<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/NCT03759561</url>
  </required_header>
  <id_info>
    <org_study_id>VL_FOB</org_study_id>
    <nct_id>NCT03759561</nct_id>
  </id_info>
  <brief_title>Tracheal Intubation Using Videolaryngoscope vs Fiberoptic Bronchoscope in Patients With Cervical Immobilization</brief_title>
  <official_title>A Prospective Randomized Trial on Comparison of Tracheal Intubation Using Videolaryngoscope Versus Fiberoptic Bronchoscope in Patients Undergoing Cervical Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with suspected cervical spine injury, cervical immobilization, such as manual&#xD;
      in-line stabilization or cervical collar has been adopted to prevent further neurologic&#xD;
      injury due to cervical motion. In these patients, tracheal intubation with direct&#xD;
      laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head&#xD;
      extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used&#xD;
      for tracheal intubation in such patients. In this study, the initial success rate of tracheal&#xD;
      intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will&#xD;
      be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients entered the operating room without premedication. Airway-related parameters&#xD;
      (modified Mallampati score, interincisior gap, thyromental distance, sternomental distance,&#xD;
      and retrognathia) were evaluated in the sitting position. After changing to the supine&#xD;
      position, thyromental height was measured and patients were monitored with&#xD;
      electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and processed&#xD;
      electroencephalography. Cotton towels were placed below the patient's head for horizontal&#xD;
      alignment of the external auditory meatus and the suprasternal notch. After sufficient&#xD;
      preoxygenation for &gt; 3 min, total intravenous anaesthesia was induced using a&#xD;
      target-controlled infusion of propofol and remifentanil (effect site concentration: 4 µg/mL&#xD;
      for propofol and 4 ng/mL for remifentanil). After confirming loss of consciousness,&#xD;
      rocuronium (0.6-0.8 mg/kg) was administered to facilitate tracheal intubation, and mask&#xD;
      ventilation was conducted. During mask ventilation, its difficulty was assessed and the use&#xD;
      of the oropharyngeal airway was recorded. For invasive blood pressure measurement, a 20-gauge&#xD;
      catheter was placed on the patient's radial artery. Thereafter, the patient's head was placed&#xD;
      in the neutral position and an cervical collar was applied to minimise neck movement during&#xD;
      intubation.&#xD;
&#xD;
      About 90 s after administrating rocuronium, tracheal intubation was attempted by one of five&#xD;
      attending anaesthesiologists with a collective history of more than 30 successful&#xD;
      videolaryngoscopic and fiberscopic intubations. A reinforced tracheal tube was used in both&#xD;
      groups. Orotracheal intubation was performed using a videolaryngoscope with a disposable&#xD;
      Macintosh-typed blade and a malleable stylet in the videolaryngoscope group, and using a&#xD;
      flexible fiberscope with an eyepiece in the fiberscope group. A tracheal tube was mounted on&#xD;
      the stylet and flexible fiberscope in the videolaryngoscope and fiberscope groups,&#xD;
      respectively. The stylet was angulated about 60° at the proximal margin of the cuff. Tracheal&#xD;
      intubation was initially attempted without any assistance, including airway manoeuvres and&#xD;
      devices. If additional airway manoeuvres including external laryngeal manipulation (ELM), jaw&#xD;
      thrust, and tongue traction were required during intubation attempts, they were performed by&#xD;
      an assistant and noted. After confirming the glottis, the percentage of glottic opening&#xD;
      (POGO) score was recorded just before inserting the tracheal tube into the trachea. The&#xD;
      tracheal tube was inserted into the trachea after removing the stylet and confirming the&#xD;
      carina in the videolaryngoscope and fiberscope groups, respectively. Successful intubation&#xD;
      was confirmed by waveform capnography. The time from oral insertion of the intubation device&#xD;
      to obtainment of the glottis view (glottis visualisation time), to placement of the tracheal&#xD;
      tube (tube placement time), and to detection of the waveform capnograph (capnograph detection&#xD;
      time) were also measured.&#xD;
&#xD;
      A maximum of three intubation attempts were allowed for the same anaesthesiologist, with a&#xD;
      180-s time limit for each attempt. If the peripheral oxygen saturation (SpO2) decreased to&#xD;
      below 90% during the intubation attempt, the attempt was considered to have failed, and&#xD;
      rescue mask ventilation was conducted until SpO2 reached 100%. Cases where tracheal&#xD;
      intubation was unsuccessful on all three attempts were recorded as intubation failure.&#xD;
&#xD;
      After surgery, intubation-related airway complications were investigated. Airway injuries&#xD;
      (blood in the oral cavity, blood staining on the tracheal tube, gum bleeding, and dental&#xD;
      trauma) were assessed at the end of surgery. In addition, hoarseness and sore throat were&#xD;
      evaluated at 1 h and 24 h after surgery. The severity of sore throat was measured using a&#xD;
      numeric rating scale (NRS; 0: no pain, 10: worst pain imaginable).&#xD;
&#xD;
      Mean blood pressure (MBP), heart rate (HR), SpO2, and bispectral index (BIS) were recorded&#xD;
      just before the intubation attempt and at 1 min after successful intubation. Other&#xD;
      perioperative data (demographic, anaesthetic, and surgical data) were collected from&#xD;
      electronic medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">January 18, 2022</completion_date>
  <primary_completion_date type="Actual">January 17, 2022</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The initial success rate</measure>
    <time_frame>intraoperatively</time_frame>
    <description>The first-pass success was defined as successful tracheal intubation on a single attempt in all stages of tracheal intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intubation time</measure>
    <time_frame>intraoperatively</time_frame>
    <description>Intubation time was defined as time interval between insertion of the device into the oral cavity and withdrawal of the device from the oral cavity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the incidence of complication</measure>
    <time_frame>intraoperatively to 1hour and 24 hours after the surgery</time_frame>
    <description>The complications after the procedure included blood in the oral cavity, blood staining on the endotracheal tube, sore throat, and hoarseness. Blood in the oral cavity and blood staining on the endotracheal tube will be evaluated intraoperatively. Sore throat and hoarseness will be evaluated at 1 hour and 24 hours after the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">340</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <arm_group>
    <arm_group_label>Videolaryngoscope group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the videolaryngoscope group, tracheal intubation was performed using videolaryngoscope under cervical collar application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fiberoptic bronchoscope group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the fiberoptic bronchoscope group, tracheal intubation was performed using fiberoptic bronchoscope via oral cavity under cervical collar application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intubation with videolaryngoscope vs fiberoptic bronchoscope</intervention_name>
    <description>Tracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations</description>
    <arm_group_label>Fiberoptic bronchoscope group</arm_group_label>
    <arm_group_label>Videolaryngoscope group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who require tracheal intubation&#xD;
&#xD;
          -  Adult patients aged 20-80&#xD;
&#xD;
          -  American Society of anesthesiologists physical status classification Ⅰ-Ⅲ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's refusal&#xD;
&#xD;
          -  patients had a high risk of aspiration, history of gastroesophageal reflux disease,&#xD;
             coagulopathy, previous history of radiation therapy on the neck and airway surgery,&#xD;
             and upper airway lesions (i.e., tumor, polyp, inflammation, trauma, abscess, and&#xD;
             foreign body)&#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>Hee-pyoung Park, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03759561
org study id: VL_FOB
nct id: NCT03759561
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In patients with suspected cervical spine injury, cervical immobilization, such as manual
      in-line stabilization or cervical collar has been adopted to prevent further neurologic
      injury due to cervical motion. In these patients, tracheal intubation with direct
      laryngoscopy is often challenging due to limited mouth opening, neck flexion, and head
      extension. In this situation, videolaryngoscope and fiberoptic bronchoscope have been used
      for tracheal intubation in such patients. In this study, the initial success rate of tracheal
      intubation and intubation time between the videolaryngoscope and fiberoptic bronchoscope will
      be compared.
Patients entered the operating room without premedication. Airway-related parameters
      (modified Mallampati score, interincisior gap, thyromental distance, sternomental distance,
      and retrognathia) were evaluated in the sitting position. After changing to the supine
      position, thyromental height was measured and patients were monitored with
      electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and processed
      electroencephalography. Cotton towels were placed below the patient's head for horizontal
      alignment of the external auditory meatus and the suprasternal notch. After sufficient
      preoxygenation for > 3 min, total intravenous anaesthesia was induced using a
      target-controlled infusion of propofol and remifentanil (effect site concentration: 4 µg/mL
      for propofol and 4 ng/mL for remifentanil). After confirming loss of consciousness,
      rocuronium (0.6-0.8 mg/kg) was administered to facilitate tracheal intubation, and mask
      ventilation was conducted. During mask ventilation, its difficulty was assessed and the use
      of the oropharyngeal airway was recorded. For invasive blood pressure measurement, a 20-gauge
      catheter was placed on the patient's radial artery. Thereafter, the patient's head was placed
      in the neutral position and an cervical collar was applied to minimise neck movement during
      intubation.

      About 90 s after administrating rocuronium, tracheal intubation was attempted by one of five
      attending anaesthesiologists with a collective history of more than 30 successful
      videolaryngoscopic and fiberscopic intubations. A reinforced tracheal tube was used in both
      groups. Orotracheal intubation was performed using a videolaryngoscope with a disposable
      Macintosh-typed blade and a malleable stylet in the videolaryngoscope group, and using a
      flexible fiberscope with an eyepiece in the fiberscope group. A tracheal tube was mounted on
      the stylet and flexible fiberscope in the videolaryngoscope and fiberscope groups,
      respectively. The stylet was angulated about 60° at the proximal margin of the cuff. Tracheal
      intubation was initially attempted without any assistance, including airway manoeuvres and
      devices. If additional airway manoeuvres including external laryngeal manipulation (ELM), jaw
      thrust, and tongue traction were required during intubation attempts, they were performed by
      an assistant and noted. After confirming the glottis, the percentage of glottic opening
      (POGO) score was recorded just before inserting the tracheal tube into the trachea. The
      tracheal tube was inserted into the trachea after removing the stylet and confirming the
      carina in the videolaryngoscope and fiberscope groups, respectively. Successful intubation
      was confirmed by waveform capnography. The time from oral insertion of the intubation device
      to obtainment of the glottis view (glottis visualisation time), to placement of the tracheal
      tube (tube placement time), and to detection of the waveform capnograph (capnograph detection
      time) were also measured.

      A maximum of three intubation attempts were allowed for the same anaesthesiologist, with a
      180-s time limit for each attempt. If the peripheral oxygen saturation (SpO2) decreased to
      below 90% during the intubation attempt, the attempt was considered to have failed, and
      rescue mask ventilation was conducted until SpO2 reached 100%. Cases where tracheal
      intubation was unsuccessful on all three attempts were recorded as intubation failure.

      After surgery, intubation-related airway complications were investigated. Airway injuries
      (blood in the oral cavity, blood staining on the tracheal tube, gum bleeding, and dental
      trauma) were assessed at the end of surgery. In addition, hoarseness and sore throat were
      evaluated at 1 h and 24 h after surgery. The severity of sore throat was measured using a
      numeric rating scale (NRS; 0: no pain, 10: worst pain imaginable).

      Mean blood pressure (MBP), heart rate (HR), SpO2, and bispectral index (BIS) were recorded
      just before the intubation attempt and at 1 min after successful intubation. Other
      perioperative data (demographic, anaesthetic, and surgical data) were collected from
      electronic medical records.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The initial success rate
time frame: intraoperatively
description: The first-pass success was defined as successful tracheal intubation on a single attempt in all stages of tracheal intubation
measure: intubation time
time frame: intraoperatively
description: Intubation time was defined as time interval between insertion of the device into the oral cavity and withdrawal of the device from the oral cavity.
measure: the incidence of complication
time frame: intraoperatively to 1hour and 24 hours after the surgery
description: The complications after the procedure included blood in the oral cavity, blood staining on the endotracheal tube, sore throat, and hoarseness. Blood in the oral cavity and blood staining on the endotracheal tube will be evaluated intraoperatively. Sore throat and hoarseness will be evaluated at 1 hour and 24 hours after the surgery
arm group label: Videolaryngoscope group
arm group type: Active Comparator
description: In the videolaryngoscope group, tracheal intubation was performed using videolaryngoscope under cervical collar application.
arm group label: Fiberoptic bronchoscope group
arm group type: Active Comparator
description: In the fiberoptic bronchoscope group, tracheal intubation was performed using fiberoptic bronchoscope via oral cavity under cervical collar application.
intervention type: Procedure
intervention name: intubation with videolaryngoscope vs fiberoptic bronchoscope
description: Tracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations
arm group label: Fiberoptic bronchoscope group
arm group label: Videolaryngoscope group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hee-pyoung Park, MD,PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No