<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/NCT03829618</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00009727</org_study_id>
    <nct_id>NCT03829618</nct_id>
  </id_info>
  <brief_title>Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound</brief_title>
  <official_title>Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess if there is decrease in cough during flexible&#xD;
      bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration&#xD;
      are used. The modes of administration being evaluated are topical, nebulized and atomized.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID lack of cases/recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cough</measure>
    <time_frame>1 day</time_frame>
    <description>Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Post-procedure Sore Throat</measure>
    <time_frame>1 day</time_frame>
    <description>sore throat was self reported by patient as: none, mild, moderate, severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Post-Procedure Subjective Cough</measure>
    <time_frame>1 day</time_frame>
    <description>Subjective cough as described by patient as: none, mild, moderate, severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesia Time to Wake up</measure>
    <time_frame>1 day</time_frame>
    <description>time in minutes from scope out until ready for transport to post anesthesia care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alfentanyl Dosing</measure>
    <time_frame>1 day</time_frame>
    <description>Total alfentanyl dosing by anesthesia in mcg/kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Propofol Dosing</measure>
    <time_frame>1 day</time_frame>
    <description>Total propofol dosing by anesthesia in mg/kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fentanyl Dosing</measure>
    <time_frame>1 day</time_frame>
    <description>total fentanyl dosing by anesthesia in mcg/kg</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Bronchiectasis Adult</condition>
  <condition>Mediastinal Lymphadenopathy</condition>
  <condition>Pneumonia</condition>
  <condition>Chest--Diseases</condition>
  <condition>Infiltrates</condition>
  <condition>Bronchopulmonary Disease</condition>
  <condition>Cancer, Lung</condition>
  <arm_group>
    <arm_group_label>Topical Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebuliser Solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nebuliser Suspension</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical lidocaine</intervention_name>
    <description>1% lidocaine topically applied in 4 mL aliquots</description>
    <arm_group_label>Topical Lidocaine</arm_group_label>
    <other_name>Topical</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nebuliser solution</intervention_name>
    <description>2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
    <arm_group_label>Nebuliser Solution</arm_group_label>
    <other_name>Nebulizer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nebuliser Suspension</intervention_name>
    <description>2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
    <arm_group_label>Nebuliser Suspension</arm_group_label>
    <other_name>Atomizer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial&#xD;
             ultrasound evaluation and transbronchial needle aspiration.&#xD;
&#xD;
          -  Diagnosis of pulmonary disease requiring flexible bronchoscopy&#xD;
&#xD;
          -  Greater than 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any intervention beyond flexible bronchoscopy and endobronchial ultrasound&#xD;
&#xD;
          -  Inability to tolerate bronchoscopy.&#xD;
&#xD;
          -  Patients that receive paralytics.&#xD;
&#xD;
          -  Patients with neuromuscular diseases.&#xD;
&#xD;
          -  Inability to consent for procedures.&#xD;
&#xD;
          -  Allergies to lidocaine or any other drugs used in protocol.&#xD;
&#xD;
          -  Existing renal insufficiency or liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Toth</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.</citation>
    <PMID>29346249</PMID>
  </reference>
  <reference>
    <citation>Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.</citation>
    <PMID>16162784</PMID>
  </reference>
  <reference>
    <citation>Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.</citation>
    <PMID>22045879</PMID>
  </reference>
  <reference>
    <citation>Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.</citation>
    <PMID>27614989</PMID>
  </reference>
  <results_reference>
    <citation>Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.</citation>
    <PMID>28891835</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>September 8, 2021</results_first_submitted>
  <results_first_submitted_qc>October 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2021</results_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Jennifer Toth</investigator_full_name>
    <investigator_title>Professor of Medicine and Surgery, Director of Interventional Pulmonology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Bronchiectasis</mesh_term>
    <mesh_term>Lymphadenopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03829618/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants will be Identified from pool of patients who will already be undergoing with planned flexible bronchoscopy and/or endobronchial ultrasound by an interventional pulmonologist in the operating room setting. They will be identified by review of the operating room schedule and through the interventional pulmonology clinic.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Topical Lidocaine</title>
          <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
        </group>
        <group group_id="P2">
          <title>Nebuliser Solution</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
        </group>
        <group group_id="P3">
          <title>Atomizer Solution</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</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="7"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Topical Lidocaine</title>
          <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
        </group>
        <group group_id="B2">
          <title>Nebuliser Solution</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
        </group>
        <group group_id="B3">
          <title>Atomizer Solution</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
        </group>
        <group group_id="B4">
          <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="7"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="29"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="66.80" spread="12.81"/>
                    <measurement group_id="B2" value="55.57" spread="16.83"/>
                    <measurement group_id="B3" value="57.43" spread="14.77"/>
                    <measurement group_id="B4" value="61.83" spread="14.75"/>
                  </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="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.19" spread="6.93"/>
                    <measurement group_id="B2" value="29.39" spread="4.84"/>
                    <measurement group_id="B3" value="28.53" spread="8.23"/>
                    <measurement group_id="B4" value="29.59" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>currently smoking</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>quit smoking</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>never smoked</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cough</title>
        <description>Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Cough</title>
          <description>Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl</description>
          <units>coughs</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="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="1.70"/>
                    <measurement group_id="O2" value="1.71" spread="1.60"/>
                    <measurement group_id="O3" value="1.00" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Post-procedure Sore Throat</title>
        <description>sore throat was self reported by patient as: none, mild, moderate, severe</description>
        <time_frame>1 day</time_frame>
        <population>The analysis population does not include subjects who left clinic prior to collection of this data</population>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-procedure Sore Throat</title>
          <description>sore throat was self reported by patient as: none, mild, moderate, severe</description>
          <population>The analysis population does not include subjects who left clinic prior to collection of this data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>none</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Post-Procedure Subjective Cough</title>
        <description>Subjective cough as described by patient as: none, mild, moderate, severe</description>
        <time_frame>1 day</time_frame>
        <population>The analysis population does not include subjects who left clinic prior to collection of this data.</population>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-Procedure Subjective Cough</title>
          <description>Subjective cough as described by patient as: none, mild, moderate, severe</description>
          <population>The analysis population does not include subjects who left clinic prior to collection of this data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>none</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anesthesia Time to Wake up</title>
        <description>time in minutes from scope out until ready for transport to post anesthesia care unit</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Anesthesia Time to Wake up</title>
          <description>time in minutes from scope out until ready for transport to post anesthesia care unit</description>
          <units>minutes</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="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.47" spread="4.02"/>
                    <measurement group_id="O2" value="13.00" spread="5.77"/>
                    <measurement group_id="O3" value="6.14" spread="3.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alfentanyl Dosing</title>
        <description>Total alfentanyl dosing by anesthesia in mcg/kg</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Alfentanyl Dosing</title>
          <description>Total alfentanyl dosing by anesthesia in mcg/kg</description>
          <units>mcg/kg</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="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.61" spread="22.64"/>
                    <measurement group_id="O2" value="47.99" spread="37.41"/>
                    <measurement group_id="O3" value="4.40" spread="7.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Propofol Dosing</title>
        <description>Total propofol dosing by anesthesia in mg/kg</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Propofol Dosing</title>
          <description>Total propofol dosing by anesthesia in mg/kg</description>
          <units>mg/kg</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="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.30" spread="3.23"/>
                    <measurement group_id="O2" value="6.93" spread="3.36"/>
                    <measurement group_id="O3" value="3.26" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fentanyl Dosing</title>
        <description>total fentanyl dosing by anesthesia in mcg/kg</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Topical Lidocaine</title>
            <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
          </group>
          <group group_id="O2">
            <title>Nebuliser Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
          </group>
          <group group_id="O3">
            <title>Atomizer Solution</title>
            <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
          </group>
        </group_list>
        <measure>
          <title>Fentanyl Dosing</title>
          <description>total fentanyl dosing by anesthesia in mcg/kg</description>
          <units>mcg/kg</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="7"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="0.28"/>
                    <measurement group_id="O2" value="0.24" spread="0.23"/>
                    <measurement group_id="O3" value="0.48" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data collected in the post-anesthesia care unit up to 1 hour after procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Topical Lidocaine</title>
          <description>16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.&#xD;
Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots</description>
        </group>
        <group group_id="E2">
          <title>Nebuliser Solution</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.&#xD;
Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer</description>
        </group>
        <group group_id="E3">
          <title>Nebuliser Suspension</title>
          <description>2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.&#xD;
Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <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="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </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="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
              </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>The target enrollment was not reached secondary to the COVID-19 pandemic.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Zoulfira Nisnevitch-Savarese, M.D.</name_or_title>
      <organization>Penn State Hershey Medical Center</organization>
      <phone>717-531-6597</phone>
      <email>znisnevitchsavarese@pennstatehealth.psu.edu</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/NCT03829618
org study id: STUDY00009727
nct id: NCT03829618
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess if there is decrease in cough during flexible
      bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration
      are used. The modes of administration being evaluated are topical, nebulized and atomized.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cough
time frame: 1 day
description: Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
measure: Number of Participants With Post-procedure Sore Throat
time frame: 1 day
description: sore throat was self reported by patient as: none, mild, moderate, severe
measure: Number of Participants With Post-Procedure Subjective Cough
time frame: 1 day
description: Subjective cough as described by patient as: none, mild, moderate, severe
measure: Anesthesia Time to Wake up
time frame: 1 day
description: time in minutes from scope out until ready for transport to post anesthesia care unit
measure: Alfentanyl Dosing
time frame: 1 day
description: Total alfentanyl dosing by anesthesia in mcg/kg
measure: Propofol Dosing
time frame: 1 day
description: Total propofol dosing by anesthesia in mg/kg
measure: Fentanyl Dosing
time frame: 1 day
description: total fentanyl dosing by anesthesia in mcg/kg
arm group label: Topical Lidocaine
arm group type: Active Comparator
description: 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.
arm group label: Nebuliser Solution
arm group type: Active Comparator
description: 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.
arm group label: Nebuliser Suspension
arm group type: Active Comparator
description: 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.
intervention type: Drug
intervention name: Topical lidocaine
description: 1% lidocaine topically applied in 4 mL aliquots
arm group label: Topical Lidocaine
other name: Topical
intervention type: Drug
intervention name: Nebuliser solution
description: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
arm group label: Nebuliser Solution
other name: Nebulizer
intervention type: Drug
intervention name: Nebuliser Suspension
description: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
arm group label: Nebuliser Suspension
other name: Atomizer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Toth
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
citation: Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.
PMID: 29346249
citation: Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.
PMID: 16162784
citation: Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
PMID: 22045879
citation: Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.
PMID: 27614989
citation: Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.
PMID: 28891835
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Jennifer Toth
investigator title: Professor of Medicine and Surgery, Director of Interventional Pulmonology
mesh term: Lung Neoplasms
mesh term: Bronchiectasis
mesh term: Lymphadenopathy
mesh term: Lidocaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The target enrollment was not reached secondary to the COVID-19 pandemic.
point of contact: 