<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/NCT02263300</url>
  </required_header>
  <id_info>
    <org_study_id>STU00098465</org_study_id>
    <nct_id>NCT02263300</nct_id>
  </id_info>
  <brief_title>Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial</brief_title>
  <official_title>Does Spatial Orientation Affect the Rate of Learning Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on&#xD;
      the development of fiberoptic intubation skills?&#xD;
&#xD;
      Is it necessary to teach both orientations or is the supine view transferable to the upright&#xD;
      position?&#xD;
&#xD;
      Which method demonstrates longer skill retention?&#xD;
&#xD;
      The hypotheses: Both orientations must be practiced and the upright skill is harder to learn&#xD;
      but is retained for longer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following IRB approval, written consent to participate in the study will be obtained from&#xD;
      medical students&#xD;
&#xD;
      Phase one :&#xD;
&#xD;
      Forty medical students, novices in fiberoptic intubation use will be recruited and randomly&#xD;
      assigned into one of two groups:&#xD;
&#xD;
      Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented&#xD;
      in the supine position. Learning curves, global rating scale and checklist will then be&#xD;
      obtained by a blinded examiner with the medical student using a real fiberoptic on a&#xD;
      mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same&#xD;
      medical student will then perform the intubation with the mannequin in both positions.&#xD;
&#xD;
      Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented&#xD;
      in the upright position. Learning curves, global assessment score and checklist will then be&#xD;
      obtained by a blinded examiner with the medical student using a real fiberoptic on a&#xD;
      mannequin oriented in the UPRIGHT then SUPINEposition.At the end of one week, the same&#xD;
      medical student will then perform the intubation with the mannequin in both positions.&#xD;
&#xD;
      Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented&#xD;
      in the supine position. Learning curves, global assessment score and checklist will then be&#xD;
      obtained by a blinded examiner with the medical student using a real fiberoptic on a&#xD;
      mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same&#xD;
      medical student will then perform the intubation with the mannequin in both positions.&#xD;
&#xD;
      Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx&#xD;
      oriented in the upright position. Learning curves, global assessment score and checklist will&#xD;
      then be obtained by a blinded examiner with the medical student using a real fiberoptic on a&#xD;
      mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same&#xD;
      medical student will then perform the intubation with the mannequin in both positions.&#xD;
&#xD;
      teaching testing testing week testing testing&#xD;
&#xD;
      Group A supine supine upright random random random random B upright upright supine random&#xD;
      random random random C supine upright supine random random random random D upright supine&#xD;
      upright random random&#xD;
&#xD;
      Phase two:&#xD;
&#xD;
      Study candidates will randomly be assigned(20 per group) to practice for 15minutes/day their&#xD;
      intubations skills with the iLarynx application downloaded to their smart phones or iPads.&#xD;
      The other group (20candidates) will be asked not to practice their intubation skills. At the&#xD;
      end of one week both groups will be retested on a mannequin by the same blinded examiner to&#xD;
      obtain a new learning curve, global assessment score and checklist. Both orientations of the&#xD;
      mannequin will be tested and the order randomly assigned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 30, 2015</completion_date>
  <primary_completion_date type="Actual">March 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Elapsed time to mannequin intubation with fiberoptic scope.</measure>
    <time_frame>2 minutes</time_frame>
    <description>The elapsed time of intubation with fiberoptic scope of a mannequin. Stop watch is started at passing teeth and ends when scope reaches carina.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global rating scale (GRS)</measure>
    <time_frame>2 minutes</time_frame>
    <description>Global rating scale (GRS) and assessment of medical students skill demonstrated during fiberoptic intubation of a mannequin on a score of 1-5 1 being very poor and 5 being clearly superior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examiner check list (ECL) scores</measure>
    <time_frame>2 mintues</time_frame>
    <description>The ECL will be used to measure the students proficiency with the fiberoptic scope on a scale of 0-5 for each attempt.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Airway Management</condition>
  <arm_group>
    <arm_group_label>Supine- Supine</arm_group_label>
    <description>Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upright-upright</arm_group_label>
    <description>Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supine -upright</arm_group_label>
    <description>Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Upright - supine</arm_group_label>
    <description>Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Third and fourth year medical students.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Third and fourth year medical student&#xD;
&#xD;
          -  no previous training in fiberoptic intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond Glassenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Badurdeen S, Abdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii video-gaming ability predicts laparoscopic skill. Surg Endosc. 2010 Aug;24(8):1824-8. doi: 10.1007/s00464-009-0862-z. Epub 2010 Jan 28.</citation>
    <PMID>20108147</PMID>
  </reference>
  <reference>
    <citation>Boet S, Bould MD, Schaeffer R, Fischhof S, Stojeba N, Naik VN, Diemunsch P. Learning fibreoptic intubation with a virtual computer program transfers to 'hands on' improvement. Eur J Anaesthesiol. 2010 Jan;27(1):31-5. doi: 10.1097/EJA.0b013e3283312725.</citation>
    <PMID>19851113</PMID>
  </reference>
  <reference>
    <citation>De Oliveira GS Jr, Glassenberg R, Chang R, Fitzgerald P, McCarthy RJ. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013 Oct;68(10):1053-8. doi: 10.1111/anae.12379. Epub 2013 Aug 19.</citation>
    <PMID>23952805</PMID>
  </reference>
  <reference>
    <citation>Goldmann K, Steinfeldt T. Acquisition of basic fiberoptic intubation skills with a virtual reality airway simulator. J Clin Anesth. 2006 May;18(3):173-8. doi: 10.1016/j.jclinane.2005.08.021.</citation>
    <PMID>16731318</PMID>
  </reference>
  <reference>
    <citation>Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.</citation>
    <PMID>19034097</PMID>
  </reference>
  <reference>
    <citation>Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic skills: developing an endoscopic dexterity training system for anesthesiologists. J Clin Anesth. 2002 Dec;14(8):615-9. doi: 10.1016/s0952-8180(02)00456-7.</citation>
    <PMID>12565124</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Raymond Glassenberg</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fiberoptic Intubation</keyword>
  <keyword>Medical student</keyword>
  <keyword>Virtual larynx</keyword>
  <keyword>Didactic Training</keyword>
  <keyword>Medical Education</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02263300/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02263300
org study id: STU00098465
nct id: NCT02263300
lead sponsor: 
has dmc: No
Does spatial orientation of a novice in relation to a mannequin (supine vs upright) impact on
      the development of fiberoptic intubation skills?

      Is it necessary to teach both orientations or is the supine view transferable to the upright
      position?

      Which method demonstrates longer skill retention?

      The hypotheses: Both orientations must be practiced and the upright skill is harder to learn
      but is retained for longer.
Following IRB approval, written consent to participate in the study will be obtained from
      medical students

      Phase one :

      Forty medical students, novices in fiberoptic intubation use will be recruited and randomly
      assigned into one of two groups:

      Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented
      in the supine position. Learning curves, global rating scale and checklist will then be
      obtained by a blinded examiner with the medical student using a real fiberoptic on a
      mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same
      medical student will then perform the intubation with the mannequin in both positions.

      Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented
      in the upright position. Learning curves, global assessment score and checklist will then be
      obtained by a blinded examiner with the medical student using a real fiberoptic on a
      mannequin oriented in the UPRIGHT then SUPINEposition.At the end of one week, the same
      medical student will then perform the intubation with the mannequin in both positions.

      Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented
      in the supine position. Learning curves, global assessment score and checklist will then be
      obtained by a blinded examiner with the medical student using a real fiberoptic on a
      mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same
      medical student will then perform the intubation with the mannequin in both positions.

      Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx
      oriented in the upright position. Learning curves, global assessment score and checklist will
      then be obtained by a blinded examiner with the medical student using a real fiberoptic on a
      mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same
      medical student will then perform the intubation with the mannequin in both positions.

      teaching testing testing week testing testing

      Group A supine supine upright random random random random B upright upright supine random
      random random random C supine upright supine random random random random D upright supine
      upright random random

      Phase two:

      Study candidates will randomly be assigned(20 per group) to practice for 15minutes/day their
      intubations skills with the iLarynx application downloaded to their smart phones or iPads.
      The other group (20candidates) will be asked not to practice their intubation skills. At the
      end of one week both groups will be retested on a mannequin by the same blinded examiner to
      obtain a new learning curve, global assessment score and checklist. Both orientations of the
      mannequin will be tested and the order randomly assigned.
observational model: Case-Crossover
time perspective: Prospective
measure: Elapsed time to mannequin intubation with fiberoptic scope.
time frame: 2 minutes
description: The elapsed time of intubation with fiberoptic scope of a mannequin. Stop watch is started at passing teeth and ends when scope reaches carina.
measure: Global rating scale (GRS)
time frame: 2 minutes
description: Global rating scale (GRS) and assessment of medical students skill demonstrated during fiberoptic intubation of a mannequin on a score of 1-5 1 being very poor and 5 being clearly superior.
measure: Examiner check list (ECL) scores
time frame: 2 mintues
description: The ECL will be used to measure the students proficiency with the fiberoptic scope on a scale of 0-5 for each attempt.
arm group label: Supine- Supine
description: Group A (supine-supine) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global rating scale and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week,the same medical student will then perform the intubation with the mannequin in both positions.
arm group label: Upright-upright
description: Group B (upright-upright) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position.At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
arm group label: Supine -upright
description: Group C( supine -upright) will first practice fiberoptic intubation with the iLarynx oriented in the supine position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the UPRIGHT then SUPINE position. At the end of one week, The same medical student will then perform the intubation with the mannequin in both positions.
arm group label: Upright - supine
description: Group D( upright - supine) will first practice fiberoptic intubation with the iLarynx oriented in the upright position. Learning curves, global assessment score and checklist will then be obtained by a blinded examiner with the medical student using a real fiberoptic on a mannequin oriented in the SUPINE then UPRIGHT position. At the end of one week, the same medical student will then perform the intubation with the mannequin in both positions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raymond Glassenberg, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
citation: Badurdeen S, Abdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii video-gaming ability predicts laparoscopic skill. Surg Endosc. 2010 Aug;24(8):1824-8. doi: 10.1007/s00464-009-0862-z. Epub 2010 Jan 28.
PMID: 20108147
citation: Boet S, Bould MD, Schaeffer R, Fischhof S, Stojeba N, Naik VN, Diemunsch P. Learning fibreoptic intubation with a virtual computer program transfers to 'hands on' improvement. Eur J Anaesthesiol. 2010 Jan;27(1):31-5. doi: 10.1097/EJA.0b013e3283312725.
PMID: 19851113
citation: De Oliveira GS Jr, Glassenberg R, Chang R, Fitzgerald P, McCarthy RJ. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013 Oct;68(10):1053-8. doi: 10.1111/anae.12379. Epub 2013 Aug 19.
PMID: 23952805
citation: Goldmann K, Steinfeldt T. Acquisition of basic fiberoptic intubation skills with a virtual reality airway simulator. J Clin Anesth. 2006 May;18(3):173-8. doi: 10.1016/j.jclinane.2005.08.021.
PMID: 16731318
citation: Chandra DB, Savoldelli GL, Joo HS, Weiss ID, Naik VN. Fiberoptic oral intubation: the effect of model fidelity on training for transfer to patient care. Anesthesiology. 2008 Dec;109(6):1007-13. doi: 10.1097/ALN.0b013e31818d6c3c.
PMID: 19034097
citation: Marsland CP, Robinson BJ, Chitty CH, Guy BJ. Acquisition and maintenance of endoscopic skills: developing an endoscopic dexterity training system for anesthesiologists. J Clin Anesth. 2002 Dec;14(8):615-9. doi: 10.1016/s0952-8180(02)00456-7.
PMID: 12565124
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Raymond Glassenberg
investigator title: Principal Investigator
sharing ipd: No
provided document: 