<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/NCT03265548</url>
  </required_header>
  <id_info>
    <org_study_id>16/SW/0013</org_study_id>
    <nct_id>NCT03265548</nct_id>
  </id_info>
  <brief_title>Video Laryngoscopy in Newborn Babies V1</brief_title>
  <official_title>Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Devon and Exeter NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Derriford Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Devon and Exeter NHS Foundation Trust</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>
      Our research questions are&#xD;
&#xD;
        1. Will the use of a video laryngoscope lead to decreased attempts&#xD;
&#xD;
        2. Does this result in more successful intubations and greater confidence in the supervisor&#xD;
           and the team that a successful intubation has been performed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neonatal intubation is a technically difficult, but essential, skill to learn, involving&#xD;
      passing a plastic tube through the vocal cords, into the trachea. Current practice involves&#xD;
      using a laryngoscope to directly visualise the cords, however this technique does not allow&#xD;
      the supervisor to witness the tube passing through the cords. Video laryngoscopes have a&#xD;
      camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that&#xD;
      is seen with direct view. In addition, the image is projected onto a screen, allowing all&#xD;
      members of the team to visualise the intubation and therefore provide real time guidance as&#xD;
      well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in&#xD;
      neonates in other specialities, for example Ear Nose and throat or respiratory physicians,&#xD;
      and are becoming routinely used by neonatologists. The research questions are whether using a&#xD;
      video laryngoscope will lead to decreased attempts, which in turn will potentially result in&#xD;
      more successful intubations and greater confidence in the supervisor and the team that a&#xD;
      successful intubation has been performed.&#xD;
&#xD;
      The aim is to recruit 40 babies and randomly allocate the participant to either direct&#xD;
      laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful&#xD;
      intubation would be recorded, in addition to confidence of supervisor and the team regarding&#xD;
      the outcome of the attempt.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of attempts to successful intubation</measure>
    <time_frame>Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation</time_frame>
    <description>How many attempts before successful intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Team confidence around tube placement at the time of tube placement</measure>
    <time_frame>immediately after the intubation</time_frame>
    <description>Continuous line to score the confidence of the individuals in the team</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Direct view laryngoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video laryngoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Video Laryngoscope</intervention_name>
    <description>The use of video laryngoscopy</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any baby requiring intubation on a neonatal unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants will not be recruited if they are in extremis requiring immediate intubation&#xD;
             by a senior experienced operator who will use his/her own preferred method. Infants&#xD;
             who will be intubated nasally will not be included as this technique is not usually&#xD;
             taught to registrars.&#xD;
&#xD;
        Any baby with a congenital airway malformation will not be included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bartle Dr David, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant at Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Devon and Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX25DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</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/NCT03265548
org study id: 16/SW/0013
nct id: NCT03265548
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Our research questions are

        1. Will the use of a video laryngoscope lead to decreased attempts

        2. Does this result in more successful intubations and greater confidence in the supervisor
           and the team that a successful intubation has been performed.
Neonatal intubation is a technically difficult, but essential, skill to learn, involving
      passing a plastic tube through the vocal cords, into the trachea. Current practice involves
      using a laryngoscope to directly visualise the cords, however this technique does not allow
      the supervisor to witness the tube passing through the cords. Video laryngoscopes have a
      camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that
      is seen with direct view. In addition, the image is projected onto a screen, allowing all
      members of the team to visualise the intubation and therefore provide real time guidance as
      well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in
      neonates in other specialities, for example Ear Nose and throat or respiratory physicians,
      and are becoming routinely used by neonatologists. The research questions are whether using a
      video laryngoscope will lead to decreased attempts, which in turn will potentially result in
      more successful intubations and greater confidence in the supervisor and the team that a
      successful intubation has been performed.

      The aim is to recruit 40 babies and randomly allocate the participant to either direct
      laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful
      intubation would be recorded, in addition to confidence of supervisor and the team regarding
      the outcome of the attempt.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Number of attempts to successful intubation
time frame: Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation
description: How many attempts before successful intubation
measure: Team confidence around tube placement at the time of tube placement
time frame: immediately after the intubation
description: Continuous line to score the confidence of the individuals in the team
arm group label: Standard
arm group type: No Intervention
description: Usual Direct view laryngoscopy
arm group label: Intervention
arm group type: Experimental
description: Video laryngoscopy
intervention type: Device
intervention name: Video Laryngoscope
description: The use of video laryngoscopy
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bartle Dr David, MBChB
role: Principal Investigator
affiliation: Consultant at Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
sharing ipd: No