<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/NCT03035175</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00051876</org_study_id>
    <nct_id>NCT03035175</nct_id>
  </id_info>
  <brief_title>Using Video Laryngoscopy for Neonatal Intubation</brief_title>
  <official_title>A Randomized Control Trial: Does Guidance Using Video Laryngoscopy Improve Residents' Success in Neonatal Intubation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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>
      This study examines the effectiveness of utilizing video laryngoscopy to give real-time&#xD;
      guidance during neonatal intubations to improve residents' success at performing intubations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate whether residents who receive guidance from a supervisor concurrently viewing the&#xD;
      neonate's airway via video laryngoscopy will have a higher rate of successful neonatal&#xD;
      intubations than residents receiving guidance using traditional direct laryngoscopy.&#xD;
&#xD;
      The investigators conducted a randomized controlled trial involving 48 first and second year&#xD;
      pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or&#xD;
      traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted&#xD;
      intubations in the neonatal intensive care unit according to their randomization group. The&#xD;
      primary outcome was a successful intubation that occurred within two attempts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">June 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Successful Intubations</measure>
    <time_frame>12 months</time_frame>
    <description>A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of successful intubations by resident year</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of residents with successful intubations on the first and subsequent patients</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average length of time of intubation attempts</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of both serious and non-serious adverse events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of successful intubations by residency program</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Education, Medical</condition>
  <arm_group>
    <arm_group_label>Video Laryngoscopy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects enrolled in this arm received real-time guidance from a supervisor utilizing the screen of the video laryngoscope while the subjects performed direct neonatal intubations in the NICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Laryngoscopy Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Laryngoscopy</intervention_name>
    <description>Residents intubate using video laryngoscopy.</description>
    <arm_group_label>Video Laryngoscopy Group</arm_group_label>
    <other_name>Technology-Assisted Instruction</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Laryngoscopy</intervention_name>
    <description>Residents intubate without using video laryngoscopy.</description>
    <arm_group_label>Traditional Laryngoscopy Group</arm_group_label>
    <other_name>Traditional Instruction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of&#xD;
             Rochester&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents who declined participation&#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>Rita Dadiz, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <reference>
    <citation>Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.</citation>
    <PMID>23562374</PMID>
  </reference>
  <reference>
    <citation>Falck AJ, Escobedo MB, Baillargeon JG, Villard LG, Gunkel JH. Proficiency of pediatric residents in performing neonatal endotracheal intubation. Pediatrics. 2003 Dec;112(6 Pt 1):1242-7. doi: 10.1542/peds.112.6.1242.</citation>
    <PMID>14654592</PMID>
  </reference>
  <reference>
    <citation>O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.</citation>
    <PMID>26482669</PMID>
  </reference>
  <reference>
    <citation>Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.</citation>
    <PMID>26908701</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Rita Dadiz</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Residences</keyword>
  <keyword>Video Laryngoscopy</keyword>
  <keyword>Intubations</keyword>
  <keyword>Neonatal</keyword>
  <keyword>NICU</keyword>
  <keyword>neonates</keyword>
  <keyword>Medical Education</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/NCT03035175
org study id: RSRB00051876
nct id: NCT03035175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the effectiveness of utilizing video laryngoscopy to give real-time
      guidance during neonatal intubations to improve residents' success at performing intubations.
To evaluate whether residents who receive guidance from a supervisor concurrently viewing the
      neonate's airway via video laryngoscopy will have a higher rate of successful neonatal
      intubations than residents receiving guidance using traditional direct laryngoscopy.

      The investigators conducted a randomized controlled trial involving 48 first and second year
      pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or
      traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted
      intubations in the neonatal intensive care unit according to their randomization group. The
      primary outcome was a successful intubation that occurred within two attempts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Successful Intubations
time frame: 12 months
description: A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.
measure: Number of successful intubations by resident year
time frame: 12 months
measure: Number of residents with successful intubations on the first and subsequent patients
time frame: 12 months
measure: Average length of time of intubation attempts
time frame: 12 months
measure: Number of both serious and non-serious adverse events
time frame: 12 months
measure: Number of successful intubations by residency program
time frame: 12 months
arm group label: Video Laryngoscopy Group
arm group type: Experimental
description: Subjects enrolled in this arm received real-time guidance from a supervisor utilizing the screen of the video laryngoscope while the subjects performed direct neonatal intubations in the NICU.
arm group label: Traditional Laryngoscopy Group
arm group type: Active Comparator
description: Subjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU.
intervention type: Other
intervention name: Video Laryngoscopy
description: Residents intubate using video laryngoscopy.
arm group label: Video Laryngoscopy Group
other name: Technology-Assisted Instruction
intervention type: Other
intervention name: Traditional Laryngoscopy
description: Residents intubate without using video laryngoscopy.
arm group label: Traditional Laryngoscopy Group
other name: Traditional Instruction
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rita Dadiz, DO
role: Principal Investigator
affiliation: University of Rochester
citation: Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
PMID: 23562374
citation: Falck AJ, Escobedo MB, Baillargeon JG, Villard LG, Gunkel JH. Proficiency of pediatric residents in performing neonatal endotracheal intubation. Pediatrics. 2003 Dec;112(6 Pt 1):1242-7. doi: 10.1542/peds.112.6.1242.
PMID: 14654592
citation: O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
PMID: 26482669
citation: Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.
PMID: 26908701
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Rita Dadiz
investigator title: Associate Professor
sharing ipd: No