<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/NCT02262442</url>
  </required_header>
  <id_info>
    <org_study_id>14-074</org_study_id>
    <secondary_id>EK 177/14</secondary_id>
    <nct_id>NCT02262442</nct_id>
  </id_info>
  <brief_title>Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy</brief_title>
  <acronym>EnkAtomizerII</acronym>
  <official_title>Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective study is to examine the benefits and risks of administration of&#xD;
      local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)&#xD;
      during flexible bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of anaesthetics during flexible bronchoscopy</measure>
    <time_frame>one hour</time_frame>
    <description>Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy.&#xD;
Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pCO2</measure>
    <time_frame>two hours</time_frame>
    <description>Determination of:&#xD;
maximum transcutaneous pCO2 during bronchoscopy, mean transcutaneous pCO2 during bronchoscopy, capillary pCO2 immediately after bronchoscopy and 2 hours later, time to Aldrete Score of at least 9 after procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Flexible Bronchoscopy</condition>
  <arm_group>
    <arm_group_label>Working channel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive local anaesthetics via the working channel of the bronchoscope.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enk Fiberoptic Atomizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Enk Fiberoptic Atomizer</intervention_name>
    <description>Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy</description>
    <arm_group_label>Enk Fiberoptic Atomizer</arm_group_label>
    <other_name>Enk Fiberoptic Atomizer Set, Cook Medical</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bronchoscope</intervention_name>
    <description>Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy</description>
    <arm_group_label>Working channel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic&#xD;
             purposes (seed extraction in unclear infiltrates, interstitial lung disease,&#xD;
             unexplained pulmonary opacities, inspection at hemoptysis)&#xD;
&#xD;
          -  patients aged 18 years or above&#xD;
&#xD;
          -  written informed consent prior to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to local anesthetics, midazolam or propofol, known epilepsy, known&#xD;
             severe neurological or psychiatric disorder, hemodynamic instability with need for&#xD;
             vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure&#xD;
             with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 &gt; 55&#xD;
             mmHg) or pCO2 &gt; 50 mmHg at ambient air, known upper airway anomalies, surgery or&#xD;
             irradiation of the upper airways in the past, contraindication for transbronchial&#xD;
             biopsy as published by international guidelines, e. g. bleeding disorders or severe&#xD;
             pulmonary hypertension&#xD;
&#xD;
          -  women, who are pregnant or breastfeeding&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  expected non-compliance&#xD;
&#xD;
          -  patients unwilling or unable to give informed consent, patients with limited ability&#xD;
             to comply with instructions for this study&#xD;
&#xD;
          -  Participation on another clinical trial within the last 3 months&#xD;
&#xD;
          -  subjects who are committed to an institution and/or penitentiary by judicial or&#xD;
             official order.&#xD;
&#xD;
          -  employees of the investigator cooperation companies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Müller, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tobias Müller, Dr. med.</last_name>
    <phone>+49 241 80 36470</phone>
    <email>tobmueller@ukaachen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angela Habier, M.Sc.</last_name>
    <phone>+49 241 80 37429</phone>
    <email>ahabier@ukaachen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital</name>
      <address>
        <city>Aachen</city>
        <state>North Rhine-Westphalia</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tobias Müller, Dr. med.</last_name>
      <phone>+49 241 80 36470</phone>
      <email>tobmueller@ukaachen.de</email>
    </contact>
    <contact_backup>
      <last_name>Angela Habier, M.Sc.</last_name>
      <phone>+49 241 80 37429</phone>
      <email>ahabier@ukaachen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Tobias Müller, Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 17, 2016</last_update_submitted>
  <last_update_submitted_qc>February 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>flexible bronchoscopy</keyword>
  <keyword>anaesthetics</keyword>
  <keyword>transcutaneous pCO2</keyword>
  <keyword>capillary pCO2</keyword>
  <keyword>special atomizing set</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/NCT02262442
org study id: 14-074
secondary id: EK 177/14
nct id: NCT02262442
lead sponsor: 
has dmc: No
The aim of this prospective study is to examine the benefits and risks of administration of
      local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical)
      during flexible bronchoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Amount of anaesthetics during flexible bronchoscopy
time frame: one hour
description: Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy.
Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.
measure: pCO2
time frame: two hours
description: Determination of:
maximum transcutaneous pCO2 during bronchoscopy, mean transcutaneous pCO2 during bronchoscopy, capillary pCO2 immediately after bronchoscopy and 2 hours later, time to Aldrete Score of at least 9 after procedure
arm group label: Working channel
arm group type: Experimental
description: Patients will receive local anaesthetics via the working channel of the bronchoscope.
arm group label: Enk Fiberoptic Atomizer
arm group type: Experimental
description: Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.
intervention type: Device
intervention name: Enk Fiberoptic Atomizer
description: Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
arm group label: Enk Fiberoptic Atomizer
other name: Enk Fiberoptic Atomizer Set, Cook Medical
intervention type: Device
intervention name: bronchoscope
description: Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy
arm group label: Working channel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Tobias Müller, Dr. med.
role: Principal Investigator
affiliation: Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
last name: Tobias Müller, Dr. med.
phone: +49 241 80 36470
email: tobmueller@ukaachen.de
last name: Angela Habier, M.Sc.
phone: +49 241 80 37429
email: ahabier@ukaachen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Sponsor