<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/NCT01679626</url>
  </required_header>
  <id_info>
    <org_study_id>2011-06</org_study_id>
    <nct_id>NCT01679626</nct_id>
  </id_info>
  <brief_title>Airway Manoeuvers - Implications for Airway Management?</brief_title>
  <official_title>The Effect of Cricoid Pressure and Backward Upward Rightward Pressure on Airway Dimensions - Implications for Airway Management?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In anesthesia, intubation is a technique used to secure an airway. This technique is not&#xD;
      always straightforward. Sometimes it is difficult to place an endotracheal tube. There are&#xD;
      two manners of giving pressure to the patients neck, to improve view and facilitate&#xD;
      intubation.&#xD;
&#xD;
      The investigators hypothesize that by giving this pressure the effective work area is likely&#xD;
      to be smaller. The investigators would like to quantify this effect by measuring the&#xD;
      effective work area, using a specially designed computer program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are&#xD;
      extralaryngeal manoeuvers which are widely applied during endotracheal intubation,&#xD;
      respectively offering potential protection against passive gastric regurgitation and improved&#xD;
      laryngeal view in emergency airway management.&#xD;
&#xD;
      Their validity in achieving an improvement of the laryngeal view has been questioned.&#xD;
&#xD;
      The objective of this study is to measure the change in mean anterior-posterior rima&#xD;
      glottidis (APRIMA) distance and mean area under the vocal cords after backward upward&#xD;
      rightward pressure (BURP) and cricoid pressure (CP).&#xD;
&#xD;
      The investigators will measure the APRIMA distances and areas under the vocal cords, using a&#xD;
      specially created module in the program DeVIDE. The measurements assessed during BURP and CP&#xD;
      will be expressed relative to the measurements when no external pressure is applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <enrollment type="Actual">200</enrollment>
  <condition>Airway Management</condition>
  <eligibility>
    <study_pop>
      <textblock>
        200 consecutive adult patients scheduled for elective surgery requiring endotracheal&#xD;
        intubation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 200 consecutive adult patients scheduled for elective surgery requiring endotracheal&#xD;
        intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 35 kg.m-2);&#xD;
&#xD;
          -  chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  history of difficult intubation;&#xD;
&#xD;
          -  mouth opening &lt; 3 cm;&#xD;
&#xD;
          -  inadequate neck mobility;&#xD;
&#xD;
          -  history of oropharyngeal pathology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Ralph Maassen</investigator_full_name>
    <investigator_title>MD, principal investigator</investigator_title>
  </responsible_party>
  <keyword>cricoid pressure (CP)</keyword>
  <keyword>backward upward rightward pressure (BURP)</keyword>
  <keyword>AP-rima distances</keyword>
  <keyword>Glottic area</keyword>
  <keyword>Extralaryngeal manoeuvres</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01679626
org study id: 2011-06
nct id: NCT01679626
lead sponsor: 
has dmc: Yes
In anesthesia, intubation is a technique used to secure an airway. This technique is not
      always straightforward. Sometimes it is difficult to place an endotracheal tube. There are
      two manners of giving pressure to the patients neck, to improve view and facilitate
      intubation.

      The investigators hypothesize that by giving this pressure the effective work area is likely
      to be smaller. The investigators would like to quantify this effect by measuring the
      effective work area, using a specially designed computer program.
Cricoid pressure (CP) and the backward-upward-rightward pressure (BURP) manoeuver, are
      extralaryngeal manoeuvers which are widely applied during endotracheal intubation,
      respectively offering potential protection against passive gastric regurgitation and improved
      laryngeal view in emergency airway management.

      Their validity in achieving an improvement of the laryngeal view has been questioned.

      The objective of this study is to measure the change in mean anterior-posterior rima
      glottidis (APRIMA) distance and mean area under the vocal cords after backward upward
      rightward pressure (BURP) and cricoid pressure (CP).

      The investigators will measure the APRIMA distances and areas under the vocal cords, using a
      specially created module in the program DeVIDE. The measurements assessed during BURP and CP
      will be expressed relative to the measurements when no external pressure is applied.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Ralph Maassen
investigator title: MD, principal investigator