<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/NCT03003455</url>
  </required_header>
  <id_info>
    <org_study_id>201112757</org_study_id>
    <nct_id>NCT03003455</nct_id>
  </id_info>
  <brief_title>Nasotracheal Intubation Over a Bougie</brief_title>
  <official_title>Nasotracheal Intubation Over a Bougie Placed Via a Subsequently Removed Nasal Trumpet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether nasal intubation over a bougie placed via a&#xD;
      nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind&#xD;
      nasal endotracheal tube passage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional nasotracheal intubation techniques (or &quot;Conventional Videolaryngoscopic&#xD;
      Techniques,&quot; CVT) are known to be associated with significant trauma to the patient's nares&#xD;
      and the endotracheal tube itself. The investigators propose an alternative technique&#xD;
      (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or&#xD;
      NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which&#xD;
      promises to not only be less traumatic to the patient and the endotracheal tube, but also to&#xD;
      take less time to perform and have a higher first-attempt success rate than conventional&#xD;
      methods. The investigators propose a randomized prospective interventional study comparing&#xD;
      this new technique with conventional technique to see if a significant difference exists.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nasal trauma</measure>
    <time_frame>60-90 seconds post-intubation</time_frame>
    <description>Bleeding noted on nasopharyngeal exam by surgical resident</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nasal trauma</measure>
    <time_frame>5 minutes post-intubation</time_frame>
    <description>Bleeding noted on nasopharyngeal exam by surgical resident</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to intubation</measure>
    <time_frame>Measured immediately post-intubation</time_frame>
    <description>Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First attempt success rate</measure>
    <time_frame>Measured immediately post-intubation</time_frame>
    <description>Whether or not there was successful nasotracheal intubation on the first attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Magill forceps</measure>
    <time_frame>Measured Immediately post-intubation</time_frame>
    <description>Whether or not Magill forceps were used during airway management</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">257</enrollment>
  <condition>Nasotracheal Intubation</condition>
  <condition>Nasal Bleeding</condition>
  <arm_group>
    <arm_group_label>Conventional Nasotracheal Intubation (CVT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasotracheal Intubation Over a Bougie (NIB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nasotracheal intubation over a bougie</intervention_name>
    <description>Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps</description>
    <arm_group_label>Nasotracheal Intubation Over a Bougie (NIB)</arm_group_label>
    <other_name>Abrons technique for nasotracheal intubation</other_name>
    <other_name>Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet</other_name>
    <other_name>NIB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Nasotracheal Intubation</intervention_name>
    <description>Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps</description>
    <arm_group_label>Conventional Nasotracheal Intubation (CVT)</arm_group_label>
    <other_name>CVT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective surgery with an anesthetic plan including asleep&#xD;
             nasotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients needing emergent airway protection&#xD;
&#xD;
          -  Patients undergoing emergency surgery&#xD;
&#xD;
          -  Patients whom are known to be pregnant&#xD;
&#xD;
          -  Patients whom are currently anticoagulated (including daily aspirin use)&#xD;
&#xD;
          -  Patients whose anesthetic includes the use of nitrous oxide&#xD;
&#xD;
          -  Patients whom are currently incarcerated&#xD;
&#xD;
          -  Patients 7 years of age or younger&#xD;
&#xD;
          -  Mentally incompetent adults&#xD;
&#xD;
          -  Patients whom refuse involvement in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Elwood T, Stillions DM, Woo DW, Bradford HM, Ramamoorthy C. Nasotracheal intubation: a randomized trial of two methods. Anesthesiology. 2002 Jan;96(1):51-3. doi: 10.1097/00000542-200201000-00014.</citation>
    <PMID>11753001</PMID>
  </reference>
  <reference>
    <citation>O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.</citation>
    <PMID>8686823</PMID>
  </reference>
  <reference>
    <citation>Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.</citation>
    <PMID>16527796</PMID>
  </reference>
  <reference>
    <citation>Abrons RO, Vansickle RA, Ouanes JP. Seldinger technique for nasal intubation: a case series. J Clin Anesth. 2016 Nov;34:609-11. doi: 10.1016/j.jclinane.2016.06.027. Epub 2016 Jul 19.</citation>
    <PMID>27687457</PMID>
  </reference>
  <reference>
    <citation>Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.</citation>
    <PMID>9059115</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Abrons, Ron O</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Nasotracheal Intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epistaxis</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/NCT03003455
org study id: 201112757
nct id: NCT03003455
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether nasal intubation over a bougie placed via a
      nasal trumpet will decrease nasal trauma when compared to the conventional technique of blind
      nasal endotracheal tube passage.
Conventional nasotracheal intubation techniques (or "Conventional Videolaryngoscopic
      Techniques," CVT) are known to be associated with significant trauma to the patient's nares
      and the endotracheal tube itself. The investigators propose an alternative technique
      (Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet, or
      NIB) which involves using Seldinger technique over a bougie placed via a nasal trumpet which
      promises to not only be less traumatic to the patient and the endotracheal tube, but also to
      take less time to perform and have a higher first-attempt success rate than conventional
      methods. The investigators propose a randomized prospective interventional study comparing
      this new technique with conventional technique to see if a significant difference exists.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Nasal trauma
time frame: 60-90 seconds post-intubation
description: Bleeding noted on nasopharyngeal exam by surgical resident
measure: Nasal trauma
time frame: 5 minutes post-intubation
description: Bleeding noted on nasopharyngeal exam by surgical resident
measure: Time to intubation
time frame: Measured immediately post-intubation
description: Time from first entrance of ETT or bougie into the nare to the presence of end-tidal CO2 via nasotracheal ETT
measure: First attempt success rate
time frame: Measured immediately post-intubation
description: Whether or not there was successful nasotracheal intubation on the first attempt
measure: Need for Magill forceps
time frame: Measured Immediately post-intubation
description: Whether or not Magill forceps were used during airway management
arm group label: Conventional Nasotracheal Intubation (CVT)
arm group type: Active Comparator
description: Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
arm group label: Nasotracheal Intubation Over a Bougie (NIB)
arm group type: Experimental
description: Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
intervention type: Procedure
intervention name: Nasotracheal intubation over a bougie
description: Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
arm group label: Nasotracheal Intubation Over a Bougie (NIB)
other name: Abrons technique for nasotracheal intubation
other name: Nasotracheal intubation over a bougie placed via a subsequently removed nasal trumpet
other name: NIB
intervention type: Procedure
intervention name: Conventional Nasotracheal Intubation
description: Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
arm group label: Conventional Nasotracheal Intubation (CVT)
other name: CVT
criteria: 
gender: All
minimum age: 8 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Elwood T, Stillions DM, Woo DW, Bradford HM, Ramamoorthy C. Nasotracheal intubation: a randomized trial of two methods. Anesthesiology. 2002 Jan;96(1):51-3. doi: 10.1097/00000542-200201000-00014.
PMID: 11753001
citation: O'Connell JE, Stevenson DS, Stokes MA. Pathological changes associated with short-term nasal intubation. Anaesthesia. 1996 Apr;51(4):347-50. doi: 10.1111/j.1365-2044.1996.tb07746.x.
PMID: 8686823
citation: Morimoto Y, Sugimura M, Hirose Y, Taki K, Niwa H. Nasotracheal intubation under curve-tipped suction catheter guidance reduces epistaxis. Can J Anaesth. 2006 Mar;53(3):295-8. doi: 10.1007/BF03022218.
PMID: 16527796
citation: Abrons RO, Vansickle RA, Ouanes JP. Seldinger technique for nasal intubation: a case series. J Clin Anesth. 2016 Nov;34:609-11. doi: 10.1016/j.jclinane.2016.06.027. Epub 2016 Jul 19.
PMID: 27687457
citation: Cossham PS. Nasotracheal tube placement over a bougie. Anaesthesia. 1997 Feb;52(2):184-5. No abstract available.
PMID: 9059115
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Abrons, Ron O
investigator title: Assistant Professor of Anesthesiology
mesh term: Epistaxis
sharing ipd: No