<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/NCT03810937</url>
  </required_header>
  <id_info>
    <org_study_id>ANS004</org_study_id>
    <nct_id>NCT03810937</nct_id>
  </id_info>
  <brief_title>Optimal Head and Neck Position for Videolaryngoscopy</brief_title>
  <official_title>Optimal Head and Neck Position for Videolaryngoscopy Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Fahad Specialist Hospital Dammam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Fahad Specialist Hospital Dammam</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The introduction of videolaryngoscopy constituted a revolution in airway management since it&#xD;
      could provide better laryngeal exposure (indirect) in situations of difficult or impossible&#xD;
      visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always&#xD;
      guarantee adequate exposure or end up always in successful tracheal intubation. Failed&#xD;
      tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the&#xD;
      failure was due to omitting some preparatory steps, including optimal head positioning,&#xD;
      leading to a less than expected exposure and/or difficult or impossible intubation. There are&#xD;
      no recommendations currently from the scientific organizations regarding the optimal head&#xD;
      position when using a GlideScope and it is unknown currently whether head position can affect&#xD;
      visualization or tracheal intubation attempts when using this device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Multicentric,randomized, prospective and controlled study.&#xD;
&#xD;
        -  After Institutional Review Board approval, signed written informed consents will be&#xD;
           obtained from 165 adult patients with American Society of Anesthesiologists physical&#xD;
           status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.&#xD;
&#xD;
        -  The following parameters will assessed and documented during the preoperative airway&#xD;
           evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and&#xD;
           modified Mallampati classification. An 8cm non-compressible pillow.&#xD;
&#xD;
        -  Patients will be randomized following coin toss into two groups depending on intubation&#xD;
           position; Group Sniffing position(S) for obverse side and group flat position(F) for&#xD;
           reverse side&#xD;
&#xD;
        -  After premedication, American Society of Anesthesiologists' standard monitors will be&#xD;
           applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia&#xD;
           induction and complete muscle relaxation as evidenced by loss of all evoked adductor&#xD;
           pollicis responses to train of four stimulation of the ulnar nerve:&#xD;
&#xD;
        -  Group sniffing (S): investigator will start by performing first videolaryngoscopy to&#xD;
           find best view in flat position then the anesthesiologist will remove the Glidescope and&#xD;
           the patient will be positioned in sniffing position using the pillow and another&#xD;
           videolaryngoscopy will be attempted in sniffing position to find best view in this&#xD;
           position and the patient will be intubated in this position.&#xD;
&#xD;
        -  Group flat (F): same procedure will be done but starting from sniffing position and the&#xD;
           patient will be intubated in flat position.&#xD;
&#xD;
        -  The laryngoscopist will be asked not to use external laryngeal manipulation and to use&#xD;
           the same lifting force throughout the study period. If these maneuvers deemed necessary&#xD;
           for tracheal intubation (no visualization of vocal cords from full inflation to full&#xD;
           deflation or the reverse, the laryngoscopist will be asked grade the view before&#xD;
           applying the maneuver then use the required maneuver and record which intervention was&#xD;
           needed and utilized.&#xD;
&#xD;
        -  The estimated time to review theses different head elevation degrees is around 45&#xD;
           seconds.&#xD;
&#xD;
        -  After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without&#xD;
           significant desaturation. Investigator will exclude also patients with high risk of&#xD;
           desaturation (obesity and initial low saturation).&#xD;
&#xD;
        -  The indirect laryngoscopic views will be graded using the same grading method used for&#xD;
           direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis&#xD;
           opening viewed) will be also used to subcategorize subjects whose views lie between&#xD;
           grade 1 and 3 C&amp;L.&#xD;
&#xD;
      Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded&#xD;
      researcher who was not involved with airway management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 1, 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>
    <intervention_model_description>Participants will be randomized in 2 groups:&#xD;
Group sniffing (S): we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.&#xD;
Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>optimal head position during videolaryngoscopy intubation</measure>
    <time_frame>intratracheal intubation procedure</time_frame>
    <description>the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>best laryngeal exposure</measure>
    <time_frame>intratracheal intubation procedure</time_frame>
    <description>the best laryngeal exposure (according to modified Cormack and Lehane classification) head position</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Airway Complication of Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group sniffing (S)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Flat (F)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>head position</intervention_name>
    <description>head positioning in sniffing or flat position</description>
    <arm_group_label>Group Flat (F)</arm_group_label>
    <arm_group_label>Group sniffing (S)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with American Society of Anesthesiologists physical status 1-3 who are&#xD;
             scheduled for elective surgery requiring endotracheal intubation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of difficult intubation, poor dentition, gastroesophageal reflux disease&#xD;
             ,initial low oxygen saturation, severe/morbid obesity (body mass index [BMI] greater&#xD;
             than 35 kg/m2),neck deformities, atlano-axial subluxation or at risk of aspiration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MUNIR H BAMADHAJ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Fahad Specialist Hospital Dammam</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MUNIR H BAMADHAJ, MD</last_name>
    <phone>00966138442222</phone>
    <phone_ext>3993</phone_ext>
    <email>MUNIR.BAMDHAJ@KFSH.MED.SA</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ZAKI M ALZAHER, MD</last_name>
    <phone>00966138442222</phone>
    <phone_ext>3939</phone_ext>
    <email>ZAKI.ALZAHIR@KFSH.MED.SA</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>King Fahad Specialist Hospital</name>
      <address>
        <city>Dammam</city>
        <state>Eastern Province</state>
        <zip>31444</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>AHED M ZAIDANE, MD</last_name>
      <phone>+966138442222</phone>
      <phone_ext>3993</phone_ext>
      <email>AHED.ZEIDAN@KFSH.MED.SA</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Fahad Specialist Hospital Dammam</investigator_affiliation>
    <investigator_full_name>Munir Bamadhaj</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03810937
org study id: ANS004
nct id: NCT03810937
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The introduction of videolaryngoscopy constituted a revolution in airway management since it
      could provide better laryngeal exposure (indirect) in situations of difficult or impossible
      visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always
      guarantee adequate exposure or end up always in successful tracheal intubation. Failed
      tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the
      failure was due to omitting some preparatory steps, including optimal head positioning,
      leading to a less than expected exposure and/or difficult or impossible intubation. There are
      no recommendations currently from the scientific organizations regarding the optimal head
      position when using a GlideScope and it is unknown currently whether head position can affect
      visualization or tracheal intubation attempts when using this device.
-  Multicentric,randomized, prospective and controlled study.

        -  After Institutional Review Board approval, signed written informed consents will be
           obtained from 165 adult patients with American Society of Anesthesiologists physical
           status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.

        -  The following parameters will assessed and documented during the preoperative airway
           evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and
           modified Mallampati classification. An 8cm non-compressible pillow.

        -  Patients will be randomized following coin toss into two groups depending on intubation
           position; Group Sniffing position(S) for obverse side and group flat position(F) for
           reverse side

        -  After premedication, American Society of Anesthesiologists' standard monitors will be
           applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia
           induction and complete muscle relaxation as evidenced by loss of all evoked adductor
           pollicis responses to train of four stimulation of the ulnar nerve:

        -  Group sniffing (S): investigator will start by performing first videolaryngoscopy to
           find best view in flat position then the anesthesiologist will remove the Glidescope and
           the patient will be positioned in sniffing position using the pillow and another
           videolaryngoscopy will be attempted in sniffing position to find best view in this
           position and the patient will be intubated in this position.

        -  Group flat (F): same procedure will be done but starting from sniffing position and the
           patient will be intubated in flat position.

        -  The laryngoscopist will be asked not to use external laryngeal manipulation and to use
           the same lifting force throughout the study period. If these maneuvers deemed necessary
           for tracheal intubation (no visualization of vocal cords from full inflation to full
           deflation or the reverse, the laryngoscopist will be asked grade the view before
           applying the maneuver then use the required maneuver and record which intervention was
           needed and utilized.

        -  The estimated time to review theses different head elevation degrees is around 45
           seconds.

        -  After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without
           significant desaturation. Investigator will exclude also patients with high risk of
           desaturation (obesity and initial low saturation).

        -  The indirect laryngoscopic views will be graded using the same grading method used for
           direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis
           opening viewed) will be also used to subcategorize subjects whose views lie between
           grade 1 and 3 C&L.

      Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded
      researcher who was not involved with airway management.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized in 2 groups:
Group sniffing (S): we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.
measure: optimal head position during videolaryngoscopy intubation
time frame: intratracheal intubation procedure
description: the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.
measure: best laryngeal exposure
time frame: intratracheal intubation procedure
description: the best laryngeal exposure (according to modified Cormack and Lehane classification) head position
arm group label: Group sniffing (S)
arm group type: Active Comparator
description: intervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
arm group label: Group Flat (F)
arm group type: Active Comparator
description: intervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
intervention type: Other
intervention name: head position
description: head positioning in sniffing or flat position
arm group label: Group Flat (F)
arm group label: Group sniffing (S)
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: MUNIR H BAMADHAJ, MD
role: Principal Investigator
affiliation: King Fahad Specialist Hospital Dammam
last name: MUNIR H BAMADHAJ, MD
phone: 00966138442222
phone ext: 3993
email: MUNIR.BAMDHAJ@KFSH.MED.SA
last name: ZAKI M ALZAHER, MD
phone: 00966138442222
phone ext: 3939
email: ZAKI.ALZAHIR@KFSH.MED.SA
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Fahad Specialist Hospital Dammam
investigator full name: Munir Bamadhaj
investigator title: Principal Investigator
sharing ipd: No