<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/NCT02234401</url>
  </required_header>
  <id_info>
    <org_study_id>1199</org_study_id>
    <nct_id>NCT02234401</nct_id>
  </id_info>
  <brief_title>Non Invasive Ventilation for Acute Exacerbations in Adult CF</brief_title>
  <acronym>NIVinCF</acronym>
  <official_title>A Mixed Methods Study Comparing the Clinical Efficacy With the Patient Experience of Non-invasive Ventilation During an Acute Exacerbation Complicated by Respiratory Failure in Adult Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Manchester Metropolitan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years&#xD;
      (UK CF Registry 2011). The commonest cause of death is respiratory failure.&#xD;
&#xD;
      Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the&#xD;
      size and depth of each breath. It is introduced in CF to manage established respiratory&#xD;
      failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation,&#xD;
      is used just at night, or for part of the day in addition or for 24 hours as clinical status&#xD;
      indicates. It is introduced within a normal ward environment and then continued longterm at&#xD;
      home.Once respiratory failure is established longterm noninvasive ventilation is introduced&#xD;
      throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate&#xD;
      for the individual.&#xD;
&#xD;
      This study aims to evaluate a potential development of current practice: the use of non&#xD;
      invasive ventilation during hospital admission only to enhance recovery from an acute&#xD;
      exacerbation which has caused respiratory failure in those individuals where long term non&#xD;
      invasive ventilation is not yet indicated. A mixed methods design will allow description of&#xD;
      the experience of noninvasive ventilation during a semistructured interview to add to&#xD;
      understanding of the results from an experiment designed to measure the differences between&#xD;
      noninvasive ventilation and standard care.&#xD;
&#xD;
      Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an&#xD;
      acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: The study will use a mixed methodology and it will be in 2 phases. Phase I A group&#xD;
      randomised controlled trial&#xD;
&#xD;
      The following measurements will be performed on days 1, 3, 7, 10, 14 and twice weekly until&#xD;
      discharge:&#xD;
&#xD;
      The exact timing of measurements will be planned by the participant and the researcher.&#xD;
&#xD;
      All of the outcome measures form part of routine clinical practice except the symptom score;&#xD;
      the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD V2.0) (Goss et al., 2009)&#xD;
&#xD;
        1. Early morning and day time carbon dioxide (CO2) level.&#xD;
&#xD;
        2. Day time oxygen levels&#xD;
&#xD;
        3. Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity&#xD;
           (FVC)&#xD;
&#xD;
        4. Day time resting Respiratory Rate (RR), Heart Rate (HR)&#xD;
&#xD;
        5. Symptom score CFRSD&#xD;
&#xD;
      Phase II A qualitative exploration of the experience of using NIV for adults with Cystic&#xD;
      Fibrosis during an acute exacerbation&#xD;
&#xD;
      Methods: Prior to discharge a semistructured interview designed to explore the experience of&#xD;
      using noninvasive ventilation will be undertaken by a clinical psychologist from the Cystic&#xD;
      Fibrosis multidisciplinary team. The interviews will be undertaken purely for the research&#xD;
      project, recorded and transcribed verbatim by the lead investigator. Thematic analysis will&#xD;
      be undertaken to interpret and explore the individual's experience. Credibility checking of&#xD;
      interpretation will be undertaken by the clinical psychologists and within academic&#xD;
      supervision sessions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in day time carbon dioxide (CO2)</measure>
    <time_frame>Day 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early morning oxygen (O2) and CO2 levels</measure>
    <time_frame>days 1,3,5,7,10 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function (FEV1 and FVC)</measure>
    <time_frame>Day 7, 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>days 1,3,5,7,10 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Days 1,3,5,7,10 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom score (CFRSD)</measure>
    <time_frame>days 1,3,5,7,10 and 14</time_frame>
    <description>Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Semi structured interview</measure>
    <time_frame>Day 14</time_frame>
    <description>Psychologist delivered semi structured interview discussing participant experience of non invasive ventilation (NIV)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Cystic Fibrosis</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Non invasive ventilation (NIV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non invasive ventilation used for the first 7 days of study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High Flow Controlled Oxygen Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bi level pressure support</intervention_name>
    <arm_group_label>Non invasive ventilation (NIV)</arm_group_label>
    <other_name>Noninvasive ventilation</other_name>
    <other_name>NIV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Cystic Fibrosis&#xD;
&#xD;
          -  Hospital admission to Pearce Ward Manchester Adult Cystic Fibrosis Centre&#xD;
&#xD;
          -  Acute respiratory exacerbation conforming with a standard definition of pulmonary&#xD;
             exacerbation (Fuchs et al 1994).&#xD;
&#xD;
          -  An admission day time CO2 &gt; 6 kilopascal (kPa) on standard therapy&#xD;
&#xD;
          -  Freely given informed consent.-&#xD;
&#xD;
          -  24.3.15 substantial amendment approval for an admission early morning CO2 &gt; 6 kPa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A day time CO2 &gt;8.0 kPa&#xD;
&#xD;
          -  respiratory acidosis&#xD;
&#xD;
          -  clinical exclusion by CF consultant physician or clinical psychologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan C Johnson, MSC MCSP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susan C Johnson, MSc MCSP</last_name>
    <phone>0161291</phone>
    <phone_ext>5007</phone_ext>
    <email>susan.johnson@uhsm.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rowland BrightThomas, MB ChB, MRCP, MD</last_name>
    <phone>0161291</phone>
    <phone_ext>5007</phone_ext>
    <email>Rowland.brighthomas@uhsm.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester</name>
      <address>
        <city>Wythenshawe</city>
        <state>Manchester</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Susan C Johnson, MSc MCSP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Manchester Metropolitan University</investigator_affiliation>
    <investigator_full_name>Susan C Johnson</investigator_full_name>
    <investigator_title>Consultant Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Noninvasive ventilation</keyword>
  <keyword>Non invasive ventilation</keyword>
  <keyword>Acute respiratory exacerbation</keyword>
  <keyword>Bi level pressure support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02234401
org study id: 1199
nct id: NCT02234401
lead sponsor: 
collaborator: 
has dmc: No
Cystic Fibrosis (CF) is a life limiting illness. Median predicted UK survival is 41.4 years
      (UK CF Registry 2011). The commonest cause of death is respiratory failure.

      Non invasive ventilation (NIV) is a system which delivers a preset pressure to supplement the
      size and depth of each breath. It is introduced in CF to manage established respiratory
      failure. A nose or a mask which covers both the nose and mouth allows flexible ventilation,
      is used just at night, or for part of the day in addition or for 24 hours as clinical status
      indicates. It is introduced within a normal ward environment and then continued longterm at
      home.Once respiratory failure is established longterm noninvasive ventilation is introduced
      throughout 24 hours and multidisciplinary assessment concludes that the timing is appropriate
      for the individual.

      This study aims to evaluate a potential development of current practice: the use of non
      invasive ventilation during hospital admission only to enhance recovery from an acute
      exacerbation which has caused respiratory failure in those individuals where long term non
      invasive ventilation is not yet indicated. A mixed methods design will allow description of
      the experience of noninvasive ventilation during a semistructured interview to add to
      understanding of the results from an experiment designed to measure the differences between
      noninvasive ventilation and standard care.

      Aim: To compare the clinical efficacy with the patient experience of NIV on recovery from an
      acute respiratory exacerbation complicated by respiratory failure in adult Cystic Fibrosis.
Design: The study will use a mixed methodology and it will be in 2 phases. Phase I A group
      randomised controlled trial

      The following measurements will be performed on days 1, 3, 7, 10, 14 and twice weekly until
      discharge:

      The exact timing of measurements will be planned by the participant and the researcher.

      All of the outcome measures form part of routine clinical practice except the symptom score;
      the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD V2.0) (Goss et al., 2009)

        1. Early morning and day time carbon dioxide (CO2) level.

        2. Day time oxygen levels

        3. Lung function Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity
           (FVC)

        4. Day time resting Respiratory Rate (RR), Heart Rate (HR)

        5. Symptom score CFRSD

      Phase II A qualitative exploration of the experience of using NIV for adults with Cystic
      Fibrosis during an acute exacerbation

      Methods: Prior to discharge a semistructured interview designed to explore the experience of
      using noninvasive ventilation will be undertaken by a clinical psychologist from the Cystic
      Fibrosis multidisciplinary team. The interviews will be undertaken purely for the research
      project, recorded and transcribed verbatim by the lead investigator. Thematic analysis will
      be undertaken to interpret and explore the individual's experience. Credibility checking of
      interpretation will be undertaken by the clinical psychologists and within academic
      supervision sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in day time carbon dioxide (CO2)
time frame: Day 7
measure: Early morning oxygen (O2) and CO2 levels
time frame: days 1,3,5,7,10 and 14
measure: Lung function (FEV1 and FVC)
time frame: Day 7, 14
measure: Respiratory Rate
time frame: days 1,3,5,7,10 and 14
measure: Heart Rate
time frame: Days 1,3,5,7,10 and 14
measure: Symptom score (CFRSD)
time frame: days 1,3,5,7,10 and 14
description: Cystic Fibrosis Respiratory Symptom Diary (Daily Recall)
measure: Semi structured interview
time frame: Day 14
description: Psychologist delivered semi structured interview discussing participant experience of non invasive ventilation (NIV)
arm group label: Non invasive ventilation (NIV)
arm group type: Experimental
description: Non invasive ventilation used for the first 7 days of study
arm group label: Standard Care
arm group type: Active Comparator
description: High Flow Controlled Oxygen Therapy
intervention type: Device
intervention name: Bi level pressure support
arm group label: Non invasive ventilation (NIV)
other name: Noninvasive ventilation
other name: NIV
intervention type: Other
intervention name: Standard Care
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan C Johnson, MSC MCSP
role: Principal Investigator
affiliation: Manchester Adult Cystic Fibrosis Centre, University Hospitals South Manchester
last name: Susan C Johnson, MSc MCSP
phone: 0161291
phone ext: 5007
email: susan.johnson@uhsm.nhs.uk
last name: Rowland BrightThomas, MB ChB, MRCP, MD
phone: 0161291
phone ext: 5007
email: Rowland.brighthomas@uhsm.nhs.uk
facility: 
status: Recruiting
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Manchester Metropolitan University
investigator full name: Susan C Johnson
investigator title: Consultant Physiotherapist
mesh term: Cystic Fibrosis
mesh term: Respiratory Insufficiency
mesh term: Fibrosis