<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/NCT03240042</url>
  </required_header>
  <id_info>
    <org_study_id>2017-07-013C</org_study_id>
    <nct_id>NCT03240042</nct_id>
  </id_info>
  <brief_title>Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery</brief_title>
  <official_title>Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Veterans General Hospital, Taiwan</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>
      When the retractor blades oped and is positioned to provide the surgical access in the&#xD;
      anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure&#xD;
      on the tissue between the retractor and the trachea. This is convincible as revealed by the&#xD;
      increase of cuff pressure of endotracheal tube. The study aims to investigate differences in&#xD;
      the increase of cuff pressure after retractor is positioned between nasotracheal and&#xD;
      orotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When the retractor blades oped and is positioned to provide the surgical access in the&#xD;
      anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure&#xD;
      on the tissue between the retractor and the trachea. The most important structure is the&#xD;
      recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure&#xD;
      of endotracheal tube. The pressure created by the retractor may be related to postoperative&#xD;
      dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some&#xD;
      neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is&#xD;
      on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or&#xD;
      orotracheal tube can both be applied to general anesthesia for the anterior cervical spine&#xD;
      surgery. The option depends on the surgeons' preference. Though both approaches end at the&#xD;
      trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth&#xD;
      angle, on the opposite side of surgical approach. The investigators hypothetize this&#xD;
      difference in location results in different degree of deviation and increase of cuff&#xD;
      pressure. The study aims to investigate differences in the increase of cuff pressure after&#xD;
      retractor is positioned between nasoendotracheal and oroendotracheal intubation.&#xD;
&#xD;
      Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as&#xD;
      being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry&#xD;
      of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are&#xD;
      set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a&#xD;
      extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal&#xD;
      intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more&#xD;
      centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure&#xD;
      from this tube may be relatively evenly distributed, and the pressure on the surrounding&#xD;
      tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a&#xD;
      nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or&#xD;
      post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in&#xD;
      the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint)&#xD;
      and post-ACSS dysphonia (secondary endpoint).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">June 16, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</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 are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cuff pressure</measure>
    <time_frame>from time of randomization until postoperative 30 days</time_frame>
    <description>cuff pressure of endotracheal tube</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sore throat</measure>
    <time_frame>from time of randomization until postoperative 30 days</time_frame>
    <description>postoperative sore throat by numerical rating scale (NRS), ranging from 0-10cm, 0 denoting minimal sore throat, 10 denoting maximal sore throat. score of 0 represents better outcome than score of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dysphonia</measure>
    <time_frame>from time of randomization until postoperative 30 days</time_frame>
    <description>postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dysphagia</measure>
    <time_frame>rom time of randomization until postoperative 30 days</time_frame>
    <description>postoperative dysphonia by BAZAZ dysphagia scoring system. Severity of dsyphagia is classified as none, mild, moderate and severe. None indicates no swallowing difficulty for liquid and solid food. Mild indicated no difficulty for liquid, and rare diffilulty for solid food. Moderate indicates none or rare difficulty for liquid, occasional difficulty for solid. Severe indicates presence of difficulty for liquid and frequent difficulty for solid food.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Pressure Injury</condition>
  <condition>Dysphonia</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Nasoendo group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oroendo group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>nasotracheal intubation</intervention_name>
    <description>The participants either receive intubation via nasal route.</description>
    <arm_group_label>Nasoendo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>orotracheal intubation</intervention_name>
    <description>The participants either receive intubation via oral route.</description>
    <arm_group_label>Oroendo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Aged 20-80 Scheduled cervical spine surgery, anterior approach&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe spinal stenosis and requiring fiberoptic intubation&#xD;
&#xD;
          -  Unstable spine and require orthosis&#xD;
&#xD;
          -  Hisotory of difficult intubation&#xD;
&#xD;
          -  History of cervical spine or neck surgery&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Nasal pathology&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  History of previous cervical spine or neck surgery&#xD;
&#xD;
          -  Anterior cervical spine surgeries after trauma, tumour resection, or spinal infection&#xD;
&#xD;
          -  Preoperative dysphonia or dysphagia, regardless of the aetiology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen-Cheng Huang, M.D.,Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosurgery, Neurological Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Veterans General Hospital, Taiwan</investigator_affiliation>
    <investigator_full_name>vghtpe user</investigator_full_name>
    <investigator_title>Principal Investigator, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>anterior cervical spine surgery</keyword>
  <keyword>endotracheal cuff pressure</keyword>
  <keyword>endotracheal tracheal intubation</keyword>
  <keyword>dysphonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysphonia</mesh_term>
    <mesh_term>Hoarseness</mesh_term>
    <mesh_term>Crush Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03240042
org study id: 2017-07-013C
nct id: NCT03240042
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
When the retractor blades oped and is positioned to provide the surgical access in the
      anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure
      on the tissue between the retractor and the trachea. This is convincible as revealed by the
      increase of cuff pressure of endotracheal tube. The study aims to investigate differences in
      the increase of cuff pressure after retractor is positioned between nasotracheal and
      orotracheal intubation.
When the retractor blades oped and is positioned to provide the surgical access in the
      anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure
      on the tissue between the retractor and the trachea. The most important structure is the
      recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure
      of endotracheal tube. The pressure created by the retractor may be related to postoperative
      dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some
      neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is
      on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or
      orotracheal tube can both be applied to general anesthesia for the anterior cervical spine
      surgery. The option depends on the surgeons' preference. Though both approaches end at the
      trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth
      angle, on the opposite side of surgical approach. The investigators hypothetize this
      difference in location results in different degree of deviation and increase of cuff
      pressure. The study aims to investigate differences in the increase of cuff pressure after
      retractor is positioned between nasoendotracheal and oroendotracheal intubation.

      Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as
      being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry
      of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are
      set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a
      extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal
      intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more
      centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure
      from this tube may be relatively evenly distributed, and the pressure on the surrounding
      tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a
      nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or
      post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in
      the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint)
      and post-ACSS dysphonia (secondary endpoint).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: cuff pressure
time frame: from time of randomization until postoperative 30 days
description: cuff pressure of endotracheal tube
measure: sore throat
time frame: from time of randomization until postoperative 30 days
description: postoperative sore throat by numerical rating scale (NRS), ranging from 0-10cm, 0 denoting minimal sore throat, 10 denoting maximal sore throat. score of 0 represents better outcome than score of 10.
measure: dysphonia
time frame: from time of randomization until postoperative 30 days
description: postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.
measure: dysphagia
time frame: rom time of randomization until postoperative 30 days
description: postoperative dysphonia by BAZAZ dysphagia scoring system. Severity of dsyphagia is classified as none, mild, moderate and severe. None indicates no swallowing difficulty for liquid and solid food. Mild indicated no difficulty for liquid, and rare diffilulty for solid food. Moderate indicates none or rare difficulty for liquid, occasional difficulty for solid. Severe indicates presence of difficulty for liquid and frequent difficulty for solid food.
arm group label: Nasoendo group
arm group type: Experimental
description: Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.
arm group label: Oroendo group
arm group type: Other
description: Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.
intervention type: Procedure
intervention name: nasotracheal intubation
description: The participants either receive intubation via nasal route.
arm group label: Nasoendo group
intervention type: Procedure
intervention name: orotracheal intubation
description: The participants either receive intubation via oral route.
arm group label: Oroendo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Wen-Cheng Huang, M.D.,Ph.D.
role: Principal Investigator
affiliation: Department of Neurosurgery, Neurological Institute
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Veterans General Hospital, Taiwan
investigator full name: vghtpe user
investigator title: Principal Investigator, Associate Professor
mesh term: Dysphonia
mesh term: Hoarseness
mesh term: Crush Injuries
sharing ipd: Undecided