<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/NCT01710891</url>
  </required_header>
  <id_info>
    <org_study_id>HSR 11-3338</org_study_id>
    <nct_id>NCT01710891</nct_id>
  </id_info>
  <brief_title>Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management</brief_title>
  <official_title>Laryngoscope Versus CMAC for Endotracheal Intubation in Patients Undergoing Emergent Airway Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hennepin Healthcare Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hennepin Healthcare Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard&#xD;
      laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be&#xD;
      randomized to have their first intubation attempt done using either standard laryngoscopy or&#xD;
      the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating&#xD;
      physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental Design and Methods:&#xD;
&#xD;
      This will be a prospective randomized controlled trial of intubation using the C-MAC video&#xD;
      laryngoscope versus standard laryngoscopy for patients requiring emergent intubation in the&#xD;
      Emergency Department.&#xD;
&#xD;
      Study Setting and Population:&#xD;
&#xD;
      This study will be performed at an urban county medical center with approximately 97,000&#xD;
      patient visits per year. Adult patients (age &gt;17) requiring intubation will be enrolled.&#xD;
&#xD;
      Study Protocol:&#xD;
&#xD;
      All ED patients who are unable to adequately breathe on their own requiring emergent&#xD;
      intubation for airway management will be screened for inclusion in the study. Identified&#xD;
      patients will be deemed eligible when the need for intubation has been determined by the&#xD;
      treating physician. Eligible patients will be placed on capnograph, cardiac, blood pressure&#xD;
      and pulse oximetry monitors. Patients will be randomly assigned to be intubated using&#xD;
      standard laryngoscopy with the C-MAC blade or C-MAC videolaryngoscope. Sealed envelopes&#xD;
      containing the randomization assignment for the treatment groups will be kept at the&#xD;
      patient's bedside in the stabilization room. Patients will be monitored by oxygen saturation,&#xD;
      blood pressure, heart rate, and respiratory rate, which are typical for patients requiring&#xD;
      intubation in our ED. Data will be recorded every minute by a trained research assistant at&#xD;
      the patient's bedside. The lowest oxygen saturation during the procedure will be recorded for&#xD;
      determination of hypoxia. Hypoxia will be defined as an oxygen saturation &lt;93%. The number of&#xD;
      attempts made to intubate and the total time to successful intubation will be recorded. An&#xD;
      attempt starts when the intubating device enters the patients mouth and ends when the&#xD;
      endotracheal tube placement is confirmed or when a new intubating device is put in the&#xD;
      patients mouth after the previous device had been removed. Data collection includes the&#xD;
      timing and number of breaths given via Bag-Valve-Mask and patient repositioning between the&#xD;
      attempts. All treatments will be recorded. Data collection will continue until the patient is&#xD;
      discharged from the Emergency Department. The patient's diagnosis at the time of discharge&#xD;
      from the ED will be recorded. Patients' charts will be reviewed to determine the diagnosis,&#xD;
      occurrence of aspiration pneumonia, ICU length of stay, and inpatient length of stay. Two&#xD;
      attempts will be made to contact patients 28 days after study enrollment to determine their&#xD;
      condition at that time.&#xD;
&#xD;
      Data Analysis:&#xD;
&#xD;
      Data will be collected by a designated research assistant during the procedure and will then&#xD;
      be entered into an EXCEL (Microsoft Corp., Redmond, WA) database for storage. Data will be&#xD;
      exported into STATA 10.0 (STATA Corp., College Station, TX) for further analysis. The number&#xD;
      of attempts to successful intubation and total time to intubation will be compared using&#xD;
      descriptive statistics. Occurrence of hypoxia and aspiration pneumonia will be compared in&#xD;
      patients who were intubated with the C-MAC to patients intubated with standard laryngoscopy&#xD;
      using Chi-Square tests. Oxygen saturation, ETCO2, and heart rate will be compared in both&#xD;
      groups using multiple linear regression.&#xD;
&#xD;
      The length of stay and 28 day follow up between the two groups will be compared using&#xD;
      Wilcoxon rank sum tests. In order to detect a 15% difference in the length of stay between&#xD;
      the two groups, with a power of 80% and an alpha of 0.05, 100 patients will be required in&#xD;
      each group for a total of 200 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 4</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 in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.</measure>
    <time_frame>During intubation procedure up to 1 hour</time_frame>
    <description>An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Intubation</measure>
    <time_frame>From the time the first device entered the patients mouth until successful intubation up to 1 hour</time_frame>
    <description>The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Stay</measure>
    <time_frame>From the time of hospital admission until discharge up to 28 days</time_frame>
    <description>The time in days from hospital admission until discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspiration Pneumonia</measure>
    <time_frame>from the time of hospital admission up to 28 days</time_frame>
    <description>The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Hypoxia</measure>
    <time_frame>From the start of the procedure until successful intubation up to 1 hour</time_frame>
    <description>Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failed Intubation</measure>
    <time_frame>from the start of the procedure until successful intubation up to one hour</time_frame>
    <description>Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Acute Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CMAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CMAC videolaryngoscope</intervention_name>
    <description>patients are intubated using the CMAC video laryngoscope</description>
    <arm_group_label>CMAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Laryngoscopy</intervention_name>
    <description>Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age &gt;17) requiring emergent endotracheal intubation in the Emergency&#xD;
             Department using direct laryngoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physician intends to intubate with a device other than a direct laryngoscope&#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>James R Miner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hennepin Healthcare Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>February 18, 2016</results_first_submitted>
  <results_first_submitted_qc>December 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2019</results_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endotracheal intubation</keyword>
  <keyword>direct laryngoscopy</keyword>
  <keyword>video laryngoscopy</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Direct Laryngoscopy</title>
          <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
        </group>
        <group group_id="P2">
          <title>CMAC</title>
          <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="103"/>
              </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>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
        </group>
        <group group_id="B2">
          <title>CMAC</title>
          <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</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="95"/>
            <count group_id="B2" value="103"/>
            <count group_id="B3" value="198"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.6" lower_limit="19" upper_limit="88"/>
                    <measurement group_id="B2" value="52.6" lower_limit="19" upper_limit="86"/>
                    <measurement group_id="B3" value="52.1" lower_limit="19" upper_limit="88"/>
                  </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="32"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.</title>
        <description>An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide</description>
        <time_frame>During intubation procedure up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.</title>
          <description>An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3" lower_limit="79.2" upper_limit="93.4"/>
                    <measurement group_id="O2" value="92.2" lower_limit="87.0" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Intubation</title>
        <description>The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation</description>
        <time_frame>From the time the first device entered the patients mouth until successful intubation up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Intubation</title>
          <description>The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation</description>
          <units>Seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" lower_limit="49" upper_limit="69"/>
                    <measurement group_id="O2" value="61" lower_limit="46" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay</title>
        <description>The time in days from hospital admission until discharge.</description>
        <time_frame>From the time of hospital admission until discharge up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay</title>
          <description>The time in days from hospital admission until discharge.</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" lower_limit="6.6" upper_limit="11.5"/>
                    <measurement group_id="O2" value="8.5" lower_limit="6.6" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aspiration Pneumonia</title>
        <description>The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure</description>
        <time_frame>from the time of hospital admission up to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Aspiration Pneumonia</title>
          <description>The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure</description>
          <units>Percentage of Aspiration Pneumonia</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="5.3" upper_limit="19.1"/>
                    <measurement group_id="O2" value="7.2" lower_limit="2.0" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Hypoxia</title>
        <description>Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia</description>
        <time_frame>From the start of the procedure until successful intubation up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Hypoxia</title>
          <description>Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia</description>
          <units>Percentage of Hypoxemia</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" lower_limit="18.4" upper_limit="36.3"/>
                    <measurement group_id="O2" value="25.2" lower_limit="16.9" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Failed Intubation</title>
        <description>Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.</description>
        <time_frame>from the start of the procedure until successful intubation up to one hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscopy</title>
            <description>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
          </group>
          <group group_id="O2">
            <title>CMAC</title>
            <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</description>
          </group>
        </group_list>
        <measure>
          <title>Failed Intubation</title>
          <description>Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5"/>
                    <measurement group_id="O2" value="25"/>
                  </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>Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.&#xD;
Direct Laryngoscopy: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.</description>
        </group>
        <group group_id="E2">
          <title>CMAC</title>
          <description>Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance&#xD;
CMAC videolaryngoscope: patients are intubated using the CMAC video laryngoscope</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="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </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="95"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Brian Driver</name_or_title>
      <organization>MinneapolisMRF</organization>
      <phone>6128739528</phone>
      <email>Brian.Driver@hcmed.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/NCT01710891
org study id: HSR 11-3338
nct id: NCT01710891
lead sponsor: 
has dmc: Yes
Randomized controlled trial of intubation using the C-MAC video laryngoscope versus standard
      laryngoscopy. Patients who are going to be intubated using standard laryngoscopy will be
      randomized to have their first intubation attempt done using either standard laryngoscopy or
      the C-MAC video laryngoscope. Subsequent attempts will be at the discretion of the treating
      physician.
Experimental Design and Methods:

      This will be a prospective randomized controlled trial of intubation using the C-MAC video
      laryngoscope versus standard laryngoscopy for patients requiring emergent intubation in the
      Emergency Department.

      Study Setting and Population:

      This study will be performed at an urban county medical center with approximately 97,000
      patient visits per year. Adult patients (age >17) requiring intubation will be enrolled.

      Study Protocol:

      All ED patients who are unable to adequately breathe on their own requiring emergent
      intubation for airway management will be screened for inclusion in the study. Identified
      patients will be deemed eligible when the need for intubation has been determined by the
      treating physician. Eligible patients will be placed on capnograph, cardiac, blood pressure
      and pulse oximetry monitors. Patients will be randomly assigned to be intubated using
      standard laryngoscopy with the C-MAC blade or C-MAC videolaryngoscope. Sealed envelopes
      containing the randomization assignment for the treatment groups will be kept at the
      patient's bedside in the stabilization room. Patients will be monitored by oxygen saturation,
      blood pressure, heart rate, and respiratory rate, which are typical for patients requiring
      intubation in our ED. Data will be recorded every minute by a trained research assistant at
      the patient's bedside. The lowest oxygen saturation during the procedure will be recorded for
      determination of hypoxia. Hypoxia will be defined as an oxygen saturation <93%. The number of
      attempts made to intubate and the total time to successful intubation will be recorded. An
      attempt starts when the intubating device enters the patients mouth and ends when the
      endotracheal tube placement is confirmed or when a new intubating device is put in the
      patients mouth after the previous device had been removed. Data collection includes the
      timing and number of breaths given via Bag-Valve-Mask and patient repositioning between the
      attempts. All treatments will be recorded. Data collection will continue until the patient is
      discharged from the Emergency Department. The patient's diagnosis at the time of discharge
      from the ED will be recorded. Patients' charts will be reviewed to determine the diagnosis,
      occurrence of aspiration pneumonia, ICU length of stay, and inpatient length of stay. Two
      attempts will be made to contact patients 28 days after study enrollment to determine their
      condition at that time.

      Data Analysis:

      Data will be collected by a designated research assistant during the procedure and will then
      be entered into an EXCEL (Microsoft Corp., Redmond, WA) database for storage. Data will be
      exported into STATA 10.0 (STATA Corp., College Station, TX) for further analysis. The number
      of attempts to successful intubation and total time to intubation will be compared using
      descriptive statistics. Occurrence of hypoxia and aspiration pneumonia will be compared in
      patients who were intubated with the C-MAC to patients intubated with standard laryngoscopy
      using Chi-Square tests. Oxygen saturation, ETCO2, and heart rate will be compared in both
      groups using multiple linear regression.

      The length of stay and 28 day follow up between the two groups will be compared using
      Wilcoxon rank sum tests. In order to detect a 15% difference in the length of stay between
      the two groups, with a power of 80% and an alpha of 0.05, 100 patients will be required in
      each group for a total of 200 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.
time frame: During intubation procedure up to 1 hour
description: An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide
measure: Time to Intubation
time frame: From the time the first device entered the patients mouth until successful intubation up to 1 hour
description: The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation
measure: Length of Stay
time frame: From the time of hospital admission until discharge up to 28 days
description: The time in days from hospital admission until discharge.
measure: Aspiration Pneumonia
time frame: from the time of hospital admission up to 28 days
description: The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure
measure: Incidence of Hypoxia
time frame: From the start of the procedure until successful intubation up to 1 hour
description: Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia
measure: Failed Intubation
time frame: from the start of the procedure until successful intubation up to one hour
description: Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.
arm group label: Direct Laryngoscopy
arm group type: Active Comparator
description: Patients will undergo their first intubation attempt with direct laryngoscopy using the CMAC device without video assistance. The video monitor with be covered with a hood.
arm group label: CMAC
arm group type: Experimental
description: Patients will undergo their first intubation attempt using the CMAC videolaryngoscope using video assistance
intervention type: Procedure
intervention name: CMAC videolaryngoscope
description: patients are intubated using the CMAC video laryngoscope
arm group label: CMAC
intervention type: Procedure
intervention name: Direct Laryngoscopy
description: Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.
arm group label: Direct Laryngoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James R Miner, MD
role: Principal Investigator
affiliation: Hennepin Healthcare Research Institute
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 