<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/NCT03824223</url>
  </required_header>
  <id_info>
    <org_study_id>17IA16</org_study_id>
    <nct_id>NCT03824223</nct_id>
  </id_info>
  <brief_title>'Fitness To Fly' Tests In Children With Type II Respiratory Failure</brief_title>
  <official_title>'Fitness To Fly' Testing In Children With Neuromuscular Weakness Or Central Hypoventilation: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Great Ormond Street Hospital for Children 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>
      The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in&#xD;
      all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied.&#xD;
      Th investigators will study children who have either neuromuscular weakness or central&#xD;
      hypoventilation and who require nocturnal or intermittent daytime ventilator support.&#xD;
&#xD;
      The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing&#xD;
      the standard hypoxic standard test to a modified test designed to better suit children with&#xD;
      type two respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2)&#xD;
      and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified&#xD;
      Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central&#xD;
      hypoventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proof of concept outcome 1</measure>
    <time_frame>during hypoxic challenge test</time_frame>
    <description>number of children/infants with SpO2 &lt;90/85%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>proof of concept outcome 2</measure>
    <time_frame>during hypoxic challenge test</time_frame>
    <description>number of children with &gt;15 mmHg rise in TcCO2/EtCO2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility outcome 1: recruitment rate</measure>
    <time_frame>one year</time_frame>
    <description>recruitment rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility outcome 2: protocol completion rate</measure>
    <time_frame>one year</time_frame>
    <description>protocol completion rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <condition>Central Hypoventilation</condition>
  <arm_group>
    <arm_group_label>new/old HCT component order</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>new/old hypoxic challenge test (HCT) component order&#xD;
Where the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen and the old test uses pulse oximetry to titrate supplementary oxygen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>old/new HCT component order</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>old/new hypoxic challenge test (HCT) component order&#xD;
Where the old test uses pulse oximetry to titrate supplementary oxygen and the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hypoxic challenge test</intervention_name>
    <description>Physiological response to 15% ambient oxygen monitored.</description>
    <arm_group_label>new/old HCT component order</arm_group_label>
    <arm_group_label>old/new HCT component order</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≤18 years&#xD;
&#xD;
          -  Neuromuscular weakness or central hypoventilation&#xD;
&#xD;
          -  Established nocturnal or intermittent daytime ventilatory support&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to sit in the plethysmograph&#xD;
&#xD;
          -  Cardiac anomaly with right-to-left shunt&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katharine C Pike, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Ormond Street Hospital for Children NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</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>Hypoventilation</mesh_term>
    <mesh_term>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03824223
org study id: 17IA16
nct id: NCT03824223
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in
      all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied.
      Th investigators will study children who have either neuromuscular weakness or central
      hypoventilation and who require nocturnal or intermittent daytime ventilator support.

      The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing
      the standard hypoxic standard test to a modified test designed to better suit children with
      type two respiratory failure.
This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2)
      and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified
      Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central
      hypoventilation.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants randomised to uniform balanced crossover (new/old or old/new hypoxic challenge test components).
primary purpose: Other
masking: None (Open Label)
measure: proof of concept outcome 1
time frame: during hypoxic challenge test
description: number of children/infants with SpO2 <90/85%
measure: proof of concept outcome 2
time frame: during hypoxic challenge test
description: number of children with >15 mmHg rise in TcCO2/EtCO2
measure: Feasibility outcome 1: recruitment rate
time frame: one year
description: recruitment rate
measure: Feasibility outcome 2: protocol completion rate
time frame: one year
description: protocol completion rate
arm group label: new/old HCT component order
arm group type: Other
description: new/old hypoxic challenge test (HCT) component order
Where the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen and the old test uses pulse oximetry to titrate supplementary oxygen.
arm group label: old/new HCT component order
arm group type: Other
description: old/new hypoxic challenge test (HCT) component order
Where the old test uses pulse oximetry to titrate supplementary oxygen and the new test uses pulse oximetry and transcutaneous CO2 monitoring to guide use of ventilatory support and if necessary supplementary oxygen.
intervention type: Diagnostic Test
intervention name: Hypoxic challenge test
description: Physiological response to 15% ambient oxygen monitored.
arm group label: new/old HCT component order
arm group label: old/new HCT component order
criteria: 
gender: All
minimum age: 0 Years
maximum age: 18 Years
healthy volunteers: No
last name: Katharine C Pike, PhD
role: Principal Investigator
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypoventilation
mesh term: Neuromuscular Diseases
sharing ipd: Undecided