<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/NCT04449770</url>
  </required_header>
  <id_info>
    <org_study_id>E-18-3064/IRB 06.05.2018</org_study_id>
    <nct_id>NCT04449770</nct_id>
  </id_info>
  <brief_title>Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy</brief_title>
  <official_title>A Study on the Use of an Established Novel Height-based Formula for Predicting the Insertion Depth of Left-sided Double and the Role of Fiberoptic Bronchoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>No</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>
      The use of height based formula to predict insertion depth of left-sided double lumen tube in&#xD;
      thoracic surgery is now well established. The investigators have developed a formula to be&#xD;
      used and published recently. The investigators verified the formula with the use of FOB. This&#xD;
      observational study we are going to use with FOB checking if needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of a height-based formula to predict the insertion depth of left-sided double-lumen&#xD;
      tubes in thoracic surgery is now well established. The investigators have developed a formula&#xD;
      to be used and published recently. The investigators verified the formula with the use of&#xD;
      FOB. This observational study will use FOB checking if needed.&#xD;
&#xD;
      Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That&#xD;
      doesn't mean FOB is less required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>correct position of DLT with proper lung deflation without use of FOB</measure>
    <time_frame>during surgical time</time_frame>
    <description>proper lung deflation, surgeon satisfaction</description>
  </primary_outcome>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Thoracic Anesthesia</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>double lumen tube</intervention_name>
    <description>prospective cohort study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients aged 20-60 yr undergoing thoracic surgery with the use of left-sided DLT for&#xD;
        lung isolation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients whose procedure required placement of an LDLT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with intraluminal bronchial lesions and patients with a difficult airway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>abdelazeem eldawlatly</last_name>
    <phone>00966503261042</phone>
    <email>dawlatly2@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>King Saud University</name>
      <address>
        <city>Riyadh</city>
        <zip>11462</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>abdelazeem eldawlatly</last_name>
      <phone>966503261042</phone>
      <phone_ext>966503261042</phone_ext>
      <email>dawlatly2@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>A.Eldawlatly</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Thoracic anesthesia</keyword>
  <keyword>Double lumen tube</keyword>
  <keyword>Height based formula</keyword>
  <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/NCT04449770
org study id: E-18-3064/IRB 06.05.2018
nct id: NCT04449770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of height based formula to predict insertion depth of left-sided double lumen tube in
      thoracic surgery is now well established. The investigators have developed a formula to be
      used and published recently. The investigators verified the formula with the use of FOB. This
      observational study we are going to use with FOB checking if needed.
The use of a height-based formula to predict the insertion depth of left-sided double-lumen
      tubes in thoracic surgery is now well established. The investigators have developed a formula
      to be used and published recently. The investigators verified the formula with the use of
      FOB. This observational study will use FOB checking if needed.

      Our hypothesis is that DLT can insert without the use of FOB in most of the cases. That
      doesn't mean FOB is less required.
observational model: Cohort
time perspective: Prospective
measure: correct position of DLT with proper lung deflation without use of FOB
time frame: during surgical time
description: proper lung deflation, surgeon satisfaction
intervention type: Device
intervention name: double lumen tube
description: prospective cohort study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: abdelazeem eldawlatly
phone: 00966503261042
email: dawlatly2@yahoo.com
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: A.Eldawlatly
investigator title: professor
sharing ipd: Undecided