<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/NCT02191904</url>
  </required_header>
  <id_info>
    <org_study_id>alkin01</org_study_id>
    <nct_id>NCT02191904</nct_id>
  </id_info>
  <brief_title>Laryngoscope Types and The Cervical Motion</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trakya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Trakya University</source>
  <brief_summary>
    <textblock>
      To ensure minimal cervical motion during the intubation of trauma patients is important for&#xD;
      the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.&#xD;
&#xD;
      Intubation is required to secure the airway in patient during an anesthesia management or a&#xD;
      mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for&#xD;
      intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,&#xD;
      various types of laryngoscopes have been developed to be used for in case of difficult&#xD;
      intubations, the intubation of the patients with head and neck trauma, or the intubation&#xD;
      attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly&#xD;
      developed laryngoscopes, integrated with an optical view system.&#xD;
&#xD;
      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently&#xD;
      introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type&#xD;
      laryngoscopes, having an angle of 46° at the end of blade and including a camera system that&#xD;
      magnifies the image.&#xD;
&#xD;
      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed&#xD;
      type of laryngoscope, including optical imaging system. There is a channel on the device for&#xD;
      the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before&#xD;
      the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which&#xD;
      provides glottis display without any deviation in the normal position of the oral, pharyngeal&#xD;
      or the tracheal axes.&#xD;
&#xD;
      In the literature, there are many studies comparing the effects of these newly developed&#xD;
      laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.&#xD;
      However, in these studies, individual vertebral motion was reported during the placement of&#xD;
      the tube, while the angulation of the head and neck and the difficulty of the intubations&#xD;
      were not clear.&#xD;
&#xD;
      In this study our first hypothesis was cervical motion during endotracheal intubation in&#xD;
      Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one&#xD;
      was the endotracheal intubation time is similar to the Macintosh that is used more often.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CERVICAL MOTIONS</measure>
    <time_frame>January 2011 and December 2012</time_frame>
    <description>While the ventilation with face mask, different manupulations could be performed to the head. Therefore, neutral position was applied to the head before the laryngsocpy. In this procedure, the head was stabilized as the infraorbital edge and tragus is perpendicular to the ground. An inclinometer (A 360 degree angle gauge) was placed on the forehead of the patients, so that the tip of the inclinometer fits to glabellar line (figure 2,3). Inner diameter of the intubation tubes used for females and males were 7 to 7.5 mm and 8 to 8.5 mm, respectively. The maximum angulation were measured by an inclinometer and recorded from beginning of the laryngoscopy to the placement of the intubation tube into the trachea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intubation Time</measure>
    <time_frame>January 2011 and December 2012</time_frame>
    <description>The duration between the beginning of the laryngoscope blade from passing the lips and the placement of the tube into trachea was recorded as intubation process time.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Cervical Motion During Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Truview EVO2®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Airtraq®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes</intervention_name>
    <arm_group_label>Airtraq®</arm_group_label>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_label>Truview EVO2®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patients who will undergo general anesthesia for abdominal surgery, American Society of&#xD;
        Anesthesiologists physical status I to III, The patients who were aged between 20 and 75&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Our exclusion criteria were to have a history of emergency intubation or a difficult&#xD;
        intubation, to have a body mass index higher than 35 or a rheumatologic disease that cause&#xD;
        limitation of cervical motion, to have a previous history of cervical operation or tumor,&#xD;
        trauma or infection on upper airway, and to have no tooth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Trakya University</investigator_affiliation>
    <investigator_full_name>Alkin Colak</investigator_full_name>
    <investigator_title>Associate professor</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/NCT02191904
org study id: alkin01
nct id: NCT02191904
lead sponsor: 
To ensure minimal cervical motion during the intubation of trauma patients is important for
      the prevention of cervical spine injury (CSI) or further deterioration of existing CSI.

      Intubation is required to secure the airway in patient during an anesthesia management or a
      mechanical ventilation at intensive care units. Laryngoscopes are the assisting tools for
      intubations. The most widely used laryngoscope type is one with a Macintosh blade. However,
      various types of laryngoscopes have been developed to be used for in case of difficult
      intubations, the intubation of the patients with head and neck trauma, or the intubation
      attempts carried out by inexperienced individuals. Truview EVO2® and Airtraq® are newly
      developed laryngoscopes, integrated with an optical view system.

      The Truphatek TruView EVO2® (Truphatek International Ltd, Netanya, Israel) is a recently
      introduced, easy viewing type of laryngoscope, modified from the blades of Macintosh type
      laryngoscopes, having an angle of 46° at the end of blade and including a camera system that
      magnifies the image.

      The Airtraq® laryngoscope (ATQ; King Medical Systems, Newark, DE) is also a newly developed
      type of laryngoscope, including optical imaging system. There is a channel on the device for
      the placement of the endotracheal tube. Endotracheal tube is inserted into the channel before
      the laryngoscopy. It has been reported that Airtraq is a novel single use laryngoscope which
      provides glottis display without any deviation in the normal position of the oral, pharyngeal
      or the tracheal axes.

      In the literature, there are many studies comparing the effects of these newly developed
      laryngoscopes on cervical motions in different scenarios with cadavers and normal patients.
      However, in these studies, individual vertebral motion was reported during the placement of
      the tube, while the angulation of the head and neck and the difficulty of the intubations
      were not clear.

      In this study our first hypothesis was cervical motion during endotracheal intubation in
      Truview EVO2® and Airtraq® types of laryngoscopes is lesser than Macintosh. The second one
      was the endotracheal intubation time is similar to the Macintosh that is used more often.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: CERVICAL MOTIONS
time frame: January 2011 and December 2012
description: While the ventilation with face mask, different manupulations could be performed to the head. Therefore, neutral position was applied to the head before the laryngsocpy. In this procedure, the head was stabilized as the infraorbital edge and tragus is perpendicular to the ground. An inclinometer (A 360 degree angle gauge) was placed on the forehead of the patients, so that the tip of the inclinometer fits to glabellar line (figure 2,3). Inner diameter of the intubation tubes used for females and males were 7 to 7.5 mm and 8 to 8.5 mm, respectively. The maximum angulation were measured by an inclinometer and recorded from beginning of the laryngoscopy to the placement of the intubation tube into the trachea.
measure: Intubation Time
time frame: January 2011 and December 2012
description: The duration between the beginning of the laryngoscope blade from passing the lips and the placement of the tube into trachea was recorded as intubation process time.
arm group label: Truview EVO2®
arm group type: Active Comparator
description: Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively.
arm group label: Airtraq®
arm group type: Active Comparator
description: Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively
arm group label: Direct laryngoscopy
arm group type: Active Comparator
description: Patients were randomly assigned into three groups with the sealed envelope method according to the laryngoscope type, which we had and we were used to; Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes were used in direct laryngoscopy Group DL (n=50), Truview EVO2® Group TV (n=50) and Airtraq® Group ATQ (n=50), respectively
intervention type: Other
intervention name: Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes
arm group label: Airtraq®
arm group label: Direct laryngoscopy
arm group label: Truview EVO2®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Trakya University
investigator full name: Alkin Colak
investigator title: Associate professor