<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/NCT02237651</url>
  </required_header>
  <id_info>
    <org_study_id>MHH 09/03/2014</org_study_id>
    <nct_id>NCT02237651</nct_id>
  </id_info>
  <brief_title>Topical Anesthesia / Bronchoscopy</brief_title>
  <acronym>TNA</acronym>
  <official_title>Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hannover Medical School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™&#xD;
      Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical&#xD;
      nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl&#xD;
      Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients included in the first half of the study (topical anesthesia with the Laryngeal&#xD;
      atomizer) and with need for another bronchoscopy in the second half of the study (topical&#xD;
      anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the&#xD;
      questionnaire after the second bronchoscopy to allow in-patient comparison.&#xD;
&#xD;
      Description of the primary efficacy analysis and population:&#xD;
&#xD;
      The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical&#xD;
      nasopharyngeal anesthesia for bronchoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Equally</measure>
    <time_frame>30 min.</time_frame>
    <description>The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">252</enrollment>
  <condition>Equally of Delivery Systems of Local Anesthesia in Bronchoscopy</condition>
  <arm_group>
    <arm_group_label>topical anesthesia multi-use device</arm_group_label>
    <description>anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany</description>
  </arm_group>
  <arm_group>
    <arm_group_label>topical anesthesia Intranasal Mucosal Atomization</arm_group_label>
    <description>single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>topical anesthesia multi-use device</intervention_name>
    <arm_group_label>topical anesthesia multi-use device</arm_group_label>
    <other_name>anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>topical anesthesia Intranasal Mucosal Atomization</intervention_name>
    <arm_group_label>topical anesthesia Intranasal Mucosal Atomization</arm_group_label>
    <other_name>single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients after lung transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients after lung transplantation (single, double or combined)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  outpatient bronchoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oxygen requirement at rest&#xD;
&#xD;
          -  Need for peri-interventional sedation&#xD;
&#xD;
          -  limited German language skills or other reasons which might impair patient&#xD;
             communication or computer handling&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Fuehner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dep. Respiratory Medicine, Hannover Medical School</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 19, 2015</last_update_submitted>
  <last_update_submitted_qc>August 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anesthesia</keyword>
  <keyword>bronchosocopy</keyword>
  <keyword>lung transplantation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02237651
org study id: MHH 09/03/2014
nct id: NCT02237651
lead sponsor: 
has dmc: Yes
The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™
      Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical
      nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl
      Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.
Patients included in the first half of the study (topical anesthesia with the Laryngeal
      atomizer) and with need for another bronchoscopy in the second half of the study (topical
      anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the
      questionnaire after the second bronchoscopy to allow in-patient comparison.

      Description of the primary efficacy analysis and population:

      The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical
      nasopharyngeal anesthesia for bronchoscopy.
observational model: Cohort
time perspective: Prospective
measure: Equally
time frame: 30 min.
description: The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.
arm group label: topical anesthesia multi-use device
description: anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany
arm group label: topical anesthesia Intranasal Mucosal Atomization
description: single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia
intervention type: Device
intervention name: topical anesthesia multi-use device
arm group label: topical anesthesia multi-use device
other name: anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany
intervention type: Device
intervention name: topical anesthesia Intranasal Mucosal Atomization
arm group label: topical anesthesia Intranasal Mucosal Atomization
other name: single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 88 Years
healthy volunteers: No
last name: Thomas Fuehner, MD
role: Principal Investigator
affiliation: Hannover Medical School
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Anesthetics