<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/NCT01717872</url>
  </required_header>
  <id_info>
    <org_study_id>Lerman Blade study</org_study_id>
    <nct_id>NCT01717872</nct_id>
  </id_info>
  <brief_title>Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age</brief_title>
  <official_title>Comparing the Laryngoscopy View Using Miller and Macintosh Laryngoscopy Blades in Infants Under Two Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the laryngoscopy view using two standard clinical devices, the Macintosh and&#xD;
      Miller laryngoscopy blades, in infants between one day and two years of age.&#xD;
&#xD;
      Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in&#xD;
      pediatric clinical practice in some institutions especially in infants. The anatomy of infant&#xD;
      airway has traditionally been considered to lend itself to advantages of the Miller blade.&#xD;
      Some argue that the Miller blade offers a superior view of the laryngeal inlet because it&#xD;
      lifts the epiglottis. However, others use the Miller blade to expose the larynx without&#xD;
      lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of&#xD;
      these blades, more than 50 years, no systematic study has ever compared the laryngoscopy&#xD;
      views of the Miller and Macintosh blades in infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  After Institutional Review Board approval, the patients meeting inclusion criteria will&#xD;
           be selected from the Operating room elective surgical list.&#xD;
&#xD;
        -  They will be randomized to one of the two groups: a #1 Miller or Macintosh blade.&#xD;
&#xD;
        -  After obtaining informed consent from the parent or the legal guardian, monitors&#xD;
           (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter) that are&#xD;
           routine induction of anesthesia will be applied and anesthesia will be induced using an&#xD;
           inhalation technique with sevoflurane, nitrous oxide and oxygen. An intravenous cannula&#xD;
           will then be placed. The child will then receive a standard intubating dose of a muscle&#xD;
           relaxant (rocuronium 0.5-1 mg/kg). The lungs will be mask ventilated using 100% oxygen&#xD;
           in Sevoflurane for 3 minutes to allow appropriate time for the muscle relaxant to be&#xD;
           fully effective. At that time, the randomized code for that child will be opened and&#xD;
           laryngoscopy will be performed with either a Miller or MacIntosh blade as indicated by&#xD;
           the code.&#xD;
&#xD;
        -  The best possible glottic view will be obtained by ensuring the following steps. The&#xD;
           child's head will be positioned in the Magill position, muscle relaxant will be&#xD;
           administered, firm forward traction will be applied to the laryngoscope handle, and if&#xD;
           needed, external laryngeal manipulation will be applied.&#xD;
&#xD;
        -  During the same laryngoscopy, the best glottic visualization will be obtained with the&#xD;
           blade lifting the epiglottis and not lifting the epiglottis, in random order (by&#xD;
           flipping a coin). This difference is a matter of moving the position of the blade back&#xD;
           without removing the blade from the larynx.&#xD;
&#xD;
        -  The two views will be recorded by a second doctor using a SONY camera at the mouth&#xD;
           adjacent to the laryngoscope handle.&#xD;
&#xD;
        -  Photos of the glottic opening will be graded using the POGO scale (Ref1) by a third&#xD;
           (blinded) anesthesiologist.&#xD;
&#xD;
        -  All of the intubations and image acquisition will be performed by Drs. Yuvesh Passi,&#xD;
           Jerrold Lerman or Chris Heard.&#xD;
&#xD;
        -  The images obtained will not have patient identifiers included. They will be stored in a&#xD;
           secure file once the study is completed that will be accessed only by investigators&#xD;
           involved in the study.&#xD;
&#xD;
        -  No patient identifiers will be included on any documentation apart from the source&#xD;
           documents.&#xD;
&#xD;
        -  The research data will be stored in a locked office of Dr. Lerman (Room 251) in&#xD;
           Department of Anesthesia, Women and Children's Hospital of Buffalo during and after the&#xD;
           study for security to protect subject privacy and confidentiality.&#xD;
&#xD;
        -  There will be no payments or compensation to the study subjects&#xD;
&#xD;
      The primary hypothesis of this study is to compare the view of the larynx with Miller blade&#xD;
      while lifting the epiglottis to the Macintosh blade lifting the tongue, in infants and&#xD;
      children &lt;2 years of age. However, views will be obtained with the Miller and Macintosh&#xD;
      blades both lifting and not lifting the epiglottis and comparisons between pairs of&#xD;
      measurements will be performed. In order for to detect superiority of one technique over the&#xD;
      other, we will need a difference in the POGO scores of 25 points with a standard deviation of&#xD;
      25 points, yielding a sample size of 15 children in each group. To account for photographic&#xD;
      difficulties, unreadable photos as well as dropouts, we will enroll 25 children in each&#xD;
      group. Therefore a total of 50 children will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).</measure>
    <time_frame>30 seconds</time_frame>
    <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue</measure>
    <time_frame>30 seconds</time_frame>
    <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis</measure>
    <time_frame>30 seconds</time_frame>
    <description>The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Percent of Glottic Opening</condition>
  <arm_group>
    <arm_group_label>Macintosh laryngoscope blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the Percent of Glottic Opening (POGO) score by a blinded assessor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miller laryngoscope blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the percent of glottic opening score by a blinded assessor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngoscope blade</intervention_name>
    <description>The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis</description>
    <arm_group_label>Macintosh laryngoscope blade</arm_group_label>
    <arm_group_label>Miller laryngoscope blade</arm_group_label>
    <other_name>Macintosh laryngoscope blade</other_name>
    <other_name>Miller laryngoscope blade</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American society of anesthesiologists physical status 1 and 2 infants and children&#xD;
&#xD;
          -  Age &lt;2 years of age&#xD;
&#xD;
          -  All racial and ethnic origin&#xD;
&#xD;
          -  Scheduled for elective surgery&#xD;
&#xD;
          -  Fasting patients who are unmedicated preoperatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of difficult airway&#xD;
&#xD;
          -  Severe asthma&#xD;
&#xD;
          -  Premature birth&#xD;
&#xD;
          -  ICU stay for more than a week following delivery&#xD;
&#xD;
          -  Acute or chronic pulmonary or neuromuscular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerrold Lerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SUNY at Buffalo, Women and Children's Hospital of Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women and Childrens Hospital of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>August 8, 2014</results_first_submitted>
  <results_first_submitted_qc>March 24, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 11, 2016</results_first_posted>
  <last_update_submitted>February 10, 2017</last_update_submitted>
  <last_update_submitted_qc>February 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Jerrold Lerman</investigator_full_name>
    <investigator_title>Clinical Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>glottis, laryngoscopy, laryngoscope blade</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyrithione zinc</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Macintosh Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
        </group>
        <group group_id="P2">
          <title>Miller Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </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>Macintosh Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
        </group>
        <group group_id="B2">
          <title>Miller Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</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="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15" lower_limit="4" upper_limit="23"/>
                    <measurement group_id="B2" value="14" lower_limit="5" upper_limit="23"/>
                    <measurement group_id="B3" value="14" lower_limit="4" upper_limit="23"/>
                  </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="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </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="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>percent of glottic opening</title>
          <units>percentage</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80" lower_limit="80" upper_limit="100"/>
                    <measurement group_id="B2" value="80" lower_limit="60" upper_limit="100"/>
                    <measurement group_id="B3" value="80" lower_limit="60" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).</title>
        <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue</description>
        <time_frame>30 seconds</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Macintosh Laryngoscope Blade</title>
            <description>A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
          </group>
          <group group_id="O2">
            <title>Miller Laryngoscope Blade</title>
            <description>A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
          </group>
        </group_list>
        <measure>
          <title>The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).</title>
          <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue</description>
          <units>percentage of Glottic opening</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="76" upper_limit="92"/>
                    <measurement group_id="O2" value="78" lower_limit="70" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>MAC blade lifting the tongue versus Miller blade lifting the epiglottis</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue</title>
        <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue</description>
        <time_frame>30 seconds</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Miller Blade Lifting the Epiglottis</title>
            <description>Miller blade was inserted under the epiglottis to lift it to view the glottic opening</description>
          </group>
          <group group_id="O2">
            <title>Miller Blade Lifting the Tongue</title>
            <description>Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue</title>
          <description>Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue</description>
          <units>percent of glottic opening</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.4" lower_limit="70" upper_limit="87"/>
                    <measurement group_id="O2" value="76" lower_limit="67.1" upper_limit="84.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis</title>
        <description>The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.</description>
        <time_frame>30 seconds</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MAC Blade Lifting the Tongue</title>
            <description>The MAC blade was inserted under the tongue and lifted to view the percent glottic opening</description>
          </group>
          <group group_id="O2">
            <title>MAC Blade Lifting the Epiglottis</title>
            <description>The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis</title>
          <description>The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.</description>
          <units>percent of glottic opening</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="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" lower_limit="76.5" upper_limit="92.3"/>
                    <measurement group_id="O2" value="67.2" lower_limit="56.1" upper_limit="78.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0004</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Single assessment, immediately after induction of general anesthesia</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Macintosh Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
        </group>
        <group group_id="E2">
          <title>Miller Laryngoscope Blade</title>
          <description>A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.&#xD;
Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </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>Dr. Jerrold Lerman</name_or_title>
      <organization>Women and Children's Hospital of buffalo</organization>
      <phone>716 878 7701</phone>
      <email>jerrold.lerman@gmail.com</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/NCT01717872
org study id: Lerman Blade study
nct id: NCT01717872
lead sponsor: 
has dmc: No
To compare the laryngoscopy view using two standard clinical devices, the Macintosh and
      Miller laryngoscopy blades, in infants between one day and two years of age.

      Miller blades (straight blades) are more commonly used than MacIntosh blades (curved) in
      pediatric clinical practice in some institutions especially in infants. The anatomy of infant
      airway has traditionally been considered to lend itself to advantages of the Miller blade.
      Some argue that the Miller blade offers a superior view of the laryngeal inlet because it
      lifts the epiglottis. However, others use the Miller blade to expose the larynx without
      lifting the epiglottis, supposedly to avoid traumatizing it. Despite the long-standing use of
      these blades, more than 50 years, no systematic study has ever compared the laryngoscopy
      views of the Miller and Macintosh blades in infants.
-  After Institutional Review Board approval, the patients meeting inclusion criteria will
           be selected from the Operating room elective surgical list.

        -  They will be randomized to one of the two groups: a #1 Miller or Macintosh blade.

        -  After obtaining informed consent from the parent or the legal guardian, monitors
           (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter) that are
           routine induction of anesthesia will be applied and anesthesia will be induced using an
           inhalation technique with sevoflurane, nitrous oxide and oxygen. An intravenous cannula
           will then be placed. The child will then receive a standard intubating dose of a muscle
           relaxant (rocuronium 0.5-1 mg/kg). The lungs will be mask ventilated using 100% oxygen
           in Sevoflurane for 3 minutes to allow appropriate time for the muscle relaxant to be
           fully effective. At that time, the randomized code for that child will be opened and
           laryngoscopy will be performed with either a Miller or MacIntosh blade as indicated by
           the code.

        -  The best possible glottic view will be obtained by ensuring the following steps. The
           child's head will be positioned in the Magill position, muscle relaxant will be
           administered, firm forward traction will be applied to the laryngoscope handle, and if
           needed, external laryngeal manipulation will be applied.

        -  During the same laryngoscopy, the best glottic visualization will be obtained with the
           blade lifting the epiglottis and not lifting the epiglottis, in random order (by
           flipping a coin). This difference is a matter of moving the position of the blade back
           without removing the blade from the larynx.

        -  The two views will be recorded by a second doctor using a SONY camera at the mouth
           adjacent to the laryngoscope handle.

        -  Photos of the glottic opening will be graded using the POGO scale (Ref1) by a third
           (blinded) anesthesiologist.

        -  All of the intubations and image acquisition will be performed by Drs. Yuvesh Passi,
           Jerrold Lerman or Chris Heard.

        -  The images obtained will not have patient identifiers included. They will be stored in a
           secure file once the study is completed that will be accessed only by investigators
           involved in the study.

        -  No patient identifiers will be included on any documentation apart from the source
           documents.

        -  The research data will be stored in a locked office of Dr. Lerman (Room 251) in
           Department of Anesthesia, Women and Children's Hospital of Buffalo during and after the
           study for security to protect subject privacy and confidentiality.

        -  There will be no payments or compensation to the study subjects

      The primary hypothesis of this study is to compare the view of the larynx with Miller blade
      while lifting the epiglottis to the Macintosh blade lifting the tongue, in infants and
      children <2 years of age. However, views will be obtained with the Miller and Macintosh
      blades both lifting and not lifting the epiglottis and comparisons between pairs of
      measurements will be performed. In order for to detect superiority of one technique over the
      other, we will need a difference in the POGO scores of 25 points with a standard deviation of
      25 points, yielding a sample size of 15 children in each group. To account for photographic
      difficulties, unreadable photos as well as dropouts, we will enroll 25 children in each
      group. Therefore a total of 50 children will be enrolled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).
time frame: 30 seconds
description: Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue
measure: Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue
time frame: 30 seconds
description: Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue
measure: Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis
time frame: 30 seconds
description: The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.
arm group label: Macintosh laryngoscope blade
arm group type: Active Comparator
description: A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the Percent of Glottic Opening (POGO) score by a blinded assessor.
arm group label: Miller laryngoscope blade
arm group type: Active Comparator
description: A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the percent of glottic opening score by a blinded assessor.
intervention type: Device
intervention name: Laryngoscope blade
description: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis
arm group label: Macintosh laryngoscope blade
arm group label: Miller laryngoscope blade
other name: Macintosh laryngoscope blade
other name: Miller laryngoscope blade
criteria: 
gender: All
minimum age: 1 Day
maximum age: 2 Years
healthy volunteers: No
last name: Jerrold Lerman, MD
role: Principal Investigator
affiliation: SUNY at Buffalo, Women and Children's Hospital of Buffalo
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Jerrold Lerman
investigator title: Clinical Professor of Anesthesiology
mesh term: Pyrithione zinc
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 