<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/NCT03238950</url>
  </required_header>
  <id_info>
    <org_study_id>2017SUR96</org_study_id>
    <nct_id>NCT03238950</nct_id>
  </id_info>
  <brief_title>Cricothyroidotomy Training for Physicians Outcomes Study</brief_title>
  <official_title>In Cricothyroidotomy Training for Physicians Does Simulated Practice With Tissue Specimens Produce Better Outcomes Than Using Synthetics Manikins?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Royal Wolverhampton Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Royal Wolverhampton Hospitals NHS 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>
      This study will assess whether the type of simulation model used in cricothyroidotomy&#xD;
      training has an effect on the subsequent confidence and competence in the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Pilot study - prospective randomised controlled trial involving:&#xD;
&#xD;
        1. Assessment of ability to complete a surgical cricothyroidotomy&#xD;
&#xD;
        2. Completion of questionnaire prior to training and prior to assessment&#xD;
&#xD;
      Prior to beginning training, questionnaires will be completed by all participants asking&#xD;
      their level of previous training. Current confidence level for completion of&#xD;
      cricothyroidotomy will be marked on a visual analogue scale (VAS).&#xD;
&#xD;
      Training will then be completed with each group using the appropriate manikin type - porcine&#xD;
      or synthetic. This will consist of didactic information on the procedure delivered via&#xD;
      recorded information to standardise this initial training, and then proceeding to supervised&#xD;
      practice of the procedure for two occasions. This will be completed by the same trainer, with&#xD;
      the same information given to both groups. Questions to clarify how to perform the procedure&#xD;
      will be permitted.&#xD;
&#xD;
      The second questionnaire will be given to the trainees on completion of training to mark on a&#xD;
      visual analogue scale their confidence level at this point.&#xD;
&#xD;
      Assessment will then be completed later the day comprising of assessment of completion of&#xD;
      surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be&#xD;
      different to the porcine manikin used for training. The assessment will time the trainees&#xD;
      from start to completion of airway insertion, as well as a checklist of activities to be&#xD;
      achieved. The porcine manikins will then be dissected to identify if correct location for&#xD;
      insertion was achieved and complications. The same amount of time will be given between&#xD;
      groups training and assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study has never actually started as waiting on funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.</measure>
    <time_frame>1 day</time_frame>
    <description>time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success rate for cricothyroidotomy</measure>
    <time_frame>1 day</time_frame>
    <description>subjective reporting of confidence through questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate for cricothyroidotomy</measure>
    <time_frame>1 day</time_frame>
    <description>subjective reporting of confidence through questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>Porcine Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Training conducted on Porcine model</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Synthetic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Training conducted on synthetic model</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Porcine model</intervention_name>
    <description>participants to conduct training on porcine model</description>
    <arm_group_label>Porcine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Synthetic model</intervention_name>
    <description>participants to conduct training on synthetic model</description>
    <arm_group_label>Synthetic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically trained healthcare professionals working in Anaesthetics, Emergency Medicine&#xD;
             or General Surgery as these doctors may be expected to complete a surgical&#xD;
             cricothyroidotomy despite infrequently performing the procedure.&#xD;
&#xD;
          -  The healthcare professionals can be from Foundation Year 1 to before Certificates of&#xD;
             Completion of Training (CCT). Those who are out of training and are not yet at&#xD;
             consultant level are also eligible.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Healthcare professionals who already complete surgical airways on a regular basis (e.g.&#xD;
        Ear Nose Throat or Maxillofacial trainees) as these doctors may already be competent prior&#xD;
        to training.&#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>Michael Helme</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Royal Wolverhampton NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Wolverhampton NHS Trust</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>Airway Obstruction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan</ipd_description>
  </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/NCT03238950
org study id: 2017SUR96
nct id: NCT03238950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess whether the type of simulation model used in cricothyroidotomy
      training has an effect on the subsequent confidence and competence in the procedure.
This is a Pilot study - prospective randomised controlled trial involving:

        1. Assessment of ability to complete a surgical cricothyroidotomy

        2. Completion of questionnaire prior to training and prior to assessment

      Prior to beginning training, questionnaires will be completed by all participants asking
      their level of previous training. Current confidence level for completion of
      cricothyroidotomy will be marked on a visual analogue scale (VAS).

      Training will then be completed with each group using the appropriate manikin type - porcine
      or synthetic. This will consist of didactic information on the procedure delivered via
      recorded information to standardise this initial training, and then proceeding to supervised
      practice of the procedure for two occasions. This will be completed by the same trainer, with
      the same information given to both groups. Questions to clarify how to perform the procedure
      will be permitted.

      The second questionnaire will be given to the trainees on completion of training to mark on a
      visual analogue scale their confidence level at this point.

      Assessment will then be completed later the day comprising of assessment of completion of
      surgical cricothyroidotomy using a porcine manikin with skin overlying. This will be
      different to the porcine manikin used for training. The assessment will time the trainees
      from start to completion of airway insertion, as well as a checklist of activities to be
      achieved. The porcine manikins will then be dissected to identify if correct location for
      insertion was achieved and complications. The same amount of time will be given between
      groups training and assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time to successfully complete surgical cricothyroidotomy on a prepared porcine specimen.
time frame: 1 day
description: time
measure: Success rate for cricothyroidotomy
time frame: 1 day
description: subjective reporting of confidence through questionnaire
measure: Complication rate for cricothyroidotomy
time frame: 1 day
description: subjective reporting of confidence through questionnaire
arm group label: Porcine Group
arm group type: Other
description: Training conducted on Porcine model
arm group label: Synthetic
arm group type: Other
description: Training conducted on synthetic model
intervention type: Other
intervention name: Porcine model
description: participants to conduct training on porcine model
arm group label: Porcine Group
intervention type: Other
intervention name: Synthetic model
description: participants to conduct training on synthetic model
arm group label: Synthetic
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Helme
role: Principal Investigator
affiliation: The Royal Wolverhampton NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Airway Obstruction
sharing ipd: No
ipd description: no plan