<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/NCT02248064</url>
  </required_header>
  <id_info>
    <org_study_id>14IC1995</org_study_id>
    <nct_id>NCT02248064</nct_id>
  </id_info>
  <brief_title>Auto-titrating Oxygen in Chronic Respiratory Failure</brief_title>
  <acronym>ASI1</acronym>
  <official_title>The Assessment of Intelligent Oxygen Therapy (iO2t) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive&#xD;
      pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home,&#xD;
      from time to time patients still have low oxygen levels especially when walking which can be&#xD;
      harmful.&#xD;
&#xD;
      The investigators have designed a new system of delivering oxygen to overcome the above&#xD;
      problem. The system measures the oxygen saturations of a patient and subsequently adjust the&#xD;
      flow of oxygen to meet a pre-set oxygen saturation target.&#xD;
&#xD;
      Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low&#xD;
      levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with&#xD;
      chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary&#xD;
      fibrosis (IPF), disease progression leads to hypoxic respiratory failure necessitating the&#xD;
      use of long-term oxygen therapy (LTOT). However a number of studies have shown that despite&#xD;
      being on LTOT at home many patients with COPD still experience episodes of intermittent&#xD;
      hypoxia (reduction in oxygen saturation &lt;90%). These episodes occur during rest, sleep,&#xD;
      talking, walking and sleep. These episodes of intermittent hypoxia can be harmful as they can&#xD;
      lead to the development of ischaemic heart disease, induce pulmonary hypertension and affect&#xD;
      brain function.&#xD;
&#xD;
      In order to reduce these episodes of intermittent hypoxia, the investigators have designed an&#xD;
      auto-titrating, closed-loop oxygen system which automatically adjust the flow of oxygen to&#xD;
      match a given oxygen saturation target. This allows individualisation and optimisation of&#xD;
      oxygen therapy for every patient.&#xD;
&#xD;
      Mechanism of action:&#xD;
&#xD;
      A pulse oximeter is attached to the ear or finger of a patient. This send the oxygen&#xD;
      saturation reading to a control centre (located in a mobile phone). The control centre is&#xD;
      pre-programmed to maintain a set oxygen saturation target. The control centre outputs a&#xD;
      signal to a flow meter which regulated the outflow of oxygen.&#xD;
&#xD;
      In this study, the investigators will recruit patients with COPD on LTOT and patients with&#xD;
      IPF on LTOT or ambulatory oxygen to undergo three 6 minute walk tests (6MWT). The first will&#xD;
      be on air (practice walk), the second will be on their usual ambulatory oxygen and the third&#xD;
      on the auto-titrating oxygen system. The order of the second and third walks be randomly&#xD;
      selected. The patient will be blinded as to which type of oxygen they will be receiving in&#xD;
      the second and third walk.&#xD;
&#xD;
      Hypothesis: the investigators iO2t system is better at preventing and treating oxygen&#xD;
      desaturations that occur during a 6MWT than usual fixed flow ambulatory oxygen therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of time spent with oxygen saturation below 90%</measure>
    <time_frame>Assessed at the completion of the 6 minute walk test/s</time_frame>
    <description>The participants complete three 6 minute walk tests. There is continuous oxygen saturation monitoring throughout the walk. At the completion of the walk, the percentage of time spent below an oxgen saturation of 90% is calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total distance walked</measure>
    <time_frame>Assessed at the completion of the 6 minute walk test</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean oxygen saturation</measure>
    <time_frame>Assessed during the 6MWT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Volume of oxygen delivered</measure>
    <time_frame>Assessed at the completion of the 6 minute walk test</time_frame>
    <description>The system records the outflow of oxygen every second. From this data, I can calculate the total volume of oxygen delivered to the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Fixed flow oxygen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auto-titrating arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 6MWT will done using the auto-titrating oxygen system in this arm of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Auto-titrating oxygen system</intervention_name>
    <description>The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.</description>
    <arm_group_label>Auto-titrating arm</arm_group_label>
    <other_name>Intelligent oxygen therapy</other_name>
    <other_name>iO2t</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD and on LTOT&#xD;
&#xD;
          -  IPF on LTOT or ambulatory oxgen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to mobilise for a 6 minute walk test&#xD;
&#xD;
          -  Unable to consent to study,&#xD;
&#xD;
          -  Partial pressure of oxygen &lt; 6.0 kilopascals (kPa) or Partial pressure of carbon&#xD;
             dioxide &gt; 8kilopascals on air,&#xD;
&#xD;
          -  Exacerbation of the underlying lung disease in the previous 4 weeks&#xD;
&#xD;
          -  Unstable cardiovascular disease (e.g. arrhythmia, hypertension/hypotension or angina)&#xD;
&#xD;
          -  Pregnancy&#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>Anita K Simonds, MBBS MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Brompton and Harefield NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Sliwinski P, Lagosz M, Gorecka D, Zielinski J. The adequacy of oxygenation in COPD patients undergoing long-term oxygen therapy assessed by pulse oximetry at home. Eur Respir J. 1994 Feb;7(2):274-8. doi: 10.1183/09031936.94.07020274.</citation>
    <PMID>8162980</PMID>
  </reference>
  <reference>
    <citation>Plywaczewski R, Sliwinski P, Nowinski A, Kaminski D, Zielinski J. Incidence of nocturnal desaturation while breathing oxygen in COPD patients undergoing long-term oxygen therapy. Chest. 2000 Mar;117(3):679-83. doi: 10.1378/chest.117.3.679.</citation>
    <PMID>10712991</PMID>
  </reference>
  <reference>
    <citation>Morrison D, Skwarski KM, MacNee W. The adequacy of oxygenation in patients with hypoxic chronic obstructive pulmonary disease treated with long-term domiciliary oxygen. Respir Med. 1997 May;91(5):287-91. doi: 10.1016/s0954-6111(97)90032-9. Erratum In: Respir Med 1997 Aug;91(7):442.</citation>
    <PMID>9176647</PMID>
  </reference>
  <reference>
    <citation>Selinger SR, Kennedy TP, Buescher P, Terry P, Parham W, Gofreed D, Medinger A, Spagnolo SV, Michael JR. Effects of removing oxygen from patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Jul;136(1):85-91. doi: 10.1164/ajrccm/136.1.85.</citation>
    <PMID>3605848</PMID>
  </reference>
  <reference>
    <citation>Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.</citation>
    <PMID>6776858</PMID>
  </reference>
  <reference>
    <citation>Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.</citation>
    <PMID>6110912</PMID>
  </reference>
  <reference>
    <citation>Choudhury G, Rabinovich R, MacNee W. Comorbidities and systemic effects of chronic obstructive pulmonary disease. Clin Chest Med. 2014 Mar;35(1):101-30. doi: 10.1016/j.ccm.2013.10.007.</citation>
    <PMID>24507840</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>February 15, 2016</last_update_submitted>
  <last_update_submitted_qc>February 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>Long term oxygen therapy</keyword>
  <keyword>Auto-titrating oxygen system</keyword>
  <keyword>Intelligent oxygen therapy</keyword>
  <keyword>Idiopathic pulmonary fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 13, 2022</submitted>
    <returned>March 11, 2022</returned>
  </pending_results>
  <!-- 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/NCT02248064
org study id: 14IC1995
nct id: NCT02248064
lead sponsor: 
has dmc: No
Long term oxygen therapy (LTOT) increases the life span of patients with chronic obstructive
      pulmonary disease who have low oxygen levels. However, even when on oxygen therapy at home,
      from time to time patients still have low oxygen levels especially when walking which can be
      harmful.

      The investigators have designed a new system of delivering oxygen to overcome the above
      problem. The system measures the oxygen saturations of a patient and subsequently adjust the
      flow of oxygen to meet a pre-set oxygen saturation target.

      Hypothesis: the investigators intelligent oxygen therapy system is better at reducing low
      levels of oxygen during a 6 minute walk than usual ambulatory oxygen for patients with
      chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis.
For patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary
      fibrosis (IPF), disease progression leads to hypoxic respiratory failure necessitating the
      use of long-term oxygen therapy (LTOT). However a number of studies have shown that despite
      being on LTOT at home many patients with COPD still experience episodes of intermittent
      hypoxia (reduction in oxygen saturation <90%). These episodes occur during rest, sleep,
      talking, walking and sleep. These episodes of intermittent hypoxia can be harmful as they can
      lead to the development of ischaemic heart disease, induce pulmonary hypertension and affect
      brain function.

      In order to reduce these episodes of intermittent hypoxia, the investigators have designed an
      auto-titrating, closed-loop oxygen system which automatically adjust the flow of oxygen to
      match a given oxygen saturation target. This allows individualisation and optimisation of
      oxygen therapy for every patient.

      Mechanism of action:

      A pulse oximeter is attached to the ear or finger of a patient. This send the oxygen
      saturation reading to a control centre (located in a mobile phone). The control centre is
      pre-programmed to maintain a set oxygen saturation target. The control centre outputs a
      signal to a flow meter which regulated the outflow of oxygen.

      In this study, the investigators will recruit patients with COPD on LTOT and patients with
      IPF on LTOT or ambulatory oxygen to undergo three 6 minute walk tests (6MWT). The first will
      be on air (practice walk), the second will be on their usual ambulatory oxygen and the third
      on the auto-titrating oxygen system. The order of the second and third walks be randomly
      selected. The patient will be blinded as to which type of oxygen they will be receiving in
      the second and third walk.

      Hypothesis: the investigators iO2t system is better at preventing and treating oxygen
      desaturations that occur during a 6MWT than usual fixed flow ambulatory oxygen therapy
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Investigator)
measure: The percentage of time spent with oxygen saturation below 90%
time frame: Assessed at the completion of the 6 minute walk test/s
description: The participants complete three 6 minute walk tests. There is continuous oxygen saturation monitoring throughout the walk. At the completion of the walk, the percentage of time spent below an oxgen saturation of 90% is calculated
measure: Total distance walked
time frame: Assessed at the completion of the 6 minute walk test
measure: Mean oxygen saturation
time frame: Assessed during the 6MWT
measure: Total Volume of oxygen delivered
time frame: Assessed at the completion of the 6 minute walk test
description: The system records the outflow of oxygen every second. From this data, I can calculate the total volume of oxygen delivered to the patient.
arm group label: Fixed flow oxygen
arm group type: No Intervention
description: The 6MWT will done on the patients usual fixed flow ambulatory oxygen in this arm.
arm group label: Auto-titrating arm
arm group type: Experimental
description: The 6MWT will done using the auto-titrating oxygen system in this arm of the study
intervention type: Device
intervention name: Auto-titrating oxygen system
description: The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.
arm group label: Auto-titrating arm
other name: Intelligent oxygen therapy
other name: iO2t
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anita K Simonds, MBBS MD FRCP
role: Principal Investigator
affiliation: Royal Brompton & Harefield NHS Foundation Trust
facility: 
country: United Kingdom
citation: Sliwinski P, Lagosz M, Gorecka D, Zielinski J. The adequacy of oxygenation in COPD patients undergoing long-term oxygen therapy assessed by pulse oximetry at home. Eur Respir J. 1994 Feb;7(2):274-8. doi: 10.1183/09031936.94.07020274.
PMID: 8162980
citation: Plywaczewski R, Sliwinski P, Nowinski A, Kaminski D, Zielinski J. Incidence of nocturnal desaturation while breathing oxygen in COPD patients undergoing long-term oxygen therapy. Chest. 2000 Mar;117(3):679-83. doi: 10.1378/chest.117.3.679.
PMID: 10712991
citation: Morrison D, Skwarski KM, MacNee W. The adequacy of oxygenation in patients with hypoxic chronic obstructive pulmonary disease treated with long-term domiciliary oxygen. Respir Med. 1997 May;91(5):287-91. doi: 10.1016/s0954-6111(97)90032-9. Erratum In: Respir Med 1997 Aug;91(7):442.
PMID: 9176647
citation: Selinger SR, Kennedy TP, Buescher P, Terry P, Parham W, Gofreed D, Medinger A, Spagnolo SV, Michael JR. Effects of removing oxygen from patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Jul;136(1):85-91. doi: 10.1164/ajrccm/136.1.85.
PMID: 3605848
citation: Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.
PMID: 6776858
citation: Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.
PMID: 6110912
citation: Choudhury G, Rabinovich R, MacNee W. Comorbidities and systemic effects of chronic obstructive pulmonary disease. Clin Chest Med. 2014 Mar;35(1):101-30. doi: 10.1016/j.ccm.2013.10.007.
PMID: 24507840
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: No
submitted: January 13, 2022
returned: March 11, 2022