<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/NCT04440787</url>
  </required_header>
  <id_info>
    <org_study_id>RES/SCM/30/2018/81</org_study_id>
    <nct_id>NCT04440787</nct_id>
  </id_info>
  <brief_title>Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure</brief_title>
  <official_title>To Evaluate &quot;Three Point Cuff Palpation Technique&quot; for Assessing Optimal Depth of Endotracheal Tube Placement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rajiv Gandhi Cancer Institute &amp; Research Center, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rajiv Gandhi Cancer Institute &amp; Research Center, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff&#xD;
      at three sites (just below the cricoid cartilage, at suprasternal level and just below&#xD;
      suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of&#xD;
      endotracheal tube and carina. This distance will be measured repeatedly, after&#xD;
      pneumoperitoneum, after trendelenburg position and after making the patient supine at the end&#xD;
      of surgery. Change in the distance will be noted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The endotracheal tube (ETT) will be placed according to the black mark on the tube,&#xD;
      post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three&#xD;
      sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT&#xD;
      cuff position will be scanned by sonography of airway to confirm the position of the proximal&#xD;
      end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of&#xD;
      endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after&#xD;
      pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the&#xD;
      patient supine at the end of surgery. Change in the distance will be noted to confirm the&#xD;
      migration of ETT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 19, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.</measure>
    <time_frame>Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.</time_frame>
    <description>proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.</measure>
    <time_frame>Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.</time_frame>
    <description>cricoid cartilage to suprasternal distance changes with the position of neck, so it could affect the distance between the endotracheal tube tip and carina as the position of patient changes during various robotic surgical steps.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Robotic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Three point cuff palpation and Blck mark line technique</arm_group_label>
    <description>In &quot;Three point cuff palpation technique&quot; the cuff will be palpated just below the cricothyroid membrane,at the level of suprasternal notch and below the suprasternal notchand the tube is re-positioned in case of any discrepancy between the black mark line technique and three point cuff at three different over the trachea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Three point cuff palpation technique</intervention_name>
    <description>the ETT is finally positioned according to the Three point cuff technique.</description>
    <arm_group_label>Three point cuff palpation and Blck mark line technique</arm_group_label>
    <other_name>Black line mark on the endotracheal tube</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing the robotic urological or gynecological surgery in Trendelenburg&#xD;
        position with pneumoperitoneum will be included in the study cohort.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Robotic uro-oncological surgical procedures of perineum&#xD;
&#xD;
          -  Robotic gynae-oncological surgical procedures of perineum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper airway fibrosis or tracheal stenosis&#xD;
&#xD;
          -  Large neck swelling distorting or deviating the trachea.&#xD;
&#xD;
          -  Head and neck surgeries&#xD;
&#xD;
          -  Laryngeal and tracheal tumour&#xD;
&#xD;
          -  Tracheal surgery&#xD;
&#xD;
          -  Previous tracheostomy&#xD;
&#xD;
          -  previous radiation treatment of neck&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Kr Mittal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rajiv Gandhi Cancer Institute and Research centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amit Kr Mittal, M.D</last_name>
    <phone>01147022323</phone>
    <phone_ext>2323</phone_ext>
    <email>amitrgci@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mamta Dubey, MD</last_name>
    <phone>09891105744</phone>
    <email>ek_mamta@yahoo.co.in</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rajiv Gandhi Cancer Institute &amp; Research center</name>
      <address>
        <city>Rohini</city>
        <state>New Delhi</state>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amit kr Mittal, M.D</last_name>
      <phone>91-9717611416</phone>
      <email>amitrgci@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Mamta Dubey, M.D</last_name>
      <phone>91-98911105744</phone>
      <email>ek_mamta@yahoo.co.in</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Chang CH, Lee HK, Nam SH. The displacement of the tracheal tube during robot-assisted radical prostatectomy. Eur J Anaesthesiol. 2010 May;27(5):478-80. doi: 10.1097/EJA.0b013e328333d587.</citation>
    <PMID>19918180</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 15, 2018</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rajiv Gandhi Cancer Institute &amp; Research Center, India</investigator_affiliation>
    <investigator_full_name>Amit Kumar Mittal</investigator_full_name>
    <investigator_title>Consultant in-charge</investigator_title>
  </responsible_party>
  <keyword>Endotracheal intubation</keyword>
  <keyword>pneumoperitoneum</keyword>
  <keyword>trendelenburg position</keyword>
  <keyword>Robotic surgery</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04440787
org study id: RES/SCM/30/2018/81
nct id: NCT04440787
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff
      at three sites (just below the cricoid cartilage, at suprasternal level and just below
      suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of
      endotracheal tube and carina. This distance will be measured repeatedly, after
      pneumoperitoneum, after trendelenburg position and after making the patient supine at the end
      of surgery. Change in the distance will be noted.
The endotracheal tube (ETT) will be placed according to the black mark on the tube,
      post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three
      sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT
      cuff position will be scanned by sonography of airway to confirm the position of the proximal
      end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of
      endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after
      pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the
      patient supine at the end of surgery. Change in the distance will be noted to confirm the
      migration of ETT.
observational model: Cohort
time perspective: Prospective
measure: Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.
time frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.
description: proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points.
measure: find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.
time frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.
description: cricoid cartilage to suprasternal distance changes with the position of neck, so it could affect the distance between the endotracheal tube tip and carina as the position of patient changes during various robotic surgical steps.
arm group label: Three point cuff palpation and Blck mark line technique
description: In "Three point cuff palpation technique" the cuff will be palpated just below the cricothyroid membrane,at the level of suprasternal notch and below the suprasternal notchand the tube is re-positioned in case of any discrepancy between the black mark line technique and three point cuff at three different over the trachea.
intervention type: Procedure
intervention name: Three point cuff palpation technique
description: the ETT is finally positioned according to the Three point cuff technique.
arm group label: Three point cuff palpation and Blck mark line technique
other name: Black line mark on the endotracheal tube
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amit Kr Mittal, MD
role: Principal Investigator
affiliation: Rajiv Gandhi Cancer Institute and Research centre
last name: Amit Kr Mittal, M.D
phone: 01147022323
phone ext: 2323
email: amitrgci@gmail.com
last name: Mamta Dubey, MD
phone: 09891105744
email: ek_mamta@yahoo.co.in
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
citation: Chang CH, Lee HK, Nam SH. The displacement of the tracheal tube during robot-assisted radical prostatectomy. Eur J Anaesthesiol. 2010 May;27(5):478-80. doi: 10.1097/EJA.0b013e328333d587.
PMID: 19918180
responsible party type: Principal Investigator
investigator affiliation: Rajiv Gandhi Cancer Institute & Research Center, India
investigator full name: Amit Kumar Mittal
investigator title: Consultant in-charge
sharing ipd: No