<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/NCT03033979</url>
  </required_header>
  <id_info>
    <org_study_id>Schulthess_Anä_9</org_study_id>
    <nct_id>NCT03033979</nct_id>
  </id_info>
  <brief_title>Prolonged Laryngeal Mask Airway ProSealTM Use</brief_title>
  <official_title>Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schulthess Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schulthess Klinik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conclude that use of the LMA ProSealTM for prolonged procedures is&#xD;
      feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided&#xD;
      basic guidelines are followed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for&#xD;
      prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable&#xD;
      for positive pressure ventilation (needed to counter the alleged progressive respiratory&#xD;
      fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged&#xD;
      progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask&#xD;
      device with a modified cuff to facilitate ventilation and a drain tube to provide airway&#xD;
      protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM&#xD;
      for prolonged procedures; however, there are only four reports and one case series.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the LMA ProSealTM for prolonged use</measure>
    <time_frame>30 Minutes</time_frame>
    <description>Oropharyngeal leak pressure</description>
  </primary_outcome>
  <enrollment type="Actual">7</enrollment>
  <condition>Airway Management</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We describe the use of the LMA ProSealTM in seven patients in a variety of clinical&#xD;
        situations for procedures lasting more than 5 hours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 - 3&#xD;
&#xD;
          -  Age 19-85 yr&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult airway&#xD;
&#xD;
          -  Non fasted&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Christian Keller MD, M.Sc.</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033979
org study id: Schulthess_Anä_9
nct id: NCT03033979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators conclude that use of the LMA ProSealTM for prolonged procedures is
      feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided
      basic guidelines are followed.
There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for
      prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable
      for positive pressure ventilation (needed to counter the alleged progressive respiratory
      fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged
      progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask
      device with a modified cuff to facilitate ventilation and a drain tube to provide airway
      protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM
      for prolonged procedures; however, there are only four reports and one case series.
observational model: Case-Only
time perspective: Retrospective
measure: Feasibility of the LMA ProSealTM for prolonged use
time frame: 30 Minutes
description: Oropharyngeal leak pressure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No