<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/NCT02983149</url>
  </required_header>
  <id_info>
    <org_study_id>14-7478-A</org_study_id>
    <nct_id>NCT02983149</nct_id>
  </id_info>
  <brief_title>A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation</brief_title>
  <official_title>A Clinical Comparison of Two New Bronchial Blockers vs. Double Lumen Tubes in One Lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing thoracic surgery require selective ventilation of one lung, which allows&#xD;
      surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung&#xD;
      ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the&#xD;
      placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are&#xD;
      in routine clinical use at University Health Network.&#xD;
&#xD;
      Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design&#xD;
      and two balloons, one of which is designed to fall into each of the right and left sides, it&#xD;
      may require less repositioning. Initial clinical experience with the EZ Blocker suggests that&#xD;
      it may be less likely than other blockers to become malpositioned during surgery.&#xD;
&#xD;
      This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker&#xD;
      at this institution, and to double-lumen tubes, the most commonly used devices to provide&#xD;
      lung isolation, with respect to intra-operative malpositioning and the speed of lung&#xD;
      separation and efficacy of lung collapse during thoracic surgery.&#xD;
&#xD;
      Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or&#xD;
      left-sided DLT, immediately prior to induction of anesthesia.&#xD;
&#xD;
      The primary end points of time to lung isolation and number of required repositioning&#xD;
      maneuvers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STUDY END POINTS The time required to achieve lung separation, from beginning of laryngoscopy&#xD;
      to lung isolation (inflation of the bronchial cuff or blocker), will be recorded. The&#xD;
      thoracic surgeons, using a verbal analogue scale, will assess the lung collapse(lung collapse&#xD;
      scores-LCS, 0=no collapse, to 10=complete collapse). The LCS will be assessed and recorded as&#xD;
      they open the pleura during the procedure (LCS 0), and at 10 min., (LCS 10), and 20 min. (LCS&#xD;
      20) after opening the pleura. The surgeons will be blinded to the lung isolation device used&#xD;
      in the patient. If the lung collapse is not satisfactory, the FOB will be passed to assess&#xD;
      the lung isolation, and if necessary reposition the device. A malposition will be defined as&#xD;
      a clinically obvious relocation of the devise in the trachea or bronchus and a loss of lung&#xD;
      isolation interfering with surgery. The number of repositions of the lung isolation device&#xD;
      after initial supine placement, airway pressures, tidal volumes, duration of surgery, and the&#xD;
      arterial blood gases 20 minutes after pleural opening will be noted.&#xD;
&#xD;
      In addition to the primary end points of time to lung isolation and number of required&#xD;
      repositioning maneuvers, the following variables will be recorded: Age, gender, weight,&#xD;
      height, BMI, ASA, airway Mallampati score, pulmonary spirometry (if clinically performed:&#xD;
      TLC, FEV1, FVC, DLCO), LCS 0/10/20, ventilatory parameters on OLV (airway pressure, tidal&#xD;
      volume, respiratory rate, compliance, duration of OLV and surgery, arterial blood gas 20&#xD;
      minutes after opening the pleura (pH, paO2, pCO2 bicarbonate, base excess, oxygen&#xD;
      saturation), and finally the dimensions of the left main bronchus (LMB) and the right main&#xD;
      bronchus (RMB) using the on-screen program of the radiology server on the pre-operative chest&#xD;
      imaging, by the anesthesiologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2015</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time required for lung separation</measure>
    <time_frame>From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)</time_frame>
    <description>The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of repositioning maneuvers of the device</measure>
    <time_frame>After initial patient's supine position for the duration of the operation 0-3 hours will be recorded</time_frame>
    <description>The number of repositions of the lung isolation device after initial supine placement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung collapse scores</measure>
    <time_frame>The thoracic surgeons, using a verbal analogue scale, will be assessing the lung collapse score (LCS), from 0=no collapse to 10=complete collapse. LCS will be assessed just after opening the pleura, at 10 min., and 20 min. after opening the pleura.</time_frame>
    <description>Time Frame: After opening the pleura, the lung collapse scores will be measured at 0, 10 and 20 minutes (from pleura opening)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Thoracic Surgery, Lung Isolation</condition>
  <arm_group>
    <arm_group_label>Double lumen tube</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One lung ventilation will be achieved using a double lumen tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fuji blocker</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One lung ventilation will be achieved using the Fuji blocker</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EZ blocker</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One lung ventilation will be achieved using the EZ blocker</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double lumen tube</intervention_name>
    <description>Use an double lumen tube to achieve one lung ventilation in thoracic surgeries</description>
    <arm_group_label>Double lumen tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fuji blocker</intervention_name>
    <description>Use the Fuji blocker to achieve one lung ventilation in thoracic surgeries</description>
    <arm_group_label>Fuji blocker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EZ blocker</intervention_name>
    <description>Use the EZ blocker to achieve one lung ventilation in thoracic surgeries</description>
    <arm_group_label>EZ blocker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  Thoracic surgery requiring one-lung ventilation for &gt; 30 minutes.&#xD;
&#xD;
          -  Able to provide first party consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known prior difficult intubation.&#xD;
&#xD;
          -  Upper airway exam suggestive of difficult intubation.&#xD;
&#xD;
          -  Surgical procedure requiring a right double lumen endotracheal tube (such as left&#xD;
             pneumonectomy).&#xD;
&#xD;
          -  Evidence on clinically required radiologic imaging of abnormal lower airway anatomy,&#xD;
             such as right upper lobe origin of the bronchus.&#xD;
&#xD;
          -  Prior thoracic surgery or pleurodesis of the operative side (would delay lung&#xD;
             collapse).&#xD;
&#xD;
          -  History of severe restrictive lung disease (such as pulmonary fibrosis or emphysema)&#xD;
             which may affect inflation/deflation times.&#xD;
&#xD;
          -  Trauma patients requiring video-assisted thoracoscopic surgery&#xD;
&#xD;
          -  Has condition(s) that contraindicate a double lumen endotracheal tube (DLT) or the&#xD;
             placement of a bronchial blocker (BB) via a single lumen endotracheal tube.&#xD;
&#xD;
          -  Patients with communication difficulties.&#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>Peter Slinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto General Hospital, University Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto General Hospital, 200 Elizabeth St.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>April 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Jo Carroll</investigator_full_name>
    <investigator_title>Manager Anesthesia Research</investigator_title>
  </responsible_party>
  <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/NCT02983149
org study id: 14-7478-A
nct id: NCT02983149
lead sponsor: 
has dmc: No
Patients undergoing thoracic surgery require selective ventilation of one lung, which allows
      surgery to proceed on the operative lung that is deflated, and no longer moving. One-lung
      ventilation (OLV) may be achieved by the use of a double lumen endotracheal tube (DLT) or the
      placement of a bronchial blocker (BB) via a single lumen endotracheal tube, both of which are
      in routine clinical use at University Health Network.

      Recently, the Endobronchial Blocker (EZ blocker) has been marketed, with a forked tip design
      and two balloons, one of which is designed to fall into each of the right and left sides, it
      may require less repositioning. Initial clinical experience with the EZ Blocker suggests that
      it may be less likely than other blockers to become malpositioned during surgery.

      This study will compare the EZ blocker to the Fuji blocker, the most frequently used blocker
      at this institution, and to double-lumen tubes, the most commonly used devices to provide
      lung isolation, with respect to intra-operative malpositioning and the speed of lung
      separation and efficacy of lung collapse during thoracic surgery.

      Patients will be randomly assigned, to one of the three study groups: EZ Blocker, Fuji, or
      left-sided DLT, immediately prior to induction of anesthesia.

      The primary end points of time to lung isolation and number of required repositioning
      maneuvers.
STUDY END POINTS The time required to achieve lung separation, from beginning of laryngoscopy
      to lung isolation (inflation of the bronchial cuff or blocker), will be recorded. The
      thoracic surgeons, using a verbal analogue scale, will assess the lung collapse(lung collapse
      scores-LCS, 0=no collapse, to 10=complete collapse). The LCS will be assessed and recorded as
      they open the pleura during the procedure (LCS 0), and at 10 min., (LCS 10), and 20 min. (LCS
      20) after opening the pleura. The surgeons will be blinded to the lung isolation device used
      in the patient. If the lung collapse is not satisfactory, the FOB will be passed to assess
      the lung isolation, and if necessary reposition the device. A malposition will be defined as
      a clinically obvious relocation of the devise in the trachea or bronchus and a loss of lung
      isolation interfering with surgery. The number of repositions of the lung isolation device
      after initial supine placement, airway pressures, tidal volumes, duration of surgery, and the
      arterial blood gases 20 minutes after pleural opening will be noted.

      In addition to the primary end points of time to lung isolation and number of required
      repositioning maneuvers, the following variables will be recorded: Age, gender, weight,
      height, BMI, ASA, airway Mallampati score, pulmonary spirometry (if clinically performed:
      TLC, FEV1, FVC, DLCO), LCS 0/10/20, ventilatory parameters on OLV (airway pressure, tidal
      volume, respiratory rate, compliance, duration of OLV and surgery, arterial blood gas 20
      minutes after opening the pleura (pH, paO2, pCO2 bicarbonate, base excess, oxygen
      saturation), and finally the dimensions of the left main bronchus (LMB) and the right main
      bronchus (RMB) using the on-screen program of the radiology server on the pre-operative chest
      imaging, by the anesthesiologist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time required for lung separation
time frame: From initial laryngoscopy to lung isolation will be measured for 0 hours (procedure start) to 3 hours (procedure end time)
description: The time required to achieve lung separation, from beginning of laryngoscopy to lung isolation.
measure: Number of repositioning maneuvers of the device
time frame: After initial patient's supine position for the duration of the operation 0-3 hours will be recorded
description: The number of repositions of the lung isolation device after initial supine placement
measure: Lung collapse scores
time frame: The thoracic surgeons, using a verbal analogue scale, will be assessing the lung collapse score (LCS), from 0=no collapse to 10=complete collapse. LCS will be assessed just after opening the pleura, at 10 min., and 20 min. after opening the pleura.
description: Time Frame: After opening the pleura, the lung collapse scores will be measured at 0, 10 and 20 minutes (from pleura opening)
arm group label: Double lumen tube
arm group type: Other
description: One lung ventilation will be achieved using a double lumen tube
arm group label: Fuji blocker
arm group type: Other
description: One lung ventilation will be achieved using the Fuji blocker
arm group label: EZ blocker
arm group type: Other
description: One lung ventilation will be achieved using the EZ blocker
intervention type: Device
intervention name: Double lumen tube
description: Use an double lumen tube to achieve one lung ventilation in thoracic surgeries
arm group label: Double lumen tube
intervention type: Device
intervention name: Fuji blocker
description: Use the Fuji blocker to achieve one lung ventilation in thoracic surgeries
arm group label: Fuji blocker
intervention type: Device
intervention name: EZ blocker
description: Use the EZ blocker to achieve one lung ventilation in thoracic surgeries
arm group label: EZ blocker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Slinger, MD
role: Principal Investigator
affiliation: Toronto General Hospital, University Health Network
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Jo Carroll
investigator title: Manager Anesthesia Research
sharing ipd: No