<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/NCT02245880</url>
  </required_header>
  <id_info>
    <org_study_id>KOÜ KAEK 2013/33</org_study_id>
    <nct_id>NCT02245880</nct_id>
  </id_info>
  <brief_title>Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach</brief_title>
  <official_title>A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intubation must be done with utmost care in cervical trauma patients. cervical spine motion&#xD;
      must be minimized and intubation must be fast. The aim of this study was to compare the&#xD;
      effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients&#xD;
      undergoing elective surgery were enrolled in this trial. After standard monitorisation&#xD;
      including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with&#xD;
      propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were&#xD;
      divided into two groups glidescope and fastrach. Rigid collar was placed then patients were&#xD;
      intubated with one of these devices. Mask ventilations with or without collar were recorded.&#xD;
      insertion times, intubation times of the devices were recorded. Peroperative hemodynamic&#xD;
      parameters and postoperative minor complications were also recoded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring&#xD;
      intubation exclusion criteria:&#xD;
&#xD;
      - pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intubation times</measure>
    <time_frame>From handling of the device till intıbation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>From Preoperative heart rate till 15 minutes After intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>From preinduction till 15 minutes after intubation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>minor complications</measure>
    <time_frame>From the end of surgery till 2 hours postoperatively</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mucosal damage</measure>
    <time_frame>Bloodstain on the device after removal</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Injury of Cervical Spine</condition>
  <arm_group>
    <arm_group_label>Glidescope videolaryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intubating laryngeal mask airway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glidescope</intervention_name>
    <description>videolaryngoscope</description>
    <arm_group_label>Glidescope videolaryngoscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ILMA</intervention_name>
    <description>handling of the device till the optimal ventilation achieved</description>
    <arm_group_label>Intubating laryngeal mask airway</arm_group_label>
    <other_name>FASTRACH</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  requiring intubation&#xD;
&#xD;
          -  BMI&lt;35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 or higher than 65&#xD;
&#xD;
          -  ASA III-IV&#xD;
&#xD;
          -  BMI&gt; 35&#xD;
&#xD;
          -  PREGNANT&#xD;
&#xD;
          -  head and neck tumors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zehra I ARSLAN, Specialist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology and Reanimation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University School of Medicine</name>
      <address>
        <city>Kocaeli</city>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>April 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Zehra Ipek ARSLAN</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cervical spine</keyword>
  <keyword>intubating laryngeal mask airway</keyword>
  <keyword>Glidescope videolaryngoscope</keyword>
  <keyword>collar</keyword>
  <!-- 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/NCT02245880
org study id: KOÜ KAEK 2013/33
nct id: NCT02245880
lead sponsor: 
has dmc: No
Intubation must be done with utmost care in cervical trauma patients. cervical spine motion
      must be minimized and intubation must be fast. The aim of this study was to compare the
      effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients
      undergoing elective surgery were enrolled in this trial. After standard monitorisation
      including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with
      propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were
      divided into two groups glidescope and fastrach. Rigid collar was placed then patients were
      intubated with one of these devices. Mask ventilations with or without collar were recorded.
      insertion times, intubation times of the devices were recorded. Peroperative hemodynamic
      parameters and postoperative minor complications were also recoded.
inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring
      intubation exclusion criteria:

      - pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: intubation times
time frame: From handling of the device till intıbation
measure: Heart rate
time frame: From Preoperative heart rate till 15 minutes After intubation
measure: Mean arterial pressure
time frame: From preinduction till 15 minutes after intubation
measure: minor complications
time frame: From the end of surgery till 2 hours postoperatively
measure: Mucosal damage
time frame: Bloodstain on the device after removal
arm group label: Glidescope videolaryngoscope
arm group type: Active Comparator
description: cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded.
arm group label: Intubating laryngeal mask airway
arm group type: Active Comparator
description: cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation
intervention type: Device
intervention name: Glidescope
description: videolaryngoscope
arm group label: Glidescope videolaryngoscope
intervention type: Device
intervention name: ILMA
description: handling of the device till the optimal ventilation achieved
arm group label: Intubating laryngeal mask airway
other name: FASTRACH
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zehra I ARSLAN, Specialist
role: Principal Investigator
affiliation: Anesthesiology and Reanimation
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Zehra Ipek ARSLAN
investigator title: Assistant Professor