<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/NCT03289715</url>
  </required_header>
  <id_info>
    <org_study_id>ICBE-2-16558</org_study_id>
    <nct_id>NCT03289715</nct_id>
  </id_info>
  <brief_title>Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation</brief_title>
  <official_title>Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Electronics Nederland B.V. acting through Philips CTO organization</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Electronics Nederland B.V. acting through Philips CTO organization</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>
      Monocenter study to determine and evaluate the optimal amount of humidification doses&#xD;
      delivered by the On-Demand humidification system in neuromuscular patients requiring home&#xD;
      mechanical ventilation. The patient's perception will be monitored with subjective as well as&#xD;
      with objective measurements of the optimum comfortable on-demand humidification doses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>questionnaire based on Borg Scale and Visual Analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>heart rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>breathing rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>SpO2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>transcutaneous CO2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>optimum comfortable amount of on-demand humidification</measure>
    <time_frame>3 hours</time_frame>
    <description>number of mucus clearance events</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>on demand humidification</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>On Demand Humidification system Mark 2</intervention_name>
    <description>The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.</description>
    <arm_group_label>arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 of age; &lt; 85 years of age&#xD;
&#xD;
          2. Participants with a neuromuscular disorder who:&#xD;
&#xD;
               1. Require 24 hour mechanical ventilation in some form through tracheostomy, mask or&#xD;
                  mouth piece&#xD;
&#xD;
               2. Can be ambulatory for at least a few hours during the day while using a heat and&#xD;
                  moisture exchange device (HME) or no humidification&#xD;
&#xD;
               3. Can part of the day use a heated pass-over humidification system while on their&#xD;
                  ventilator (overnight, for example).&#xD;
&#xD;
          3. Able to provide feedback/articulate via some form of communication&#xD;
&#xD;
          4. Patients using a Trilogy ventilator&#xD;
&#xD;
          5. Invasively ventilated patients that are willing to use a HME device on their way to&#xD;
             participate in the study (from home to hospital).&#xD;
&#xD;
          6. Patients that are willing to participate and are able to consent and sign the informed&#xD;
             consent form. (Patients with the functional capacity for medical decision-making).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinically unstable, i.e.,&#xD;
&#xD;
               1. Acute respiratory failure&#xD;
&#xD;
               2. Participants with refractory hypotension (defined as systolic blood pressure less&#xD;
                  than 90 mm Hg despite inotropic agents)&#xD;
&#xD;
               3. Uncontrolled cardiac ischemia or arrhythmias&#xD;
&#xD;
               4. Any participant determined as inappropriate for the study by the Principal&#xD;
                  Investigator&#xD;
&#xD;
          2. Patients suffering from metastatic or terminal cancer&#xD;
&#xD;
          3. Patients lacking the functional capacity for medical decision-making.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</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>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03289715
org study id: ICBE-2-16558
nct id: NCT03289715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Monocenter study to determine and evaluate the optimal amount of humidification doses
      delivered by the On-Demand humidification system in neuromuscular patients requiring home
      mechanical ventilation. The patient's perception will be monitored with subjective as well as
      with objective measurements of the optimum comfortable on-demand humidification doses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: questionnaire based on Borg Scale and Visual Analog scale
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: heart rate
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: breathing rate
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: SpO2
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: transcutaneous CO2
measure: optimum comfortable amount of on-demand humidification
time frame: 3 hours
description: number of mucus clearance events
arm group label: arm 1
arm group type: Experimental
description: on demand humidification
intervention type: Device
intervention name: On Demand Humidification system Mark 2
description: The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.
arm group label: arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Neuromuscular Diseases
sharing ipd: No