xml: <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/NCT05991843</url>
    </required_header>
    <id_info>
      <org_study_id>NL84438.091.23</org_study_id>
      <nct_id>NCT05991843</nct_id>
    </id_info>
    <brief_title>Respiratory Rate Measured by Pressure Variation During HFNC</brief_title>
    <official_title>Is it Possible to Measure an Adequate Respiration Rate Using Pressure Variation During HFNC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rijnstate Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rijnstate Hospital</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Monitoring the respiratory rate is important during procedural sedation. Several methods of&#xD;
        measuring the respiratory rate are available, but most are unreliable and the most reliable&#xD;
        method (capnography) is not available during the use of High Flow Nasal Cannula (HFNC)&#xD;
        oxygen. We hypothesize that measuring the pressure variation in the HFNC-circuit is a&#xD;
        reliable method of measuring the respiratory rate.&#xD;
  &#xD;
        An experimental study, using healthy volunteers that will breath in three guided respiratory&#xD;
        rates, compares the measurements of respiratory rate by the pressure variation in the HFNC&#xD;
        circuit with measurements of respiratory rate by an ECG-derived method and a manual count by&#xD;
        an physician.&#xD;
  &#xD;
        A secondary outcome will be the ability to measure the size of pressure difference, in order&#xD;
        to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The healthy volunteers will be administered HFNC-oxygen and will be instructed to breath&#xD;
        normally, rapidly and slowly for 30 seconds. This will be done at two HFNC flow rates (35&#xD;
        L/min and 70 L/min) and with an open and a closed mouth. During these 30 seconds the&#xD;
        respiratory rate will be measured by pressure variation in the HFNC circuit, ECG-derived&#xD;
        impedance difference and a manual count by a physician.&#xD;
  &#xD;
        This will lead to 12 conditions, depending on HFNC flow (35 and 70 L/min), open or closed&#xD;
        mouth and respiratory rate (normally, rapidly, slowly). The measurements of the respiratory&#xD;
        rates wil be compared per HFNC flow and per open or closed mouth.&#xD;
  &#xD;
        A secondary outcome will be the ability to measure the size of pressure difference, in order&#xD;
        to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Actual">August 23, 2023</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Respiratory rate by pressure variation</measure>
      <time_frame>30 seconds</time_frame>
      <description>Respiratory rate as measured by the pressure variation in the HFNC circuit.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory rate by manual count</measure>
      <time_frame>30 seconds</time_frame>
      <description>Respiratory rate as measured by a physician</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Respiratory rate by ECG-derived measurement</measure>
      <time_frame>30 seconds.</time_frame>
      <description>Respiratory rate as measured by the ECG-derived impedance difference</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pressure difference during breathing</measure>
      <time_frame>30 seconds.</time_frame>
      <description>The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Respiratory Rate</condition>
    <arm_group>
      <arm_group_label>Study cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by &quot;normal&quot;, &quot;slowly&quot; and &quot;rapid&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Instructions of breathing</intervention_name>
      <description>Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.</description>
      <arm_group_label>Study cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  healthy volunteers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  known neurodegenerative diseases&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Children (age &lt;18)&#xD;
  &#xD;
            -  Upper airway obstruction&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark V Koning, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rijnstate Hospital</name>
        <address>
          <city>Arnhem</city>
          <zip>6815 AD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rijnstate Hospital</investigator_affiliation>
      <investigator_full_name>Mark Koning</investigator_full_name>
      <investigator_title>Anesthesiologist-intensivist, principal investigator</investigator_title>
    </responsible_party>
    <keyword>High Flow Nasal Cannula</keyword>
    <keyword>Thrive</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Available upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Within 2 years</ipd_time_frame>
      <ipd_access_criteria>Available upon reasonable request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991843
  org study id: NL84438.091.23
  nct id: NCT05991843
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Monitoring the respiratory rate is important during procedural sedation. Several methods of
        measuring the respiratory rate are available, but most are unreliable and the most reliable
        method (capnography) is not available during the use of High Flow Nasal Cannula (HFNC)
        oxygen. We hypothesize that measuring the pressure variation in the HFNC-circuit is a
        reliable method of measuring the respiratory rate.
  
        An experimental study, using healthy volunteers that will breath in three guided respiratory
        rates, compares the measurements of respiratory rate by the pressure variation in the HFNC
        circuit with measurements of respiratory rate by an ECG-derived method and a manual count by
        an physician.
  
        A secondary outcome will be the ability to measure the size of pressure difference, in order
        to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.
  The healthy volunteers will be administered HFNC-oxygen and will be instructed to breath
        normally, rapidly and slowly for 30 seconds. This will be done at two HFNC flow rates (35
        L/min and 70 L/min) and with an open and a closed mouth. During these 30 seconds the
        respiratory rate will be measured by pressure variation in the HFNC circuit, ECG-derived
        impedance difference and a manual count by a physician.
  
        This will lead to 12 conditions, depending on HFNC flow (35 and 70 L/min), open or closed
        mouth and respiratory rate (normally, rapidly, slowly). The measurements of the respiratory
        rates wil be compared per HFNC flow and per open or closed mouth.
  
        A secondary outcome will be the ability to measure the size of pressure difference, in order
        to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Respiratory rate by pressure variation
  time frame: 30 seconds
  description: Respiratory rate as measured by the pressure variation in the HFNC circuit.
  measure: Respiratory rate by manual count
  time frame: 30 seconds
  description: Respiratory rate as measured by a physician
  measure: Respiratory rate by ECG-derived measurement
  time frame: 30 seconds.
  description: Respiratory rate as measured by the ECG-derived impedance difference
  measure: Pressure difference during breathing
  time frame: 30 seconds.
  description: The pressure difference measured in the HFNC-circuit between inspiration and expiration in cmH2O as the mean value over the 30 seconds.
  arm group label: Study cohort
  arm group type: Experimental
  description: The cohort of healthy volunteers, who will breath at three different respiratory rates, as guided by "normal", "slowly" and "rapid".
  intervention type: Behavioral
  intervention name: Instructions of breathing
  description: Breathing normally, slowly and rapidly for 30 seconds with an open and a closed mouth.
  arm group label: Study cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mark V Koning, MD, PhD
  role: Principal Investigator
  affiliation: Dept. of Anesthesiology and Critical Care, Rijnstate Hospital, Arnhem
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Rijnstate Hospital
  investigator full name: Mark Koning
  investigator title: Anesthesiologist-intensivist, principal investigator
  sharing ipd: Yes
  ipd description: Available upon reasonable request.
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Within 2 years
  ipd access criteria: Available upon reasonable request.