<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/NCT02981277</url>
  </required_header>
  <id_info>
    <org_study_id>Transcricoid RCT</org_study_id>
    <nct_id>NCT02981277</nct_id>
  </id_info>
  <brief_title>Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Bronchoscopy</brief_title>
  <acronym>CRISP</acronym>
  <official_title>Transcricoid Injection Versus Spray as You go Method for Local Anaesthesia During Flexible Bronchoscopy: 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>
      Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various&#xD;
      bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often&#xD;
      reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be&#xD;
      significantly improved with control of cough. Use of sedation during bronchoscopy has been&#xD;
      reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is&#xD;
      routinely performed at many centres including ours.&#xD;
&#xD;
      Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is&#xD;
      limited literature on the efficacy of transtracheal/transcricoid injection versus spray as&#xD;
      you go method for lignocaine delivery to the airways during bronchoscopy. This study would&#xD;
      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 and the type of procedures performed during bronchoscopy shall be&#xD;
      recorded. A written informed consent will be obtained from all participants. The patients who&#xD;
      undergo flexible bronchoscopy would be randomised in a one is to one ratio either to&#xD;
      transcricoid or spray as you go group. Prior to the bronchoscopy blood pressure, pulse rate,&#xD;
      respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in&#xD;
      both the groups shall be prepared in a similar fashion except for the initial route of&#xD;
      lignocaine delivery.&#xD;
&#xD;
      During the procedure, 1.5 ml aliquots of 2% 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 instilled transtracheally along with two&#xD;
      baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2%&#xD;
      lignocaine using the spray as you go method. The total lignocaine dose during the procedure&#xD;
      will be recorded. The patients would be monitored for any adverse effects throughout the&#xD;
      procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the&#xD;
      severity of cough and overall procedure satisfaction. Cough count shall be noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Cough count from bronchoscope introduction till reaching the carina</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
  </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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall procedure duration</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Lignocaine dose</measure>
    <time_frame>At study completion approximately 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operator rated overall procedure satisfaction</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</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>
    <description>Lignocaine delivery using Transcricoid Injection</description>
    <arm_group_label>Transcricoid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spray as you go</intervention_name>
    <description>Lignocaine delivery using Spray as you go method</description>
    <arm_group_label>Spray as You go</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for diagnostic or therapeutic flexible bronchoscopy&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Hemodynamic stability (defined as systolic BP &gt;100 mm Hg and, &lt;180 mm Hg).&#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 cricothyroid&#xD;
             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>All India Institute of Medical Sciences</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 2018</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 23, 2018</last_update_submitted>
  <last_update_submitted_qc>November 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02981277
org study id: Transcricoid RCT
nct id: NCT02981277
lead sponsor: 
has dmc: Yes
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various
      bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often
      reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be
      significantly improved with control of cough. Use of sedation during bronchoscopy has been
      reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is
      routinely performed at many centres including ours.

      Topical lignocaine is administered during bronchoscopy 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 bronchoscopy. 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 and the type of procedures performed during bronchoscopy shall be
      recorded. A written informed consent will be obtained from all participants. The patients who
      undergo flexible bronchoscopy would be randomised in a one is to one ratio either to
      transcricoid or spray as you go group. Prior to the bronchoscopy 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 initial route of
      lignocaine delivery.

      During the procedure, 1.5 ml aliquots of 2% 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 instilled transtracheally along with two
      baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2%
      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 2 VAS charts to mark the
      severity of cough and overall procedure satisfaction. Cough count shall be noted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Cough count from bronchoscope introduction till reaching the carina
time frame: At study completion approximately 12 months
measure: Time from scope insertion to crossing the vocal cords
time frame: At study completion approximately 12 months
measure: Overall procedure duration
time frame: At study completion approximately 12 months
measure: Total Lignocaine dose
time frame: At study completion approximately 12 months
measure: Operator rated overall procedure satisfaction
time frame: Through study completion, an average of 1 year
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
description: Lignocaine delivery using Transcricoid Injection
arm group label: Transcricoid
intervention type: Drug
intervention name: Spray as you go
description: Lignocaine delivery using Spray as you go method
arm group label: Spray as You go
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
sharing ipd: Undecided