<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/NCT04433884</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3278-9046</org_study_id>
    <nct_id>NCT04433884</nct_id>
  </id_info>
  <brief_title>Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery</brief_title>
  <official_title>Evaluation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation Using Conventional Laryngoscope Versus C-MAC Video Laryngoscope in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG) Surgery - A Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to compare hemodynamic response upon endotracheal intubation using&#xD;
      either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in&#xD;
      patients undergoing elective coronary artery bypass grafting without anticipated difficult&#xD;
      airway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be premeditated with 7.5mg oral midazolam approximately 45-60 minutes prior to&#xD;
      anesthesia. The standard monitoring of Electrocardiography for ST analysis and SPO2 will be&#xD;
      monitored continuously. Capnography, tidal volume and airway pressure will also be monitored&#xD;
      during anesthesia. Arterial line for invasive Blood Pressure monitoring, wide bore IV cannula&#xD;
      will be placed before induction of anesthesia. Anesthesia technique will be standardized in&#xD;
      both groups. After pre-oxygenation, anesthesia co-induction will be done with midazolam&#xD;
      0.02-0.05 mg/kg, propofol 0.5-1mg/kg and fentanyl 5mcg/kg. Cis-atracurium 0.15mg/kg will be&#xD;
      used as muscle relaxant. Patient will be ventilated manually by using isoflurane (1% end&#xD;
      tidal) in oxygen using facemask. ETT will be placed orally via direct laryngoscopy by MC and&#xD;
      C-MAC blade 3 or 4 when a Train of Four would not be achieved. All intubation will be&#xD;
      performed by senior experienced anesthetist having experience of at least 20 intubations&#xD;
      using video laryngoscope.&#xD;
&#xD;
      After induction a central venous catheter will be placed for central venous pressure&#xD;
      monitoring and a thermo dilution Swan Ganz catheter will be inserted if indicated.&#xD;
&#xD;
      Tracheal intubation will be performed using the standard Macintosh laryngoscope(MC) or C- MAC&#xD;
      video laryngoscope (VL) (Karl Storz, Tuttlingen, Germany).&#xD;
&#xD;
      Hemodynamic changes, laryngoscopic view, the number of attempts, the time required for&#xD;
      laryngoscopy and tracheal intubation, changes in rhythm, and intraoperative and post&#xD;
      operative complications will be recorded. Heart rate (HR), systolic arterial pressure (SAP),&#xD;
      diastolic arterial pressure (DAP) and mean arterial pressure (MAP) along with peripheral&#xD;
      oxygen saturation (SpO2), will be recorded before (T1) and after induction (T2), 1 minute&#xD;
      after intubation (T3), 5 min (T4) and 10 min (T5)post intubation. End tidal carbon dioxide&#xD;
      (EtCO2) will be recorded immediately after induction (T2), immediately after intubation 1&#xD;
      minute (T3), 5 min (T4) and 10 min (T5) post intubation. Measurements obtained after&#xD;
      induction of anesthesia when the hemodynamics will be stable (post induction) will be&#xD;
      considered as baseline measurements in the study.&#xD;
&#xD;
      Duration of laryngoscopy (DOL) is defined as the time from oral placement of the laryngoscope&#xD;
      blade to obtaining the best glottic view. For the evaluation of glottic view during&#xD;
      laryngoscopy, modified Cormack and Lehane Scoring System (m CL) and percentage of the glottis&#xD;
      opening (POGO) score will be used. Duration of intubation (DOI) is defined as the time&#xD;
      interval between oral placement of the ET to the attainment of tracing of 3 EtCO2 waveforms&#xD;
      after intubation and initiation of mechanical ventilation. An attempt is defined as the time&#xD;
      from introduction of laryngoscope into the oral cavity until its removal. Three attempts at&#xD;
      intubation will be allowed for all groups. Failure to intubate will be defined as the&#xD;
      inability to intubate after three attempts. An alternative technique will be used in cases of&#xD;
      failure as per the discretion of anesthetist. In the case of multiple attempts, the duration&#xD;
      of each attempt will be recorded. The duration of laryngoscopy and intubation (DOLI) is&#xD;
      defined as the sum of all intubation attempts. The hemodynamic changes after intubation will&#xD;
      be evaluated after successful intubation. After the study period, the anesthetic agents will&#xD;
      be used as per the patient requirement. A number of unsuccessful attempts of intubation,&#xD;
      complications encountered during intubation (bleeding, lacerations, dental injury, etc.,),&#xD;
      and optimal laryngeal external manipulation (OLEM) during intubation will be recorded. The&#xD;
      management of these complications will be done by primary anaesthesia team as per their&#xD;
      feasibility and the costs of management of these complications will be covered under hospital&#xD;
      insurance. Difficult intubation will be assessed by using Intubation Difficulty score (Table&#xD;
      1), Thyromental distance and Upper lip bite test.&#xD;
&#xD;
      Adverse effects of A number unsuccessful attempts of intubation, complications encountered&#xD;
      during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal&#xD;
      external manipulation (OLEM) during intubation will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 7, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Computer generated randomization using envelopes</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in blood pressure (in millimeters of Hg)</measure>
    <time_frame>Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation</time_frame>
    <description>Hemodynamic response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in heart rate (beats per minute)</measure>
    <time_frame>Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation</time_frame>
    <description>Hemodynamic response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arrhythmias</measure>
    <time_frame>Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation</time_frame>
    <description>Presence of arrhythmias would be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative myocardial ischemia</measure>
    <time_frame>Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation</time_frame>
    <description>Presence of myocardial ischemia would be noted by ST segment changes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>Conventional MAC Laryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will undergo intubation using conventional macintosh laryngoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-MAC Video laryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will undergo intubation using video C-Mac laryngoscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endotracheal intubation using a laryngoscope</intervention_name>
    <description>Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded</description>
    <arm_group_label>C-MAC Video laryngoscope</arm_group_label>
    <arm_group_label>Conventional MAC Laryngoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 35-65&#xD;
&#xD;
          -  Elective Coronary Artery By Pass Grafting&#xD;
&#xD;
          -  American Society Of Anesthesiologist III/IV&#xD;
&#xD;
          -  Unanticipated difficult airway&#xD;
&#xD;
          -  Mallampati I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obese Body Mass Index &gt; 35kg/m2&#xD;
&#xD;
          -  Left Main Coronary Artery critical Disease&#xD;
&#xD;
          -  Recent MI or unstable Angina&#xD;
&#xD;
          -  Left heart failure/ Left ventricular ejection fraction&lt;35%&#xD;
&#xD;
          -  Upper lip bite test class III&#xD;
&#xD;
          -  Thyromental distance &lt;6.0 cm&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Anticipated difficult airway&#xD;
&#xD;
          -  Respiratory Diseases&#xD;
&#xD;
          -  Bleeding diathesis&#xD;
&#xD;
          -  Neurological deficit&#xD;
&#xD;
          -  Limited nuchal Range of motion&#xD;
&#xD;
          -  Gastro Esophageal Reflux Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sehrish Khan, MBBS</last_name>
    <phone>923347126366</phone>
    <email>sehrish.khan@aku.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Khalid Samad, MBBS,FCPS(Anesthesiology)</last_name>
    <phone>923343311603</phone>
    <email>khalid.samad@aku.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anesthesiology</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khalid Samad, MBBS,FCPS(Anesthesiology)</last_name>
      <phone>923343311603</phone>
      <email>khalid.samad@aku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Sehrish khan</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <!-- 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/NCT04433884
org study id: 2020-3278-9046
nct id: NCT04433884
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is being done to compare hemodynamic response upon endotracheal intubation using
      either conventional laryngoscopy with Macintosh blade versus C-Mac video laryngoscope in
      patients undergoing elective coronary artery bypass grafting without anticipated difficult
      airway.
Patients will be premeditated with 7.5mg oral midazolam approximately 45-60 minutes prior to
      anesthesia. The standard monitoring of Electrocardiography for ST analysis and SPO2 will be
      monitored continuously. Capnography, tidal volume and airway pressure will also be monitored
      during anesthesia. Arterial line for invasive Blood Pressure monitoring, wide bore IV cannula
      will be placed before induction of anesthesia. Anesthesia technique will be standardized in
      both groups. After pre-oxygenation, anesthesia co-induction will be done with midazolam
      0.02-0.05 mg/kg, propofol 0.5-1mg/kg and fentanyl 5mcg/kg. Cis-atracurium 0.15mg/kg will be
      used as muscle relaxant. Patient will be ventilated manually by using isoflurane (1% end
      tidal) in oxygen using facemask. ETT will be placed orally via direct laryngoscopy by MC and
      C-MAC blade 3 or 4 when a Train of Four would not be achieved. All intubation will be
      performed by senior experienced anesthetist having experience of at least 20 intubations
      using video laryngoscope.

      After induction a central venous catheter will be placed for central venous pressure
      monitoring and a thermo dilution Swan Ganz catheter will be inserted if indicated.

      Tracheal intubation will be performed using the standard Macintosh laryngoscope(MC) or C- MAC
      video laryngoscope (VL) (Karl Storz, Tuttlingen, Germany).

      Hemodynamic changes, laryngoscopic view, the number of attempts, the time required for
      laryngoscopy and tracheal intubation, changes in rhythm, and intraoperative and post
      operative complications will be recorded. Heart rate (HR), systolic arterial pressure (SAP),
      diastolic arterial pressure (DAP) and mean arterial pressure (MAP) along with peripheral
      oxygen saturation (SpO2), will be recorded before (T1) and after induction (T2), 1 minute
      after intubation (T3), 5 min (T4) and 10 min (T5)post intubation. End tidal carbon dioxide
      (EtCO2) will be recorded immediately after induction (T2), immediately after intubation 1
      minute (T3), 5 min (T4) and 10 min (T5) post intubation. Measurements obtained after
      induction of anesthesia when the hemodynamics will be stable (post induction) will be
      considered as baseline measurements in the study.

      Duration of laryngoscopy (DOL) is defined as the time from oral placement of the laryngoscope
      blade to obtaining the best glottic view. For the evaluation of glottic view during
      laryngoscopy, modified Cormack and Lehane Scoring System (m CL) and percentage of the glottis
      opening (POGO) score will be used. Duration of intubation (DOI) is defined as the time
      interval between oral placement of the ET to the attainment of tracing of 3 EtCO2 waveforms
      after intubation and initiation of mechanical ventilation. An attempt is defined as the time
      from introduction of laryngoscope into the oral cavity until its removal. Three attempts at
      intubation will be allowed for all groups. Failure to intubate will be defined as the
      inability to intubate after three attempts. An alternative technique will be used in cases of
      failure as per the discretion of anesthetist. In the case of multiple attempts, the duration
      of each attempt will be recorded. The duration of laryngoscopy and intubation (DOLI) is
      defined as the sum of all intubation attempts. The hemodynamic changes after intubation will
      be evaluated after successful intubation. After the study period, the anesthetic agents will
      be used as per the patient requirement. A number of unsuccessful attempts of intubation,
      complications encountered during intubation (bleeding, lacerations, dental injury, etc.,),
      and optimal laryngeal external manipulation (OLEM) during intubation will be recorded. The
      management of these complications will be done by primary anaesthesia team as per their
      feasibility and the costs of management of these complications will be covered under hospital
      insurance. Difficult intubation will be assessed by using Intubation Difficulty score (Table
      1), Thyromental distance and Upper lip bite test.

      Adverse effects of A number unsuccessful attempts of intubation, complications encountered
      during intubation (bleeding, lacerations, dental injury, etc.,), and optimal laryngeal
      external manipulation (OLEM) during intubation will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: Computer generated randomization using envelopes
measure: Changes in blood pressure (in millimeters of Hg)
time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
description: Hemodynamic response
measure: Changes in heart rate (beats per minute)
time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
description: Hemodynamic response
measure: Arrhythmias
time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
description: Presence of arrhythmias would be noted
measure: Perioperative myocardial ischemia
time frame: Baseline before induction, 1 minutes after intubation, 5 minutes after intubation, 10 minutes after intubation
description: Presence of myocardial ischemia would be noted by ST segment changes
arm group label: Conventional MAC Laryngoscope
arm group type: Experimental
description: Patients in this group will undergo intubation using conventional macintosh laryngoscope
arm group label: C-MAC Video laryngoscope
arm group type: Experimental
description: Patients in this group will undergo intubation using video C-Mac laryngoscope
intervention type: Device
intervention name: Endotracheal intubation using a laryngoscope
description: Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded
arm group label: C-MAC Video laryngoscope
arm group label: Conventional MAC Laryngoscope
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sehrish Khan, MBBS
phone: 923347126366
email: sehrish.khan@aku.edu
last name: Khalid Samad, MBBS,FCPS(Anesthesiology)
phone: 923343311603
email: khalid.samad@aku.edu
facility: 
status: Recruiting
contact: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Sehrish khan
investigator title: Resident