<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/NCT03277872</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1144</org_study_id>
    <nct_id>NCT03277872</nct_id>
  </id_info>
  <brief_title>NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope</brief_title>
  <acronym>NoLint</acronym>
  <official_title>NoL Index, Heart Rate and Mean Arterial Blood Pressure Responses to Tracheal Intubation Performed With MacIntosh Blade Versus Glidescope</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ciusss de L'Est de l'Île de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Verathon</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Hospital Specialties Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ciusss de L'Est de l'Île de Montréal</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>
      Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital&#xD;
      and whose objectives are:&#xD;
&#xD;
        -  To observe if the alterations of the NoL index and the standard monitoring (Mean&#xD;
           Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard&#xD;
           monitoring, peak NoL index and peak standard monitoring values, and number of time&#xD;
           passed over their respective threshold for nociceptive response) are more accentuated&#xD;
           after laryngoscopy using the classical MAC blade versus single-use disposable blade of&#xD;
           the Glidescope.&#xD;
&#xD;
        -  To observe the nociceptive response (using the variability of NoL index and standard&#xD;
           monitoring, peak NoL index and peak standard monitoring values, and number of time&#xD;
           passed over their respective threshold for nociceptive response) related to the&#xD;
           insertion of endotracheal tube between vocal cords during the intubation.&#xD;
&#xD;
      Study plans to enroll 50 adult patients scheduled to undergo either general, gynecological,&#xD;
      neurological, orthopedic, plastic or urological surgery under general anesthesia and who&#xD;
      necessitate endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this prospective pragmatic study is to evaluate the changes in NoL index,&#xD;
      Heart Rate (HR) and Mean Arterial Blood Pressure (MABP) following the painful stimulus that&#xD;
      represents laryngoscopy and intubation performed using either the single use blade of the&#xD;
      Glidescope (group GVL) or the classically used MAC blade (group MAC). Calculation will be&#xD;
      using the variations of NoL, HR and MABP, the peak values of these 3 parameters, and also the&#xD;
      area above the curve of each parameter for 3 minutes (above the mean pre-stimulus values) and&#xD;
      the amount of time (out of 3 minutes post-stimulus) those 3 parameters will be significantly&#xD;
      higher than their respective pre-intubation mean thresholds.&#xD;
&#xD;
      In this prospective, randomized and controlled study, each patient will normally enter the&#xD;
      operating room on the day of his surgery. All the normal monitors are installed, along with&#xD;
      the NoL monitor. Pre-oxygenation (with 100% 02) is then started. While the patient is doing&#xD;
      the pre-oxygenation, MABP, HR and NoL index measures are gathered to establish a baseline for&#xD;
      each patient.&#xD;
&#xD;
      Once pre-oxygenation is over, induction with xylocaïne, propofol, remifentanil and rocuronium&#xD;
      is given (according to patients' ideal weight). The end of the remifentanil bolus will&#xD;
      correspond to the time 0 of our study. To be sure our patients are sleeping and on the same&#xD;
      level of anesthetic medication during our study, perfusions of propofol and remifentanil will&#xD;
      be administred until tracheal intubation and inhaled anesthetic gaz given. When the patient&#xD;
      is asleep and apneic, a Guedel device (chosen according to patient weight and height) is&#xD;
      inserted in the mouth, as in usual practice, to ease the manual ventilation until the&#xD;
      laryngoscopy. The patient is then ventilated with a face mask. After 5 minutes, the first&#xD;
      laryngoscopy is performed (either with GlideScope blade or MAC blade according to&#xD;
      randomization). Once a Cormack-Lehane grade I or II is obtained, the movement is ended, and&#xD;
      the patient is ventilated again for 4 minutes with the Guedel. If the procedure takes more&#xD;
      than 30 seconds to perform (if no view of grade I or II is seen before 30 seconds), the&#xD;
      laryngoscopy is considered difficult and the patient will be excluded from the study. At T9&#xD;
      (9 minutes after T0), the second laryngoscopy is done (either with the MacIntosh blade or the&#xD;
      GVL blade - the tool used for the second laryngoscopy will always be the one that wasn't used&#xD;
      at the first laryngoscopy). The size of the MacIntosh blade (MAC 3 or 4) or the disposable&#xD;
      blade for GVL is decided according to the patient size (height and weight). At the second&#xD;
      laryngoscopy, the endotracheal tube is still not inserted, only the procedure of laryngoscopy&#xD;
      is done, so that we can evaluate the hemodynamic and the NoL index responses related only to&#xD;
      the type of device used for laryngoscopy. Then, the operator replaces the Guedel and&#xD;
      ventilates the patient with a facemask (100% O2) for 4 more minutes, without stimulating the&#xD;
      patient otherwise. At T13 (13 minutes after T0), the third laryngoscopy will be performed&#xD;
      (either with the single-use blade for GlideScope or the MacIntosh blade - according to&#xD;
      randomization). This time, the ETT is inserted (size 7 or 8, depending on the size and sex of&#xD;
      the patient). After ETT insertion, the patient is then ventilated with the anesthesia machine&#xD;
      and the perfusions of propofol/remifentanil is discontinued.&#xD;
&#xD;
      Monitors will record HR, MABP and NoL index until 3 minutes after the ETT insertion (end of&#xD;
      the study). All the data will be electronically registered every 5 seconds and exported in an&#xD;
      anonymous manner for each patient into an excel file at the end of the study.&#xD;
&#xD;
      In this study, each patient is exposed to three laryngoscopies; one with the single use blade&#xD;
      for the GlideScope, one with the Macintosh laryngoscopy and one with the ETT insertion&#xD;
      (laryngoscopy done with either GlideScope or Macintosh according to randomization). Hence,&#xD;
      each patient will be its own control. It will then be more reliable to compare the&#xD;
      differences in nociceptive response according to the tool used for laryngoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">July 2, 2021</completion_date>
  <primary_completion_date type="Actual">November 7, 2017</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>
    <intervention_model_description>In this study, each patient will be exposed to three laryngoscopies; one with the single use blade for the GlideScope and without ETT; one with the Macintosh laryngoscopy and without ETT; and one with the ETT insertion (laryngoscopy done with either GlideScope or Macintosh according to second randomization). The order in which will be used either the GlideScope or the MAC blade for the first two laryngoscopies will be decided according to the first randomization.&#xD;
This will lead to 2 different groups for the first randomization process regarding our primary objective:&#xD;
GVL / MAC-DL / GVL or MAC-DL+ETT,&#xD;
MAC-DL / GVL / GVL or MAC-DL+ETT.&#xD;
The tool used for the third laryngoscopy will be decided according to a second randomization, necessary to one of our secondary objectives.&#xD;
Each patient will be its own control when comparing nociceptive response to different laryngoscopy/intubation tool (no need for control group).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delta NoL</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of NoL (delta NoL) after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delta Heart Rate</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta Mean Arterial Blood Pressure</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of NoL</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of NoL after laryngoscopy in the GVL group versus the MAC group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of Heart Rate</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of Mean Arterial Blood Pressure</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time (in seconds) Mean Arterial Blood Pressure is over its baseline value after laryngoscopy stimulus</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the amount of time (in seconds) the MABP will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time (in seconds) NoL, is over its baseline value after laryngoscopy stimulus</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the amount of time (in seconds) the NoL will spend over its respective mean pre-stimulus values after laryngoscopy with GVL versus MAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of time (in seconds) Heart Rate is over its baseline value after laryngoscopy stimulus</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the amount of time (in seconds) the HR will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve for NoL for GVL versus MAC blade</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that NoL spends above its baseline value and calculated for the 3 minutes after the stimulus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve for Heart Rate for GVL versus MAC blade</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that HR spends above its baseline value and calculated for the 3 minutes after the stimulus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve for Mean Arterial Blood Pressure for GVL versus MAC blade</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that MABP spends above its baseline value and calculated for the 3 minutes after the stimulus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of NoL after the laryngoscopy alone versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of HR for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of HR after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variation of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the variation of MABP after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of HR for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak value of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the peak value of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the AUC of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve of HR for laryngoscopy versus laryngoscopy + endotracheal intubation</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the AUC of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation (with both devices)</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the AUC of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta NoL analyzed according to order of randomization to see if this order influences its response</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the influence of the order of the tool used for laryngoscopies with the variation of NoL, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta Heart Rate analyzed according to order of randomization to see if this order influences its response</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the influence of the order of the tool used for laryngoscopies with the variation of HR, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta Mean Arterial Blood Pressure analyzed according to order of randomization to see if this order influences its response</measure>
    <time_frame>From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient</time_frame>
    <description>To compare the influence of the order of the tool used for laryngoscopies with the variation of MABP, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Intubation</condition>
  <condition>Nociceptive Pain</condition>
  <condition>Anesthesia</condition>
  <condition>Laryngoscopy</condition>
  <arm_group>
    <arm_group_label>GlideScope (GVL) Blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will have the first laryngoscopy performed with the GlideScope (GVL) blade and the second one with the MacIntosh blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MacIntosh (MAC) Blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will have the first laryngoscopy performed with the MacIntosh (MAC) blade and the second one with the GlideScope blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngoscopy with GlideScope (GVL) Blade</intervention_name>
    <description>st Laryngoscopy with GVL Blade&#xD;
nd Laryngoscopy with MAC Blade&#xD;
rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization</description>
    <arm_group_label>GlideScope (GVL) Blade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngoscopy with MacIntosh (MAC) Blade</intervention_name>
    <description>st Laryngoscopy with MAC Blade&#xD;
nd Laryngoscopy with GVL Blade&#xD;
rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization</description>
    <arm_group_label>MacIntosh (MAC) Blade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status I or II&#xD;
&#xD;
          -  Mallampati class I or II&#xD;
&#xD;
          -  Patients &gt; 18 years old&#xD;
&#xD;
          -  Elective general, gynecological, neurological, orthopedic, plastic or urological&#xD;
             surgery under general anesthesia&#xD;
&#xD;
          -  Type of surgery that usually necessitate endotracheal intubation and controlled&#xD;
             ventilation&#xD;
&#xD;
        Non-inlusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  History of psychiatric diseases or psychological problems (including mental&#xD;
             retardation); inability to give consent; language barrier.&#xD;
&#xD;
          -  Anticipated difficult airway (Mallampati class III and IV, thyromental distance &lt; 6&#xD;
             cm, mouth opening &lt; 3 cm, neck extension &lt;80° and neck flexion &lt;35°, inability to&#xD;
             prognath, meaning bringing lower mandibular before the upper maxilla)&#xD;
&#xD;
          -  Patient with history of neck rigidity or instability&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Patient with beard (because of recognized risk for difficult ventilation)&#xD;
&#xD;
          -  Patient with history of oropharyngeal or tracheal surgery (excluding adenoidectomy,&#xD;
             amygdalectomy and teeth removal)&#xD;
&#xD;
          -  Severe coronary artery disease&#xD;
&#xD;
          -  Serious cardiac arrhythmias (including atrial fibrillation)&#xD;
&#xD;
          -  Use of β-blockers (all types)&#xD;
&#xD;
          -  History of opioid or illicit drug substance abuse&#xD;
&#xD;
          -  Chronic use of psychotropic and/or opioid drugs&#xD;
&#xD;
          -  Allergy to remifentanil or propofol&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindications to mask ventilation (GI tract obstruction, pregnancy, active GERD,&#xD;
             non-fasting patients)&#xD;
&#xD;
          -  Difficult mask ventilation (before randomization at the first laryngoscopy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unexpected difficult airway requesting excessive, possibly painful airway&#xD;
             manipulations&#xD;
&#xD;
          -  Requiring hemodynamic support with vasopressors or inotropes 5 minutes before first&#xD;
             laryngoscopy to 3 minutes after insertion of ETT&#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>Philippe Richebe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal</name>
      <address>
        <city>Montréal-Est</city>
        <state>Quebec</state>
        <zip>H1T2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ciusss de L'Est de l'Île de Montréal</investigator_affiliation>
    <investigator_full_name>Philippe Richebe</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nociceptive Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyrithione zinc</mesh_term>
  </intervention_browse>
  <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/NCT03277872
org study id: 2018-1144
nct id: NCT03277872
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, randomized and controlled who will be conducted in Maisonneuve-Rosemont hospital
      and whose objectives are:

        -  To observe if the alterations of the NoL index and the standard monitoring (Mean
           Arterial Blood Pressure and Heart Rate) (using the variability of NoL index and standard
           monitoring, peak NoL index and peak standard monitoring values, and number of time
           passed over their respective threshold for nociceptive response) are more accentuated
           after laryngoscopy using the classical MAC blade versus single-use disposable blade of
           the Glidescope.

        -  To observe the nociceptive response (using the variability of NoL index and standard
           monitoring, peak NoL index and peak standard monitoring values, and number of time
           passed over their respective threshold for nociceptive response) related to the
           insertion of endotracheal tube between vocal cords during the intubation.

      Study plans to enroll 50 adult patients scheduled to undergo either general, gynecological,
      neurological, orthopedic, plastic or urological surgery under general anesthesia and who
      necessitate endotracheal intubation.
The purpose of this prospective pragmatic study is to evaluate the changes in NoL index,
      Heart Rate (HR) and Mean Arterial Blood Pressure (MABP) following the painful stimulus that
      represents laryngoscopy and intubation performed using either the single use blade of the
      Glidescope (group GVL) or the classically used MAC blade (group MAC). Calculation will be
      using the variations of NoL, HR and MABP, the peak values of these 3 parameters, and also the
      area above the curve of each parameter for 3 minutes (above the mean pre-stimulus values) and
      the amount of time (out of 3 minutes post-stimulus) those 3 parameters will be significantly
      higher than their respective pre-intubation mean thresholds.

      In this prospective, randomized and controlled study, each patient will normally enter the
      operating room on the day of his surgery. All the normal monitors are installed, along with
      the NoL monitor. Pre-oxygenation (with 100% 02) is then started. While the patient is doing
      the pre-oxygenation, MABP, HR and NoL index measures are gathered to establish a baseline for
      each patient.

      Once pre-oxygenation is over, induction with xylocaïne, propofol, remifentanil and rocuronium
      is given (according to patients' ideal weight). The end of the remifentanil bolus will
      correspond to the time 0 of our study. To be sure our patients are sleeping and on the same
      level of anesthetic medication during our study, perfusions of propofol and remifentanil will
      be administred until tracheal intubation and inhaled anesthetic gaz given. When the patient
      is asleep and apneic, a Guedel device (chosen according to patient weight and height) is
      inserted in the mouth, as in usual practice, to ease the manual ventilation until the
      laryngoscopy. The patient is then ventilated with a face mask. After 5 minutes, the first
      laryngoscopy is performed (either with GlideScope blade or MAC blade according to
      randomization). Once a Cormack-Lehane grade I or II is obtained, the movement is ended, and
      the patient is ventilated again for 4 minutes with the Guedel. If the procedure takes more
      than 30 seconds to perform (if no view of grade I or II is seen before 30 seconds), the
      laryngoscopy is considered difficult and the patient will be excluded from the study. At T9
      (9 minutes after T0), the second laryngoscopy is done (either with the MacIntosh blade or the
      GVL blade - the tool used for the second laryngoscopy will always be the one that wasn't used
      at the first laryngoscopy). The size of the MacIntosh blade (MAC 3 or 4) or the disposable
      blade for GVL is decided according to the patient size (height and weight). At the second
      laryngoscopy, the endotracheal tube is still not inserted, only the procedure of laryngoscopy
      is done, so that we can evaluate the hemodynamic and the NoL index responses related only to
      the type of device used for laryngoscopy. Then, the operator replaces the Guedel and
      ventilates the patient with a facemask (100% O2) for 4 more minutes, without stimulating the
      patient otherwise. At T13 (13 minutes after T0), the third laryngoscopy will be performed
      (either with the single-use blade for GlideScope or the MacIntosh blade - according to
      randomization). This time, the ETT is inserted (size 7 or 8, depending on the size and sex of
      the patient). After ETT insertion, the patient is then ventilated with the anesthesia machine
      and the perfusions of propofol/remifentanil is discontinued.

      Monitors will record HR, MABP and NoL index until 3 minutes after the ETT insertion (end of
      the study). All the data will be electronically registered every 5 seconds and exported in an
      anonymous manner for each patient into an excel file at the end of the study.

      In this study, each patient is exposed to three laryngoscopies; one with the single use blade
      for the GlideScope, one with the Macintosh laryngoscopy and one with the ETT insertion
      (laryngoscopy done with either GlideScope or Macintosh according to randomization). Hence,
      each patient will be its own control. It will then be more reliable to compare the
      differences in nociceptive response according to the tool used for laryngoscopy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, each patient will be exposed to three laryngoscopies; one with the single use blade for the GlideScope and without ETT; one with the Macintosh laryngoscopy and without ETT; and one with the ETT insertion (laryngoscopy done with either GlideScope or Macintosh according to second randomization). The order in which will be used either the GlideScope or the MAC blade for the first two laryngoscopies will be decided according to the first randomization.
This will lead to 2 different groups for the first randomization process regarding our primary objective:
GVL / MAC-DL / GVL or MAC-DL+ETT,
MAC-DL / GVL / GVL or MAC-DL+ETT.
The tool used for the third laryngoscopy will be decided according to a second randomization, necessary to one of our secondary objectives.
Each patient will be its own control when comparing nociceptive response to different laryngoscopy/intubation tool (no need for control group).
primary purpose: Other
masking: None (Open Label)
measure: Delta NoL
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of NoL (delta NoL) after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
measure: Delta Heart Rate
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
measure: Delta Mean Arterial Blood Pressure
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of the standard hemodynamic parameter after laryngoscopy using the single use blade for Glidescope (GVL) versus MAC blade (MAC) in anesthetized patients
measure: Peak value of NoL
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of NoL after laryngoscopy in the GVL group versus the MAC group
measure: Peak value of Heart Rate
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group
measure: Peak value of Mean Arterial Blood Pressure
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of standard hemodynamic parameter after laryngoscopy in the GVL group versus the MAC group
measure: Amount of time (in seconds) Mean Arterial Blood Pressure is over its baseline value after laryngoscopy stimulus
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the amount of time (in seconds) the MABP will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC
measure: Amount of time (in seconds) NoL, is over its baseline value after laryngoscopy stimulus
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the amount of time (in seconds) the NoL will spend over its respective mean pre-stimulus values after laryngoscopy with GVL versus MAC
measure: Amount of time (in seconds) Heart Rate is over its baseline value after laryngoscopy stimulus
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the amount of time (in seconds) the HR will spend over its respective mean pre-stimulus value after laryngoscopy with GVL versus MAC
measure: Area Under the Curve for NoL for GVL versus MAC blade
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that NoL spends above its baseline value and calculated for the 3 minutes after the stimulus
measure: Area Under the Curve for Heart Rate for GVL versus MAC blade
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that HR spends above its baseline value and calculated for the 3 minutes after the stimulus
measure: Area Under the Curve for Mean Arterial Blood Pressure for GVL versus MAC blade
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the area under the curve between GVL versus MAC-Dl laryngoscopy that MABP spends above its baseline value and calculated for the 3 minutes after the stimulus
measure: Variation of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of NoL after the laryngoscopy alone versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Variation of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of HR after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Variation of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the variation of MABP after the laryngoscopy versus laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Peak value of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Peak value of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Peak value of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the peak value of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Area Under the Curve of NoL for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the AUC of NoL after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Area Under the Curve of HR for laryngoscopy versus laryngoscopy + endotracheal intubation
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the AUC of HR after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Area Under the Curve of MABP for laryngoscopy versus laryngoscopy + endotracheal intubation (with both devices)
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the AUC of MABP after the laryngoscopy + endotracheal tube (ETT) insertion in the GVL and the Mac group
measure: Delta NoL analyzed according to order of randomization to see if this order influences its response
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the influence of the order of the tool used for laryngoscopies with the variation of NoL, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
measure: Delta Heart Rate analyzed according to order of randomization to see if this order influences its response
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the influence of the order of the tool used for laryngoscopies with the variation of HR, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
measure: Delta Mean Arterial Blood Pressure analyzed according to order of randomization to see if this order influences its response
time frame: From 30 seconds before to 3 minutes after each laryngoscopy (3 total) for each patient
description: To compare the influence of the order of the tool used for laryngoscopies with the variation of MABP, after laryngoscopy using the single use blade for Glidescope (GVL) and MAC blade (MAC) in anesthetized patients
arm group label: GlideScope (GVL) Blade
arm group type: Active Comparator
description: Patients in this arm will have the first laryngoscopy performed with the GlideScope (GVL) blade and the second one with the MacIntosh blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.
arm group label: MacIntosh (MAC) Blade
arm group type: Active Comparator
description: Patients in this arm will have the first laryngoscopy performed with the MacIntosh (MAC) blade and the second one with the GlideScope blade. The tool used for the third laryngoscopy, followed by intubation, (either GlideScope or MAC blade) will be decided according to a second randomization, necessary to one of our secondary objectives.
intervention type: Device
intervention name: Laryngoscopy with GlideScope (GVL) Blade
description: st Laryngoscopy with GVL Blade
nd Laryngoscopy with MAC Blade
rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
arm group label: GlideScope (GVL) Blade
intervention type: Device
intervention name: Laryngoscopy with MacIntosh (MAC) Blade
description: st Laryngoscopy with MAC Blade
nd Laryngoscopy with GVL Blade
rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization
arm group label: MacIntosh (MAC) Blade
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Richebe, MD, PhD
role: Principal Investigator
affiliation: Université de Montréal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Ciusss de L'Est de l'Île de Montréal
investigator full name: Philippe Richebe
investigator title: Principal Investigator
mesh term: Nociceptive Pain
mesh term: Pyrithione zinc
sharing ipd: No