<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/NCT03808896</url>
  </required_header>
  <id_info>
    <org_study_id>TCHCCT-ZXERRP</org_study_id>
    <nct_id>NCT03808896</nct_id>
  </id_info>
  <brief_title>TCHCCT-Zhong-Xing-Emergency-Department-airway-clincal (TTC)</brief_title>
  <official_title>Taipei City Hospital ZhongXing Branch, Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei City Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei City 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>
      In the previous study on mannekin, the investigators found stylet-assisted lifting of&#xD;
      epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb)&#xD;
      without increasing subjective difficulty. It has no expenses other than the routine&#xD;
      intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy&#xD;
      can improve first pass intubation rate in the emergency department. However, bougie is a&#xD;
      disposable device and may increased medical expenditure. The investigators will evaluate the&#xD;
      safety of bougie and epiglottic lifting technique, as well as the first pass and overall&#xD;
      success rate of intubation comparing to traditional video laryngoscopy and direct&#xD;
      laryngoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous&#xD;
      study. The investigators' research results had been accepted and published by the journal&#xD;
      BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical&#xD;
      trial to investigate the impact of this technique clinically. Besides, bougie assisted&#xD;
      intubation is a effective, evidenced-proved intervention. The investigators will also like to&#xD;
      find out the prognosis differences between these two techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">February 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2021</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>Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>first pass success rate</measure>
    <time_frame>through the intubation period, an average of 90 seconds</time_frame>
    <description>first pass sucess rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of intubation</measure>
    <time_frame>through the intubation period, an average of 90 seconds</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate complications direct related to intubation process</measure>
    <time_frame>through the intubation period, an average of 90 seconds</time_frame>
    <description>esophageal intubation, bleeding, tracheal perforation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall success rate</measure>
    <time_frame>within 48 hours of intubation</time_frame>
    <description>Include all intubation event</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Intubation;Difficult</condition>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>bougie-assisted intubation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intubation with epiglottic lifting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional intubation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stylet-assisted epiglottic lifting</intervention_name>
    <description>use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube</description>
    <arm_group_label>intubation with epiglottic lifting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bougie-assisted intubation</intervention_name>
    <description>use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.</description>
    <arm_group_label>bougie-assisted intubation</arm_group_label>
    <other_name>bougie introducer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all the patients present to the emergency department with airway emergency who need&#xD;
             intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age below 18 year-old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taipei City Hospital Zhong-Xing branch</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tzu-Yao Hung, MD</last_name>
      <phone>886-2-979305599</phone>
      <email>bryansolitude@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Driver B, Dodd K, Klein LR, Buckley R, Robinson A, McGill JW, Reardon RF, Prekker ME. The Bougie and First-Pass Success in the Emergency Department. Ann Emerg Med. 2017 Oct;70(4):473-478.e1. doi: 10.1016/j.annemergmed.2017.04.033.</citation>
    <PMID>28601269</PMID>
  </reference>
  <reference>
    <citation>Ueda W, Arai YP. The Use of a Stylet to Aid the Lifting of the Epiglottis With a Video Laryngoscope. Anesth Pain Med. 2016 May 24;6(4):e38507. doi: 10.5812/aapm.38507. eCollection 2016 Aug.</citation>
    <PMID>27843782</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei City Hospital</investigator_affiliation>
    <investigator_full_name>Hung,Tzu-Yao</investigator_full_name>
    <investigator_title>Director of emergency department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <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/NCT03808896
org study id: TCHCCT-ZXERRP
nct id: NCT03808896
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the previous study on mannekin, the investigators found stylet-assisted lifting of
      epiglottis is an useful technique on difficult airway (Cormack-Lehane grade IIIa, IIIb)
      without increasing subjective difficulty. It has no expenses other than the routine
      intubation process. Recently, the studies have proved that the bougie-assisted laryngoscopy
      can improve first pass intubation rate in the emergency department. However, bougie is a
      disposable device and may increased medical expenditure. The investigators will evaluate the
      safety of bougie and epiglottic lifting technique, as well as the first pass and overall
      success rate of intubation comparing to traditional video laryngoscopy and direct
      laryngoscopy.
A better strategy of managing Cormack-Lehane Grade III had been investigated by our previous
      study. The investigators' research results had been accepted and published by the journal
      BioMeidcal Central Anesthesiology. The investigators will be eager to do the further clinical
      trial to investigate the impact of this technique clinically. Besides, bougie assisted
      intubation is a effective, evidenced-proved intervention. The investigators will also like to
      find out the prognosis differences between these two techniques.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Traditional intubation technique direct and video laryngoscope, bougie-assisted intubation, intubation with stylet assisted epiglottis lifting
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: first pass success rate
time frame: through the intubation period, an average of 90 seconds
description: first pass sucess rate
measure: duration of intubation
time frame: through the intubation period, an average of 90 seconds
measure: Immediate complications direct related to intubation process
time frame: through the intubation period, an average of 90 seconds
description: esophageal intubation, bleeding, tracheal perforation
measure: Overall success rate
time frame: within 48 hours of intubation
description: Include all intubation event
arm group label: bougie-assisted intubation
arm group type: Active Comparator
description: use bougie as guide, intubation with loading endotracheal tube under direct or video laryngoscopy
arm group label: intubation with epiglottic lifting
arm group type: Active Comparator
description: Lifting of epiglottis with stylet-equipped endotracheal tube to assist intubation under direct or video laryngoscopy
arm group label: Traditional intubation
arm group type: No Intervention
description: intubation under direct or video laryngoscopy without epiglottis lifting nor bougie-assited
intervention type: Procedure
intervention name: stylet-assisted epiglottic lifting
description: use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
arm group label: intubation with epiglottic lifting
intervention type: Device
intervention name: bougie-assisted intubation
description: use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.
arm group label: bougie-assisted intubation
other name: bougie introducer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Driver B, Dodd K, Klein LR, Buckley R, Robinson A, McGill JW, Reardon RF, Prekker ME. The Bougie and First-Pass Success in the Emergency Department. Ann Emerg Med. 2017 Oct;70(4):473-478.e1. doi: 10.1016/j.annemergmed.2017.04.033.
PMID: 28601269
citation: Ueda W, Arai YP. The Use of a Stylet to Aid the Lifting of the Epiglottis With a Video Laryngoscope. Anesth Pain Med. 2016 May 24;6(4):e38507. doi: 10.5812/aapm.38507. eCollection 2016 Aug.
PMID: 27843782
responsible party type: Principal Investigator
investigator affiliation: Taipei City Hospital
investigator full name: Hung,Tzu-Yao
investigator title: Director of emergency department
mesh term: Emergencies
sharing ipd: No