<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/NCT04482166</url>
  </required_header>
  <id_info>
    <org_study_id>2006-160-1135</org_study_id>
    <nct_id>NCT04482166</nct_id>
  </id_info>
  <brief_title>Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device</brief_title>
  <official_title>Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal&#xD;
      intubation through supraglottic airway device for pediatric difficult airway manikin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residents under anesthesiology training will undergo a simulation practice to a pediatric&#xD;
      airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal&#xD;
      intubation through supraglottic airway device. The participants will do the same practice 20&#xD;
      times to the same manikin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Elapsed time to succeed endotracheal intubation for each training period</measure>
    <time_frame>From start of each training period to success of endotracheal intubation, not to exceed 10 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period</measure>
    <time_frame>From start of each training period to success of ventilation, not to exceed 10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period</measure>
    <time_frame>From start of each training period to identification of vocal cords, not to exceed 10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period</measure>
    <time_frame>From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of endotracheal intubation for each training period</measure>
    <time_frame>From start of each training period to success of endotracheal intubation, not to exceed 10 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of trials</measure>
    <time_frame>From start of each training period to success of endotracheal intubation, not to exceed 10 minutes</time_frame>
    <description>Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>Candidates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin</description>
    <arm_group_label>Candidates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>supraglottic airway device</intervention_name>
    <description>supraglottic airway device</description>
    <arm_group_label>Candidates</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents under anesthesiology training with experience of more than 30 times of&#xD;
             supraglottic airway device insertion and manipulation of fiberoptic bronchoscope&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway&#xD;
             device&#xD;
&#xD;
          -  Prior experience of training for fiberoptic-guided tracheal intubation through&#xD;
             supraglottic airway device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji-Hyun Lee, M.D., Ph.D.</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>
        <state>Other</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5.</citation>
    <PMID>32022437</PMID>
  </reference>
  <reference>
    <citation>Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16.</citation>
    <PMID>31887239</PMID>
  </reference>
  <reference>
    <citation>Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.</citation>
    <PMID>25684039</PMID>
  </reference>
  <reference>
    <citation>Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.</citation>
    <PMID>26956516</PMID>
  </reference>
  <reference>
    <citation>Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.</citation>
    <PMID>21710368</PMID>
  </reference>
  <reference>
    <citation>Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368.</citation>
    <PMID>30908421</PMID>
  </reference>
  <reference>
    <citation>Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7.</citation>
    <PMID>28577552</PMID>
  </reference>
  <reference>
    <citation>Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20.</citation>
    <PMID>31583796</PMID>
  </reference>
  <reference>
    <citation>Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8):1235. doi: 10.3390/jcm8081235.</citation>
    <PMID>31426378</PMID>
  </reference>
  <reference>
    <citation>Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29.</citation>
    <PMID>33329810</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Ji-Hyun Lee</investigator_full_name>
    <investigator_title>Clinical associate professor</investigator_title>
  </responsible_party>
  <keyword>Fiberoptic bronchoscope</keyword>
  <keyword>Supraglottic airway</keyword>
  <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/NCT04482166
org study id: 2006-160-1135
nct id: NCT04482166
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal
      intubation through supraglottic airway device for pediatric difficult airway manikin.
Residents under anesthesiology training will undergo a simulation practice to a pediatric
      airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal
      intubation through supraglottic airway device. The participants will do the same practice 20
      times to the same manikin.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Elapsed time to succeed endotracheal intubation for each training period
time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
measure: Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period
time frame: From start of each training period to success of ventilation, not to exceed 10 minutes
measure: Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period
time frame: From start of each training period to identification of vocal cords, not to exceed 10 minutes
measure: Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period
time frame: From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes
measure: Success rate of endotracheal intubation for each training period
time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
measure: Number of trials
time frame: From start of each training period to success of endotracheal intubation, not to exceed 10 minutes
description: Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period
arm group label: Candidates
arm group type: Experimental
description: Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
intervention type: Other
intervention name: Training
description: 20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
arm group label: Candidates
intervention type: Device
intervention name: supraglottic airway device
description: supraglottic airway device
arm group label: Candidates
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ji-Hyun Lee, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5.
PMID: 32022437
citation: Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16.
PMID: 31887239
citation: Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.
PMID: 25684039
citation: Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.
PMID: 26956516
citation: Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.
PMID: 21710368
citation: Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368.
PMID: 30908421
citation: Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7.
PMID: 28577552
citation: Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20.
PMID: 31583796
citation: Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8):1235. doi: 10.3390/jcm8081235.
PMID: 31426378
citation: Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29.
PMID: 33329810
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Ji-Hyun Lee
investigator title: Clinical associate professor
sharing ipd: No