<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/NCT02253667</url>
  </required_header>
  <id_info>
    <org_study_id>PalliativeHFONC</org_study_id>
    <nct_id>NCT02253667</nct_id>
  </id_info>
  <brief_title>Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients</brief_title>
  <official_title>Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sao Joao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sao Joao</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and&#xD;
      90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.&#xD;
&#xD;
      Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide,&#xD;
      Heliox 28 and oxygen.&#xD;
&#xD;
      Conventional oxygen supplementation is often used in these patients, but it may be&#xD;
      inadequate, especially if they require high flows (from 30L/min to 120L/min in acute&#xD;
      respiratory failure).&#xD;
&#xD;
      High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen&#xD;
      system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which&#xD;
      generates the gas flow rate up to 55 L/min and a heated humidification system. This&#xD;
      technology may have an important role in reducing respiratory distress in do-not-intubate&#xD;
      patients.&#xD;
&#xD;
      Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing&#xD;
      rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration;&#xD;
      a better matching between patient's inspiratory demand and oxygen flow; generation of a&#xD;
      certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure&#xD;
      and recruitment; improvement of lung and airway mucociliary clearance due to the heated and&#xD;
      humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and&#xD;
      speech.&#xD;
&#xD;
      The investigators hypothesize that patients supported with HFONC need less opioids to&#xD;
      decrease dyspnoea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    One of the investigators left the department, Master Degree in which this study was part of her&#xD;
    thesis. No patients were enrolled.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnoea</measure>
    <time_frame>2 days</time_frame>
    <description>We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioids</measure>
    <time_frame>2 days</time_frame>
    <description>By randomizing the two groups we will be able to compare the total use of opioids.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiologic variables</measure>
    <time_frame>2 days</time_frame>
    <description>The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient comfort</measure>
    <time_frame>2 days</time_frame>
    <description>Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Overall mortality in hospital and at 3 months and 6 months after discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lung Disease</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>HFONC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will use HFONC with FiO2 enough to achieve SpO2&gt;90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional oxygen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will use venturi or reservoir mask with FiO2 enough to achieve SpO2&gt;90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HFONC</intervention_name>
    <arm_group_label>HFONC</arm_group_label>
    <other_name>Optiflow (Fisher&amp;Paykel ™)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional oxygen therapy</intervention_name>
    <arm_group_label>Conventional oxygen</arm_group_label>
    <other_name>Venturi mask</other_name>
    <other_name>Reservoir mask</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients who had end-stage lung disease (lung cancer, pulmonary fibrosis,&#xD;
             COPD, …) - (McCabe score &gt; 3 [&lt;6 months life expectancy] and a Palliative Prognostic&#xD;
             Index score ≥ 4) admitted to hospital because of acute respiratory failure and&#xD;
             distress&#xD;
&#xD;
          -  Had chosen to forego all life support and receiving only palliative care&#xD;
&#xD;
          -  Severe hypoxemia (PaO2/FiO2&lt; 250)&#xD;
&#xD;
          -  At least one of the following: dyspnoea (Borg scale ≥4), signs of respiratory&#xD;
             distress, and respiratory rate greater than 30 beats per min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients had to be competent (Kelly score &lt;4)&#xD;
&#xD;
          -  Refusal of treatment&#xD;
&#xD;
          -  Weak cough reflex&#xD;
&#xD;
          -  Agitation or non-cooperation&#xD;
&#xD;
          -  Uncontrolled cardiac ischemia or arrhythmias&#xD;
&#xD;
          -  Failure of more than two organs&#xD;
&#xD;
          -  Use of opioids within the past 2 weeks&#xD;
&#xD;
          -  Adverse reactions to opioids&#xD;
&#xD;
          -  History of substance misuse&#xD;
&#xD;
          -  Known contraindication for morphine (acute renal failure and recent head injury)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel R Gonçalves, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pulmonology Department, University Hospital São João</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of São João</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sao Joao</investigator_affiliation>
    <investigator_full_name>Miguel R. Goncalves</investigator_full_name>
    <investigator_title>Clinical Professor, PH.D</investigator_title>
  </responsible_party>
  <keyword>Palliative care</keyword>
  <keyword>Lung disease</keyword>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>High-flow oxygen nasal cannula</keyword>
  <keyword>Dyspnoea</keyword>
  <keyword>Opioids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Death</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/NCT02253667
org study id: PalliativeHFONC
nct id: NCT02253667
lead sponsor: 
has dmc: No
The prevalence of severe dyspnoea among terminally ill patients has been reported as 70% and
      90% for lung cancer and chronic obstructive pulmonary disease (COPD) patients, respectively.

      Current management to dyspnoea includes opioids, psychotropic drugs, inhaled frusemide,
      Heliox 28 and oxygen.

      Conventional oxygen supplementation is often used in these patients, but it may be
      inadequate, especially if they require high flows (from 30L/min to 120L/min in acute
      respiratory failure).

      High-flow oxygen nasal cannula (HFONC) is a new technological device in high-flow oxygen
      system that consists of an air-oxygen blender (allowing from 21% to 100% FiO2) which
      generates the gas flow rate up to 55 L/min and a heated humidification system. This
      technology may have an important role in reducing respiratory distress in do-not-intubate
      patients.

      Some HFONC's beneficial effects are the washout of the nasopharyngeal dead space reducing
      rebreathing of CO2 and improvement oxygenation through greater alveolar oxygen concentration;
      a better matching between patient's inspiratory demand and oxygen flow; generation of a
      certain level of positive pressure (PEEP) contributing to the pulmonary distending pressure
      and recruitment; improvement of lung and airway mucociliary clearance due to the heated and
      humidified oxygen; and patient's comfort because of the nasal interface allowing feeding and
      speech.

      The investigators hypothesize that patients supported with HFONC need less opioids to
      decrease dyspnoea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Dyspnoea
time frame: 2 days
description: We aim to reduce dyspnoea more effective, using Borg Scale, with HFONC compared to conventional oxygen mask.
measure: Opioids
time frame: 2 days
description: By randomizing the two groups we will be able to compare the total use of opioids.
measure: Physiologic variables
time frame: 2 days
description: The comparison in respiratory rate, heart rate, mean arterial pressure and oxygen saturation between the two groups.
measure: Patient comfort
time frame: 2 days
description: Detect if there is a difference in patient comfort using HFONC or conventional oxygen mask.
measure: Mortality
time frame: 6 months
description: Overall mortality in hospital and at 3 months and 6 months after discharge.
arm group label: HFONC
arm group type: Experimental
description: Patient will use HFONC with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.
arm group label: Conventional oxygen
arm group type: Other
description: Patient will use venturi or reservoir mask with FiO2 enough to achieve SpO2>90%. If needed, morphine is titrated to reduce a patient's dyspnoea score by at least one point on the Borg scale and to achieve at least level 5 or less. Initial dose: 10 mg, repeated every 4h until the desired reduction in dyspnoea is obtained. In the case of refractory dyspnoea, the dose is increased by 50%.
intervention type: Device
intervention name: HFONC
arm group label: HFONC
other name: Optiflow (Fisher&Paykel ™)
intervention type: Device
intervention name: Conventional oxygen therapy
arm group label: Conventional oxygen
other name: Venturi mask
other name: Reservoir mask
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Miguel R Gonçalves, PhD
role: Principal Investigator
affiliation: Pulmonology Department, University Hospital São João
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Hospital Sao Joao
investigator full name: Miguel R. Goncalves
investigator title: Clinical Professor, PH.D
mesh term: Lung Diseases
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Death