<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/NCT03775317</url>
  </required_header>
  <id_info>
    <org_study_id>10272</org_study_id>
    <nct_id>NCT03775317</nct_id>
  </id_info>
  <brief_title>Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation</brief_title>
  <official_title>Comparison of Video-assisted Laryngoscopy and Direct Laryngoscopy for Routine Nasotracheal Intubation in Oral and Maxillofacial Surgery Patients: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</source>
  <oversight_info>
    <has_dmc>No</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>
      Nasotracheal intubation is a common method for securing an advanced airway during surgery for&#xD;
      procedures that involve manipulation of the oral cavity, the dentition, or the facial bones.&#xD;
      The placement of a nasotracheal tube is often more challenging, especially for learning&#xD;
      providers, even for patients with normal airway anatomy. Video laryngoscopy is an adjunctive&#xD;
      technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade and&#xD;
      provides an indirect view of the glottis during intubation through display on a monitor. The&#xD;
      use of video laryngoscopes has been shown to reduce time to intubation, result in perception&#xD;
      of easier intubation by the anesthesia team, and reduce the use of adjunctive maneuvers&#xD;
      during intubation. There is little evidence, however, to show these benefits for routine&#xD;
      nasotracheal intubation. The purpose of the study is to compare the ease of video-assisted&#xD;
      laryngoscopy and direct laryngoscopy in routine nasotracheal intubation for Maxillofacial&#xD;
      procedures. The investigators hypothesize that the use of video-assisted laryngoscopy for&#xD;
      routine nasotracheal intubation will result in quicker time to intubation, less adjunctive&#xD;
      maneuvers and anesthesia perception of easier intubation when compared to direct nasotrahceal&#xD;
      intubation. The investigators aim to compare the time to intubation, number of adjunctive&#xD;
      maneuvers and the perception of intubation difficulty in routine nasotracheal intubation for&#xD;
      Maxillofacial procedures for video-assisted laryngoscopy and direct laryngoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of video-assisted laryngoscopy and direct laryngoscopy for routine nasotracheal&#xD;
      intubation in oral and maxillofacial surgery patients: a randomized controlled trial.&#xD;
&#xD;
      INTRODUCTION Nasotracheal intubation is a common method for securing an advanced airway&#xD;
      during surgery for procedures that involve manipulation of the oral cavity, the dentition, or&#xD;
      the facial bones. The placement of a nasotracheal tube is often more challenging, especially&#xD;
      for learning providers, even for patients with normal airway anatomy. Video laryngoscopy is&#xD;
      an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope&#xD;
      blade and provides an indirect view of the glottis during intubation through display on a&#xD;
      monitor. The use of video laryngoscopes has been shown to reduce time to intubation, result&#xD;
      in perception of easier intubation by the anesthesia team, and reduce the use of adjunctive&#xD;
      maneuvers during intubation. There is little evidence, however, to show these benefits for&#xD;
      routine nasotracheal intubation. The purpose of the study is to compare the ease of&#xD;
      video-assisted laryngoscopy and direct laryngoscopy in routine nasotracheal intubation for&#xD;
      Maxillofacial procedures. The investigators hypothesize that the use of video-assisted&#xD;
      laryngoscopy for routine nasotracheal intubation will increase the rate of success on first&#xD;
      intubation attempt, result in quicker time to intubation, less adjunctive maneuvers and&#xD;
      anesthesia perception of easier intubation when compared to direct nasotrahceal intubation.&#xD;
      The investigators aim to compare the rate of first attempt intubation success, time to&#xD;
      intubation, number of adjunctive maneuvers and the perception of intubation difficulty in&#xD;
      routine nasotracheal intubation for Maxillofacial procedures for video-assisted laryngoscopy&#xD;
      and direct laryngoscopy.&#xD;
&#xD;
      METHODS Study Sample After obtaining institutional review board approval (IRB #10272), the&#xD;
      authors will design a randomized clinical trial. The eligible study population will include&#xD;
      all patients who presented to University Medical Center in New Orleans, LA for oral and&#xD;
      maxillofacial surgery to be performed under general anesthesia and planned for a nasotracheal&#xD;
      intubation. The inclusion criteria for the study will be as follows: planned for a general&#xD;
      anesthetic with nasotracheal intubation, ASA I and II and at least 18 years of age. Prisoners&#xD;
      and patients with anticipated difficult airways will be excluded from this study.&#xD;
&#xD;
      Study Design This will be a single center, parallel group, unblinded randomized controlled&#xD;
      trial with an allocation ratio of 1:1. Because the investigators hypothesized that&#xD;
      video-assisted laryngoscopy would increase the rate of success of intubation on the first&#xD;
      attempt and previous data shows this trend in a similar patient population (Tabrizi et al&#xD;
      2018), this trial will be designed to assess for superiority of the video-assisted&#xD;
      laryngoscopy. One of the investigators will explain the risks and benefits of participation&#xD;
      in the study in detail to each patient and patients will be enrolled in the study after&#xD;
      signing informed consent. A co-investigator, not involved with enrollment or the anesthetic,&#xD;
      will use a computerized research randomization software (www.randomizer.org) to perform block&#xD;
      randomization with randomly varying block sizes of 2, 4 and 6. Then, he will place a paper&#xD;
      with the group allocation written on it into sequentially numbered envelopes in the order&#xD;
      determined by the randomization software. The group allocation will be concealed by using&#xD;
      opaque envelopes that will be sealed after the paper with the group assignment is placed in&#xD;
      the envelope. When a patient is enrolled in the study, the next envelope in the sequence will&#xD;
      be labeled with the patient's study ID and opened by the principal investigator, who ensured&#xD;
      the anesthetic team then performed the technique for intubation assigned to the patient. The&#xD;
      direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation&#xD;
      utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx. The&#xD;
      video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing&#xD;
      a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.&#xD;
&#xD;
      Variables The primary outcome variable will be the success of first attempt intubation.&#xD;
      Success of intubation will be defined as confirmed placement of the endotracheal tube by&#xD;
      bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak. The secondary outcome&#xD;
      variables will be the amount of time required to secure the nasotracheal tube, the use of&#xD;
      Macgill forceps, the success at first attempt, the number of attempts, the number of&#xD;
      endotracheal tube exchanges after placement and the number of torn endotracheal tube cuffs.&#xD;
      Time for intubation will be recorded for each case by an independent observer using a&#xD;
      stopwatch which will start upon removal of the bag mask and will end after the&#xD;
      anesthesiologist confirmed bilateral breath sounds, an end-tidal CO2 waveform and lack of&#xD;
      cuff leak. Use of Macgill forceps will be recorded by an independent observer upon their use&#xD;
      during intubation. An attempt at intubation will be considered failed when the laryngoscope&#xD;
      is removed from the mouth prior to insertion of the endotracheal tube and bask mask&#xD;
      ventilation is restarted. Tube exchanges will likewise be recorded if they occur.&#xD;
&#xD;
      The predictor variable will be the laryngoscopy technique employed: video-assisted&#xD;
      laryngoscopy (the experimental group) or direct Macintosh or Miller laryngoscopy (the control&#xD;
      group). Other variables that will be recorded are age, gender, ASA score and procedure&#xD;
      performed.&#xD;
&#xD;
      Sample Size Calculation The sample size for the study was calculated based on a difference of&#xD;
      10% in first attempt success rate between groups. The investigators regarded this amount of&#xD;
      time as the smallest meaningful difference. Previously published reports was used to base the&#xD;
      sample size calculation, using a success rate of 82% and 60% for first attempt at video&#xD;
      laryngoscopy and direct laryngoscopy, respectively. An estimated sample size of 48 patients&#xD;
      (24 in each arm) will be needed to detect a difference of 10% in first attempt success rate&#xD;
      between the groups with an 80% power and alpha level of 0.05. [A previously published study&#xD;
      (Rabrizi et al 2018) assessed first attempt success rate in patients with bilateral&#xD;
      mandibular fractures in Glidescope video laryngoscopy versus Macintosh laryngoscopy. They&#xD;
      found a first attempt success rate of 82% using a video laryngoscopy versus 60% using direct&#xD;
      laryngoscopy.] Data Collection and Analysis To organize data collection, a Microsoft Excel&#xD;
      spreadsheet will be created and used to record information, which will be kept on a secured&#xD;
      LSU drive which only the investigators have access to. Data will be compiled and imported&#xD;
      into JMP Statistical Discovery for analysis (JMP, Version 12.1. SAS Institute Inc., Cary, NC,&#xD;
      1989-2015). The relationship of the primary outcome variable to the primary predictor will be&#xD;
      analyzed using Chi squared tests. The relationship of the secondary outcome variables to the&#xD;
      primary predictor will be analyzed using Chi squared tests and t tests, as appropriate for&#xD;
      the data type. Study variables will be examined for their relationship to the primary&#xD;
      predictor and primary outcome using t test, Chi squared test and ANOVA as appropriate for the&#xD;
      type of variable. A p-value of less than 0.05 will be considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success of first attempt intubation</measure>
    <time_frame>1 day</time_frame>
    <description>defined as confirmed placement of the endotracheal tube by bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>amount of time required to secure the nasotracheal tube</measure>
    <time_frame>1 day</time_frame>
    <description>amount of time required to secure the nasotracheal tube</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the use of Macgill forceps</measure>
    <time_frame>1 day</time_frame>
    <description>the use of Macgill forceps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>success at first attempt</measure>
    <time_frame>1 day</time_frame>
    <description>success at first attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of attempts</measure>
    <time_frame>1 day</time_frame>
    <description>number of attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of endotracheal tube exchanges after placement</measure>
    <time_frame>1 day</time_frame>
    <description>number of endotracheal tube exchanges after placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of torn endotracheal tube cuffs</measure>
    <time_frame>1 day</time_frame>
    <description>number of torn endotracheal tube cuffs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cormack-Lehane score</measure>
    <time_frame>1 day</time_frame>
    <description>Cormack-Lehane score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <arm_group>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Video Laryngoscopy</intervention_name>
    <description>The direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx.</description>
    <arm_group_label>Video Laryngoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Laryngoscopy</intervention_name>
    <description>The video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.</description>
    <arm_group_label>Direct Laryngoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  oral and maxillofacial surgery to be performed under general anesthesia&#xD;
&#xD;
          -  planned for a general anesthetic with nasotracheal intubation,&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  anticipated difficult airways&#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>University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brett J King, DDS</last_name>
      <phone>504-702-2000</phone>
      <email>bking6@lsuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Brett J King, DDS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian J Christensen, DDS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ira Padnos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Mancuso, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>Brett King</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Video laryngoscopy</keyword>
  <keyword>Nasal intubation</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/NCT03775317
org study id: 10272
nct id: NCT03775317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nasotracheal intubation is a common method for securing an advanced airway during surgery for
      procedures that involve manipulation of the oral cavity, the dentition, or the facial bones.
      The placement of a nasotracheal tube is often more challenging, especially for learning
      providers, even for patients with normal airway anatomy. Video laryngoscopy is an adjunctive
      technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade and
      provides an indirect view of the glottis during intubation through display on a monitor. The
      use of video laryngoscopes has been shown to reduce time to intubation, result in perception
      of easier intubation by the anesthesia team, and reduce the use of adjunctive maneuvers
      during intubation. There is little evidence, however, to show these benefits for routine
      nasotracheal intubation. The purpose of the study is to compare the ease of video-assisted
      laryngoscopy and direct laryngoscopy in routine nasotracheal intubation for Maxillofacial
      procedures. The investigators hypothesize that the use of video-assisted laryngoscopy for
      routine nasotracheal intubation will result in quicker time to intubation, less adjunctive
      maneuvers and anesthesia perception of easier intubation when compared to direct nasotrahceal
      intubation. The investigators aim to compare the time to intubation, number of adjunctive
      maneuvers and the perception of intubation difficulty in routine nasotracheal intubation for
      Maxillofacial procedures for video-assisted laryngoscopy and direct laryngoscopy.
Comparison of video-assisted laryngoscopy and direct laryngoscopy for routine nasotracheal
      intubation in oral and maxillofacial surgery patients: a randomized controlled trial.

      INTRODUCTION Nasotracheal intubation is a common method for securing an advanced airway
      during surgery for procedures that involve manipulation of the oral cavity, the dentition, or
      the facial bones. The placement of a nasotracheal tube is often more challenging, especially
      for learning providers, even for patients with normal airway anatomy. Video laryngoscopy is
      an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope
      blade and provides an indirect view of the glottis during intubation through display on a
      monitor. The use of video laryngoscopes has been shown to reduce time to intubation, result
      in perception of easier intubation by the anesthesia team, and reduce the use of adjunctive
      maneuvers during intubation. There is little evidence, however, to show these benefits for
      routine nasotracheal intubation. The purpose of the study is to compare the ease of
      video-assisted laryngoscopy and direct laryngoscopy in routine nasotracheal intubation for
      Maxillofacial procedures. The investigators hypothesize that the use of video-assisted
      laryngoscopy for routine nasotracheal intubation will increase the rate of success on first
      intubation attempt, result in quicker time to intubation, less adjunctive maneuvers and
      anesthesia perception of easier intubation when compared to direct nasotrahceal intubation.
      The investigators aim to compare the rate of first attempt intubation success, time to
      intubation, number of adjunctive maneuvers and the perception of intubation difficulty in
      routine nasotracheal intubation for Maxillofacial procedures for video-assisted laryngoscopy
      and direct laryngoscopy.

      METHODS Study Sample After obtaining institutional review board approval (IRB #10272), the
      authors will design a randomized clinical trial. The eligible study population will include
      all patients who presented to University Medical Center in New Orleans, LA for oral and
      maxillofacial surgery to be performed under general anesthesia and planned for a nasotracheal
      intubation. The inclusion criteria for the study will be as follows: planned for a general
      anesthetic with nasotracheal intubation, ASA I and II and at least 18 years of age. Prisoners
      and patients with anticipated difficult airways will be excluded from this study.

      Study Design This will be a single center, parallel group, unblinded randomized controlled
      trial with an allocation ratio of 1:1. Because the investigators hypothesized that
      video-assisted laryngoscopy would increase the rate of success of intubation on the first
      attempt and previous data shows this trend in a similar patient population (Tabrizi et al
      2018), this trial will be designed to assess for superiority of the video-assisted
      laryngoscopy. One of the investigators will explain the risks and benefits of participation
      in the study in detail to each patient and patients will be enrolled in the study after
      signing informed consent. A co-investigator, not involved with enrollment or the anesthetic,
      will use a computerized research randomization software (www.randomizer.org) to perform block
      randomization with randomly varying block sizes of 2, 4 and 6. Then, he will place a paper
      with the group allocation written on it into sequentially numbered envelopes in the order
      determined by the randomization software. The group allocation will be concealed by using
      opaque envelopes that will be sealed after the paper with the group assignment is placed in
      the envelope. When a patient is enrolled in the study, the next envelope in the sequence will
      be labeled with the patient's study ID and opened by the principal investigator, who ensured
      the anesthetic team then performed the technique for intubation assigned to the patient. The
      direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation
      utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx. The
      video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing
      a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.

      Variables The primary outcome variable will be the success of first attempt intubation.
      Success of intubation will be defined as confirmed placement of the endotracheal tube by
      bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak. The secondary outcome
      variables will be the amount of time required to secure the nasotracheal tube, the use of
      Macgill forceps, the success at first attempt, the number of attempts, the number of
      endotracheal tube exchanges after placement and the number of torn endotracheal tube cuffs.
      Time for intubation will be recorded for each case by an independent observer using a
      stopwatch which will start upon removal of the bag mask and will end after the
      anesthesiologist confirmed bilateral breath sounds, an end-tidal CO2 waveform and lack of
      cuff leak. Use of Macgill forceps will be recorded by an independent observer upon their use
      during intubation. An attempt at intubation will be considered failed when the laryngoscope
      is removed from the mouth prior to insertion of the endotracheal tube and bask mask
      ventilation is restarted. Tube exchanges will likewise be recorded if they occur.

      The predictor variable will be the laryngoscopy technique employed: video-assisted
      laryngoscopy (the experimental group) or direct Macintosh or Miller laryngoscopy (the control
      group). Other variables that will be recorded are age, gender, ASA score and procedure
      performed.

      Sample Size Calculation The sample size for the study was calculated based on a difference of
      10% in first attempt success rate between groups. The investigators regarded this amount of
      time as the smallest meaningful difference. Previously published reports was used to base the
      sample size calculation, using a success rate of 82% and 60% for first attempt at video
      laryngoscopy and direct laryngoscopy, respectively. An estimated sample size of 48 patients
      (24 in each arm) will be needed to detect a difference of 10% in first attempt success rate
      between the groups with an 80% power and alpha level of 0.05. [A previously published study
      (Rabrizi et al 2018) assessed first attempt success rate in patients with bilateral
      mandibular fractures in Glidescope video laryngoscopy versus Macintosh laryngoscopy. They
      found a first attempt success rate of 82% using a video laryngoscopy versus 60% using direct
      laryngoscopy.] Data Collection and Analysis To organize data collection, a Microsoft Excel
      spreadsheet will be created and used to record information, which will be kept on a secured
      LSU drive which only the investigators have access to. Data will be compiled and imported
      into JMP Statistical Discovery for analysis (JMP, Version 12.1. SAS Institute Inc., Cary, NC,
      1989-2015). The relationship of the primary outcome variable to the primary predictor will be
      analyzed using Chi squared tests. The relationship of the secondary outcome variables to the
      primary predictor will be analyzed using Chi squared tests and t tests, as appropriate for
      the data type. Study variables will be examined for their relationship to the primary
      predictor and primary outcome using t test, Chi squared test and ANOVA as appropriate for the
      type of variable. A p-value of less than 0.05 will be considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: success of first attempt intubation
time frame: 1 day
description: defined as confirmed placement of the endotracheal tube by bilateral breath sounds, end-tidal CO2 waveform and lack of cuff leak
measure: amount of time required to secure the nasotracheal tube
time frame: 1 day
description: amount of time required to secure the nasotracheal tube
measure: the use of Macgill forceps
time frame: 1 day
description: the use of Macgill forceps
measure: success at first attempt
time frame: 1 day
description: success at first attempt
measure: number of attempts
time frame: 1 day
description: number of attempts
measure: number of endotracheal tube exchanges after placement
time frame: 1 day
description: number of endotracheal tube exchanges after placement
measure: number of torn endotracheal tube cuffs
time frame: 1 day
description: number of torn endotracheal tube cuffs
measure: Cormack-Lehane score
time frame: 1 day
description: Cormack-Lehane score
arm group label: Video Laryngoscopy
arm group type: Experimental
arm group label: Direct Laryngoscopy
arm group type: Active Comparator
intervention type: Procedure
intervention name: Video Laryngoscopy
description: The direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx.
arm group label: Video Laryngoscopy
intervention type: Procedure
intervention name: Direct Laryngoscopy
description: The video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.
arm group label: Direct Laryngoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: Brett King
investigator title: Assistant Professor
sharing ipd: No