<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/NCT02981264</url>
  </required_header>
  <id_info>
    <org_study_id>Transcricoid EBUS RCT</org_study_id>
    <nct_id>NCT02981264</nct_id>
  </id_info>
  <brief_title>Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During EBUS-TBNA</brief_title>
  <acronym>CRISPEN</acronym>
  <official_title>Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly&#xD;
      performed for diagnosis of mediastinal pathologies. The procedure can either be performed&#xD;
      under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients&#xD;
      tolerate the procedure well although cough is often reported as a distressing symptom.&#xD;
      Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia.&#xD;
      There is limited literature on the efficacy of transtracheal/transcricoid injection versus&#xD;
      spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study&#xD;
      would help to determine the procedure comfort for the patient while using the&#xD;
      transtracheal/transcricoid method vs the spray as you go method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For all patients meeting the inclusion criteria, the demographic profile including age, sex,&#xD;
      weight, smoking history shall be recorded. A written informed consent will be obtained from&#xD;
      all participants. The patients who undergo EBUS-TBNA under moderate sedation would be&#xD;
      randomised in a one is to one ratio either to transcricoid injection or spray as you go&#xD;
      lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse&#xD;
      oximetry saturation will be recorded at the baseline Patients in both the groups shall be&#xD;
      prepared in a similar fashion except for the use of transcricoid injection in one group.&#xD;
&#xD;
      During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the&#xD;
      bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall&#xD;
      initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine&#xD;
      using the spray as you go method. The total lignocaine dose during the procedure will be&#xD;
      recorded. The patients would be monitored for any adverse effects throughout the procedure.&#xD;
      The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of&#xD;
      cough and overall procedure satisfaction. An audio recorder shall be used to record the cough&#xD;
      count during the entire procedure.&#xD;
&#xD;
      Post procedure, patients will record the pain experienced while undergoing the procedure on&#xD;
      the VAS scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall cough count</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
    <description>Cough count till reaching carina</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operator rated overall procedure satisfaction</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Operator rated satisfaction on VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from scope insertion to crossing the vocal cords</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
    <description>Time in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall procedure duration</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
    <description>Time in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Lignocaine dose</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
    <description>Total dose of lignocaine in milligrams</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">365</enrollment>
  <condition>Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Transcricoid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lignocaine delivery using transcricoid injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spray as You go</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lignocaine delivery using spray as you go method</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Transcricoid Injection</intervention_name>
    <arm_group_label>Transcricoid</arm_group_label>
    <other_name>Lignocaine delivered through the cricothyroid membrane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spray as you go</intervention_name>
    <arm_group_label>Spray as You go</arm_group_label>
    <other_name>Lignocaine delivered through the bronchoscope working channel.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for EBUS TBNA&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent&#xD;
&#xD;
          -  Known documented hypersensitivity to lignocaine&#xD;
&#xD;
          -  Procedure performed under general anaesthesia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hypoxemia (oxygen saturation [by pulse oximetry] &lt; 92% with Fio2 of ≥ 0.3&#xD;
&#xD;
          -  Bronchoscopy done through endotracheal or tracheostomy tube&#xD;
&#xD;
          -  Midline neck mass or thyroid enlargement making the identification of&#xD;
&#xD;
          -  cricothyroid membrane difficult'&#xD;
&#xD;
          -  Patients with central airway obstruction&#xD;
&#xD;
          -  Patients with active ongoing hemoptysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randeep Guleria, MD, DM</last_name>
    <role>Study Chair</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AIIMS</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Karan Madan</investigator_full_name>
    <investigator_title>Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders</investigator_title>
  </responsible_party>
  <keyword>Bronchoscopy</keyword>
  <keyword>Lignocaine</keyword>
  <keyword>Endobronchial Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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>Yes</sharing_ipd>
    <ipd_description>The data on demographics and outcomes shall be available on reasonable request</ipd_description>
    <ipd_time_frame>For two years since the study completion</ipd_time_frame>
    <ipd_access_criteria>Available on reasonable request</ipd_access_criteria>
  </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/NCT02981264
org study id: Transcricoid EBUS RCT
nct id: NCT02981264
lead sponsor: 
has dmc: Yes
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly
      performed for diagnosis of mediastinal pathologies. The procedure can either be performed
      under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients
      tolerate the procedure well although cough is often reported as a distressing symptom.
      Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia.
      There is limited literature on the efficacy of transtracheal/transcricoid injection versus
      spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study
      would help to determine the procedure comfort for the patient while using the
      transtracheal/transcricoid method vs the spray as you go method.
For all patients meeting the inclusion criteria, the demographic profile including age, sex,
      weight, smoking history shall be recorded. A written informed consent will be obtained from
      all participants. The patients who undergo EBUS-TBNA under moderate sedation would be
      randomised in a one is to one ratio either to transcricoid injection or spray as you go
      lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse
      oximetry saturation will be recorded at the baseline Patients in both the groups shall be
      prepared in a similar fashion except for the use of transcricoid injection in one group.

      During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the
      bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall
      initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine
      using the spray as you go method. The total lignocaine dose during the procedure will be
      recorded. The patients would be monitored for any adverse effects throughout the procedure.
      The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of
      cough and overall procedure satisfaction. An audio recorder shall be used to record the cough
      count during the entire procedure.

      Post procedure, patients will record the pain experienced while undergoing the procedure on
      the VAS scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Overall cough count
time frame: At study completion approximately 12 months
description: Cough count till reaching carina
measure: Operator rated overall procedure satisfaction
time frame: Through study completion, an average of 1 year
description: Operator rated satisfaction on VAS scale
measure: Time from scope insertion to crossing the vocal cords
time frame: At study completion approximately 12 months
description: Time in seconds
measure: Overall procedure duration
time frame: At study completion approximately 12 months
description: Time in minutes
measure: Total Lignocaine dose
time frame: At study completion approximately 12 months
description: Total dose of lignocaine in milligrams
arm group label: Transcricoid
arm group type: Active Comparator
description: Lignocaine delivery using transcricoid injection
arm group label: Spray as You go
arm group type: Active Comparator
description: Lignocaine delivery using spray as you go method
intervention type: Drug
intervention name: Transcricoid Injection
arm group label: Transcricoid
other name: Lignocaine delivered through the cricothyroid membrane
intervention type: Drug
intervention name: Spray as you go
arm group label: Spray as You go
other name: Lignocaine delivered through the bronchoscope working channel.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Randeep Guleria, MD, DM
role: Study Chair
affiliation: All India Institute of Medical Sciences, New Delhi
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Karan Madan
investigator title: Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders
mesh term: Lung Diseases
mesh term: Lidocaine
sharing ipd: Yes
ipd description: The data on demographics and outcomes shall be available on reasonable request
ipd time frame: For two years since the study completion
ipd access criteria: Available on reasonable request