<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/NCT01685320</url>
  </required_header>
  <id_info>
    <org_study_id>PressureCara</org_study_id>
    <nct_id>NCT01685320</nct_id>
  </id_info>
  <brief_title>Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study</brief_title>
  <official_title>Force and Pressure Distribution Using Macintosh and GlideScope Laryngoscopes in Normal Airway: an in Vivo Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Forces applied on soft upper tissues by different laryngoscope blades during direct&#xD;
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to&#xD;
      the patients. The aim of this study is to compare the force and pressure applied to soft&#xD;
      tissue in order to achieve the same glottis view comparing direct laryngoscopy and&#xD;
      videolaryngoscopy in vivo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forces applied on soft upper tissues by different laryngoscope blades during direct&#xD;
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to&#xD;
      the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic&#xD;
      changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.&#xD;
&#xD;
      In order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of&#xD;
      an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes&#xD;
      alignment, thereby reducing the detrimental effects above mentioned.&#xD;
&#xD;
      The aim of this study is to measure the minimal force exertion to achieve not only glottis&#xD;
      view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in&#xD;
      patients with normal airway conditions. Furthermore, The investigators measured the following&#xD;
      parameters: pressure distribution upon the blade; time required to visualize the glottis;&#xD;
      time required to complete oro-tracheal intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.</measure>
    <time_frame>Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia</time_frame>
    <description>The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation</measure>
    <time_frame>On average 20 seconds</time_frame>
    <description>Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Tracheal Intubation</condition>
  <condition>Laryngoscopy</condition>
  <arm_group>
    <arm_group_label>Direct laryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes cases in which the forces applied by Macintosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indirect laryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Forces applied by laryngoscope</intervention_name>
    <description>Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.</description>
    <arm_group_label>Direct laryngoscope</arm_group_label>
    <arm_group_label>Indirect laryngoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients classified as American Society of Anesthesiologists physical status (ASA-PS)&#xD;
             class 1 or 2&#xD;
&#xD;
          -  Patients whose intubation was associated with a Cormack-Lehane grade 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 yrs&#xD;
&#xD;
          -  older than 65 yrs&#xD;
&#xD;
          -  body-mass index (BMI) between 18 and 30&#xD;
&#xD;
          -  predicted difficult intubation according to SIAARTI (Italian Society Anaesthesia,&#xD;
             Analgesia, Resuscitation and Intensive Care)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimiliano Carassiti, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campus BioMedico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Campus BioMedico</name>
      <address>
        <city>Rome</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agro FE. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal and difficult airways: a manikin study. Br J Anaesth. 2012 Jan;108(1):146-51. doi: 10.1093/bja/aer304. Epub 2011 Sep 28.</citation>
    <PMID>21965048</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>February 8, 2013</results_first_submitted>
  <results_first_submitted_qc>February 8, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 13, 2013</results_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Massimiliano Carassiti</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Force</keyword>
  <keyword>Pressure</keyword>
  <keyword>Intubation</keyword>
  <keyword>laryngoscopy</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Date of recruitment period: January-October 2011. Type of location: Dept. of Anaesthesia, University School of Medicine Campus Bio-Medico, Rome, Italy.</recruitment_details>
      <pre_assignment_details>After written consent, thirty adult patients scheduled for elective surgery under general anaesthesia (age between 18 and 65 years, body-mass index between 18 and 30, classified as ASA-PS class 1 or 2), were included in this study. Subjects likely to be difficult to intubate, according to the SIAARTI Recommendations, were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Direct Laryngoscope</title>
          <description>Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
        </group>
        <group group_id="P2">
          <title>Indirect Laryngoscope</title>
          <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </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 Laryngoscope</title>
          <description>Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
        </group>
        <group group_id="B2">
          <title>Indirect Laryngoscope</title>
          <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="41" spread="12"/>
                    <measurement group_id="B2" value="44" spread="11"/>
                    <measurement group_id="B3" value="42.5" spread="12"/>
                  </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="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </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>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.</title>
        <description>The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.</description>
        <time_frame>Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia</time_frame>
        <population>We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscope</title>
            <description>Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
          </group>
          <group group_id="O2">
            <title>Indirect Laryngoscope</title>
            <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
          </group>
        </group_list>
        <measure>
          <title>Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.</title>
          <description>The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.</description>
          <population>We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.</population>
          <units>Newton</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Measurements during glottis visualization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="6"/>
                    <measurement group_id="O2" value="10" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Measurements during intubation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="14"/>
                    <measurement group_id="O2" value="8" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation</title>
        <description>Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.</description>
        <time_frame>On average 20 seconds</time_frame>
        <population>We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Direct Laryngoscope</title>
            <description>Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
          </group>
          <group group_id="O2">
            <title>Indirect Laryngoscope</title>
            <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation</title>
          <description>Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.</description>
          <population>We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time measured during glottis visualization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="1"/>
                    <measurement group_id="O2" value="7" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time measured during intubation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" spread="3"/>
                    <measurement group_id="O2" value="20" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious and/or other non-serious adverse events were not collected/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Direct Laryngoscope</title>
          <description>Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</description>
        </group>
        <group group_id="E2">
          <title>Indirect Laryngoscope</title>
          <description>Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.</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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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>
    <limitations_and_caveats>Patients studied were classified with &quot;normal airways&quot;, while difficult intubations were not considered.&#xD;
We excluded patients with CL grade 2 or greater.&#xD;
We employed only the Macintosh size 3 blade to avoid additional variables.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Prof. Massimiliano Carassiti</name_or_title>
      <organization>Campus Bio-medico University</organization>
      <phone>+39-06-225411952</phone>
      <email>m.carassiti@unicampus.it</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/NCT01685320
org study id: PressureCara
nct id: NCT01685320
lead sponsor: 
has dmc: Yes
Forces applied on soft upper tissues by different laryngoscope blades during direct
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to
      the patients. The aim of this study is to compare the force and pressure applied to soft
      tissue in order to achieve the same glottis view comparing direct laryngoscopy and
      videolaryngoscopy in vivo.
Forces applied on soft upper tissues by different laryngoscope blades during direct
      laryngoscopy and intubation are considered to be major stimuli to cause serious damages to
      the patients, such as local injures to incisors, larynx and spinal column, or hemodynamic
      changes in heart rate and/or blood pressure due to autonomic nervous system stimulation.

      In order to reduce risk of such injures, indirect videolaryngoscopy provides the advantage of
      an easier laryngeal visualization with less need for the mouth-pharyngeal-laryngeal axes
      alignment, thereby reducing the detrimental effects above mentioned.

      The aim of this study is to measure the minimal force exertion to achieve not only glottis
      view but also a successful intubation, comparing GlideScope and Macintosh laryngoscope, in
      patients with normal airway conditions. Furthermore, The investigators measured the following
      parameters: pressure distribution upon the blade; time required to visualize the glottis;
      time required to complete oro-tracheal intubation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.
time frame: Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia
description: The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.
measure: Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation
time frame: On average 20 seconds
description: Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.
arm group label: Direct laryngoscope
arm group type: Active Comparator
description: Includes cases in which the forces applied by Macintosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.
arm group label: Indirect laryngoscope
arm group type: Active Comparator
description: Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured.
intervention type: Procedure
intervention name: Forces applied by laryngoscope
description: Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
arm group label: Direct laryngoscope
arm group label: Indirect laryngoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Massimiliano Carassiti, Professor
role: Principal Investigator
affiliation: Campus BioMedico
facility: 
country: Italy
citation: Carassiti M, Zanzonico R, Cecchini S, Silvestri S, Cataldo R, Agro FE. Force and pressure distribution using Macintosh and GlideScope laryngoscopes in normal and difficult airways: a manikin study. Br J Anaesth. 2012 Jan;108(1):146-51. doi: 10.1093/bja/aer304. Epub 2011 Sep 28.
PMID: 21965048
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Massimiliano Carassiti
investigator title: Professor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Patients studied were classified with "normal airways", while difficult intubations were not considered.
We excluded patients with CL grade 2 or greater.
We employed only the Macintosh size 3 blade to avoid additional variables.
point of contact: 