<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/NCT03279172</url>
  </required_header>
  <id_info>
    <org_study_id>22051012</org_study_id>
    <nct_id>NCT03279172</nct_id>
  </id_info>
  <brief_title>A Comparison of Videolaryngoscope and Direct Laryngoscope in IOP Changes, Throat Pain, IT and Hemodynamic Variables</brief_title>
  <acronym>IOP</acronym>
  <official_title>A Comparison of Videolaryngoscope and Direct Laryngoscope in Intraocular Pressure Changes, Throat Pain, Intubation Time and Hemodynamic Variables</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</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 aim of the study was to compare intraocular pressure, intubation time, throat pain and&#xD;
      hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring&#xD;
      endotracheal intubation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the&#xD;
      difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013&#xD;
      (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases&#xD;
      of difficult airway, glottic visualisation is obtained more easily and less airway trauma is&#xD;
      seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3,&#xD;
      and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a&#xD;
      camera which is connected to a video screen monitor. In addition to passing soft tissues by&#xD;
      visualisation, the camera is helpful in defining the glottic appearance (1).&#xD;
&#xD;
      There are studies which have compared the hemodynamic response and increase in IOP in&#xD;
      intubation using direct laryngoscope and various videolaryngoscopes and airway devices .&#xD;
      However, to the best of our knowledge there is no study comparing the effect on the increase&#xD;
      in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to&#xD;
      compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the&#xD;
      direct laryngoscope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">August 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 3, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>High intraorbital pressure</measure>
    <time_frame>1 minute</time_frame>
    <description>IOP 18-22 mmHg</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Intraocular Pressure</condition>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>Group Direct Laryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>direct laryngoscope (macintosh laryngoscope) is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Macintosh laryingoscope, BIS monitoring and tonometry would be used in Group Direct Laryngoscope.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group videolaryngoscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Videolaryngoscope is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Video laryingoscope, BIS monitoring and tonometry would be used in Group Video Laryngoscope.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>direct laryngoscope</intervention_name>
    <description>procedure entubatıon</description>
    <arm_group_label>Group Direct Laryngoscope</arm_group_label>
    <arm_group_label>Group videolaryngoscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>videolaryngoscope</intervention_name>
    <arm_group_label>Group Direct Laryngoscope</arm_group_label>
    <arm_group_label>Group videolaryngoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective Surgery under general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of Glaucoma&#xD;
&#xD;
          -  History of hearth disease&#xD;
&#xD;
          -  History of Alzheimer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ceyda Ozhan Caparlar</last_name>
    <role>Study Director</role>
    <affiliation>University of Health Dıskapı Yıldırım Beyazıt Training and Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Dıskapı Yıldırım Beyazıt Training and Hospital</name>
      <address>
        <city>Ankara</city>
        <state>Altındag</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.</citation>
    <PMID>22042705</PMID>
  </reference>
  <results_reference>
    <citation>Vinayagam S, Dhanger S, Tilak P, Gnanasekar R. C-MAC(R) video laryngoscope with D-BLADE and Frova introducer for awake intubation in a patient with parapharyngeal mass. Saudi J Anaesth. 2016 Oct-Dec;10(4):471-473. doi: 10.4103/1658-354X.179118.</citation>
    <PMID>27833500</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ceyda Ozhan Caparlar</investigator_full_name>
    <investigator_title>Principle investigator, Clinical Specialist of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>videolaryngoscope</keyword>
  <keyword>intraocular pressure</keyword>
  <keyword>Direct laryngoscope</keyword>
  <pending_results>
    <submitted>November 12, 2017</submitted>
    <returned>August 16, 2018</returned>
  </pending_results>
  <!-- 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/NCT03279172
org study id: 22051012
nct id: NCT03279172
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to compare intraocular pressure, intubation time, throat pain and
      hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring
      endotracheal intubation
INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the
      difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013
      (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases
      of difficult airway, glottic visualisation is obtained more easily and less airway trauma is
      seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3,
      and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a
      camera which is connected to a video screen monitor. In addition to passing soft tissues by
      visualisation, the camera is helpful in defining the glottic appearance (1).

      There are studies which have compared the hemodynamic response and increase in IOP in
      intubation using direct laryngoscope and various videolaryngoscopes and airway devices .
      However, to the best of our knowledge there is no study comparing the effect on the increase
      in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to
      compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the
      direct laryngoscope.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: High intraorbital pressure
time frame: 1 minute
description: IOP 18-22 mmHg
arm group label: Group Direct Laryngoscope
arm group type: Experimental
description: direct laryngoscope (macintosh laryngoscope) is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Macintosh laryingoscope, BIS monitoring and tonometry would be used in Group Direct Laryngoscope.
arm group label: Group videolaryngoscope
arm group type: Experimental
description: Videolaryngoscope is used in elective surgeries with maximal duration time for two hours. Standard anaesthesia was used on group and BIS monitorisation was applied. A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation. Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia. The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor. Video laryingoscope, BIS monitoring and tonometry would be used in Group Video Laryngoscope.
intervention type: Procedure
intervention name: direct laryngoscope
description: procedure entubatıon
arm group label: Group Direct Laryngoscope
arm group label: Group videolaryngoscope
intervention type: Procedure
intervention name: videolaryngoscope
arm group label: Group Direct Laryngoscope
arm group label: Group videolaryngoscope
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ceyda Ozhan Caparlar
role: Study Director
affiliation: University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
facility: 
country: Turkey
citation: Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.
PMID: 22042705
citation: Vinayagam S, Dhanger S, Tilak P, Gnanasekar R. C-MAC(R) video laryngoscope with D-BLADE and Frova introducer for awake intubation in a patient with parapharyngeal mass. Saudi J Anaesth. 2016 Oct-Dec;10(4):471-473. doi: 10.4103/1658-354X.179118.
PMID: 27833500
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: Ceyda Ozhan Caparlar
investigator title: Principle investigator, Clinical Specialist of anesthesiology
submitted: November 12, 2017
returned: August 16, 2018