_frame>
    <description>sat &lt;80%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>For 10 minutes post intubation</time_frame>
    <description>SBP&lt;70</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Arrest</measure>
    <time_frame>For 1 hour post intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of Intubation</measure>
    <time_frame>For 10 minutes post intubation</time_frame>
    <description>Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intubation will be done using direct laryngoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intubation will be done using video laryngoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct laryngoscopy</intervention_name>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <other_name>standard laryngoscope</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Video laryngoscopy (Glidescope)</intervention_name>
    <arm_group_label>Video laryngoscopy</arm_group_label>
    <other_name>Glidescope Video Laryngoscope</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing urgent endotracheal intubation by a pulmonary critical care&#xD;
             medicine physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Oxygen saturation &lt; 92% despite adequate mask ventilation&#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>Michael Silverberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Isreal Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>May 23, 2014</results_first_submitted>
  <results_first_submitted_qc>May 23, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 25, 2014</results_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urgent endotrachel intubation</keyword>
  <keyword>Direct laryngoscopy</keyword>
  <keyword>Video laryngoscopy</keyword>
  <keyword>Glidescope</keyword>
  <keyword>Critical Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Direct Laryngoscopy</title>
          <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
        </group>
        <group group_id="P2">
          <title>Video Laryngoscopy</title>
          <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Direct Laryngoscopy</title>
          <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
        </group>
        <group group_id="B2">
          <title>Video Laryngoscopy</title>
          <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="57"/>
            <count group_id="B3" value="117"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.6" spread="15.9"/>
                    <measurement group_id="B2" value="65.4" spread="14.0"/>
                    <measurement group_id="B3" value="67.4" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Pass Success Rate</title>
        <time_frame>From begining of intubation to verification. Less then 5 minutes approximatly</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
          </group>
        </group_list>
        <measure>
          <title>First Pass Success Rate</title>
          <units>percentage of first pass success</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Desaturation</title>
        <description>sat &lt;80%</description>
        <time_frame>For 10 minutes post intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Desaturation</title>
          <description>sat &lt;80%</description>
          <units>percentage of patients with desaturation</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypotension</title>
        <description>SBP&lt;70</description>
        <time_frame>For 10 minutes post intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
          </group>
        </group_list>
        <measure>
          <title>Hypotension</title>
          <description>SBP&lt;70</description>
          <units>percentage of hypotension</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Arrest</title>
        <time_frame>For 1 hour post intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Arrest</title>
          <units>percentage of cardiac arrest</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications of Intubation</title>
        <description>Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.</description>
        <time_frame>For 10 minutes post intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
          </group>
          <group group_id="O2">
            <title>Video Laryngoscopy</title>
            <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
          </group>
        </group_list>
        <measure>
          <title>Complications of Intubation</title>
          <description>Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.</description>
          <units>percentage of other complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Direct Laryngoscopy</title>
          <description>Intubation will be done using direct laryngoscopy&#xD;
Direct laryngoscopy</description>
        </group>
        <group group_id="E2">
          <title>Video Laryngoscopy</title>
          <description>Intubation will be done using video laryngoscopy&#xD;
Video laryngoscopy (Glidescope)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Silverberg</name_or_title>
      <organization>Beth Israel Medical center</organization>
      <phone>2124202377</phone>
      <email>msilverberg2@chpnet.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01683526
org study id: 139-12
nct id: NCT01683526
lead sponsor: 
has dmc: No
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent
      endotracheal intubation of critically-ill patients has not been well-described in the
      literature. This study will answer whether using a VL will impact on the efficacy and safety
      of intubation compared with a traditional direct laryngoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: First Pass Success Rate
time frame: From begining of intubation to verification. Less then 5 minutes approximatly
measure: Severe Desaturation
time frame: For 10 minutes post intubation
description: sat <80%
measure: Hypotension
time frame: For 10 minutes post intubation
description: SBP<70
measure: Cardiac Arrest
time frame: For 1 hour post intubation
measure: Complications of Intubation
time frame: For 10 minutes post intubation
description: Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.
arm group label: Direct laryngoscopy
arm group type: Active Comparator
description: Intubation will be done using direct laryngoscopy
arm group label: Video laryngoscopy
arm group type: Active Comparator
description: Intubation will be done using video laryngoscopy
intervention type: Procedure
intervention name: Direct laryngoscopy
arm group label: Direct laryngoscopy
other name: standard laryngoscope
intervention type: Device
intervention name: Video laryngoscopy (Glidescope)
arm group label: Video laryngoscopy
other name: Glidescope Video Laryngoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Silverberg, MD
role: Principal Investigator
affiliation: Beth Israel Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 