<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/NCT03763461</url>
  </required_header>
  <id_info>
    <org_study_id>112229</org_study_id>
    <nct_id>NCT03763461</nct_id>
  </id_info>
  <brief_title>HFNC During Awake Craniotomy - Impact on Patient Comfort</brief_title>
  <official_title>Comparison of Pre-warmed, Humidified High Flow Nasal Cannula (HFNC) Oxygen Therapy and Traditional Oxygen Therapy on Patient Comfort and Gas Exchange During Awake Craniotomy - A Single Centre, Prospective, Randomized, Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</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>
      Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed&#xD;
      oxygen/air mix flow through a face mask for a prolonged duration. This causes increased&#xD;
      discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high&#xD;
      flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air&#xD;
      exchange, improves surgical conditions and prevents atelectasis of the lung, compared to&#xD;
      traditional oxygen administration using a face mask in patients undergoing awake brain&#xD;
      surgery.&#xD;
&#xD;
      Results of this trial will be used to initiate a more extensive, multicenter trial to further&#xD;
      characterize the potential impact of HFNC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed&#xD;
      oxygen/air mix flow through a face mask for a prolonged duration. This causes increased&#xD;
      discomfort, inadequate breathing with the risk for hypoxia perioperatively.&#xD;
&#xD;
      Hypothesis: Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient&#xD;
      comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the&#xD;
      lung, compared to traditional oxygen administration using a face mask in patients undergoing&#xD;
      awake brain surgery.&#xD;
&#xD;
      Methods: After obtaining ethics approval and written informed patient consent, 20 patients&#xD;
      undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or&#xD;
      standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with&#xD;
      drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be&#xD;
      performed during and after the procedure. Lung ultrasound will be performed in the recovery&#xD;
      room to determine the presence of atelectasis.&#xD;
&#xD;
      Expected results and Significance: We expect that HFNC improves patient comfort as well as&#xD;
      breathing / arterial oxygen content in long-duration awake brain surgery. This could result&#xD;
      in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen&#xD;
      therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide -&#xD;
      which could lead to better surgical conditions due to softer brain tissue and therefore&#xD;
      shorter time for the surgical procedure. Potential positive results of this trial will be&#xD;
      used to initiate a more extensive, multicenter trial to further characterize the potential&#xD;
      impact of HFNC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient comfort using VAS (1-10)</measure>
    <time_frame>During surgical procedure, an average of 6 hours</time_frame>
    <description>Patient comfort during awake craniotomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gas exchange (blood gas analysis)</measure>
    <time_frame>During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pulmonary atelectasis using Ultrasound evaluation</measure>
    <time_frame>Up to 15 minutes before PACU discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of oxygen desaturation (number of events with SaO2 &lt; 90%)</measure>
    <time_frame>During surgical procedure, an average of 6 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Pulmonary Atelectasis</condition>
  <condition>Patient Comfort</condition>
  <arm_group>
    <arm_group_label>HFNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HFNC will be started at flow of 40 L/min and FiO2 of 40%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxygen Mask</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HFNC</intervention_name>
    <description>High flow nasal humidified oxygen HFNC is an air-oxygen blender, which provides high flow (up to 60 L/min) of warmed (36°C) and humidified gas through nasal cannula, allowing tighter control of FiO2 from 0.2 to 1.0.</description>
    <arm_group_label>HFNC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxygen Mask</intervention_name>
    <description>Application of oxygen during conscious sedation</description>
    <arm_group_label>Oxygen Mask</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergoing elective awake craniotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA &gt; 4&#xD;
&#xD;
          -  pregnant females&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 40&#xD;
&#xD;
          -  elective postoperative mechanical ventilation/conversion to general anesthesia&#xD;
&#xD;
          -  denial of consent&#xD;
&#xD;
          -  obstructive sleep apnea requiring CPAP&#xD;
&#xD;
          -  severe COPD requiring home oxygen therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LHSC</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Awake Craniotomy</keyword>
  <keyword>HFNC</keyword>
  <keyword>Oxygen Therapy</keyword>
  <keyword>Atelectasis</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Patient Comfort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</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/NCT03763461
org study id: 112229
nct id: NCT03763461
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed
      oxygen/air mix flow through a face mask for a prolonged duration. This causes increased
      discomfort, inadequate breathing with the risk for hypoxia perioperatively. Humidified high
      flow nasal cannula (HFNC) oxygen therapy potentially improves patient comfort, oxygen/air
      exchange, improves surgical conditions and prevents atelectasis of the lung, compared to
      traditional oxygen administration using a face mask in patients undergoing awake brain
      surgery.

      Results of this trial will be used to initiate a more extensive, multicenter trial to further
      characterize the potential impact of HFNC.
Background: Patients undergoing awake brain surgery are exposed to non-humidified, non-warmed
      oxygen/air mix flow through a face mask for a prolonged duration. This causes increased
      discomfort, inadequate breathing with the risk for hypoxia perioperatively.

      Hypothesis: Humidified high flow nasal cannula (HFNC) oxygen therapy improves patient
      comfort, oxygen/air exchange, improves surgical conditions and prevents atelectasis of the
      lung, compared to traditional oxygen administration using a face mask in patients undergoing
      awake brain surgery.

      Methods: After obtaining ethics approval and written informed patient consent, 20 patients
      undergoing scheduled awake brain surgery will be randomized to either HFNC therapy or
      standard face mask. Evaluation of patient satisfaction, pain / dry upper airway along with
      drawing of arterial blood gases to measure oxygen/carbon dioxide content of the blood will be
      performed during and after the procedure. Lung ultrasound will be performed in the recovery
      room to determine the presence of atelectasis.

      Expected results and Significance: We expect that HFNC improves patient comfort as well as
      breathing / arterial oxygen content in long-duration awake brain surgery. This could result
      in higher patient satisfaction, shorter times in PACU, a shorter requirement for oxygen
      therapy, decreased risk for hypoxia during surgery and better elimination of carbon dioxide -
      which could lead to better surgical conditions due to softer brain tissue and therefore
      shorter time for the surgical procedure. Potential positive results of this trial will be
      used to initiate a more extensive, multicenter trial to further characterize the potential
      impact of HFNC.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient comfort using VAS (1-10)
time frame: During surgical procedure, an average of 6 hours
description: Patient comfort during awake craniotomy
measure: Gas exchange (blood gas analysis)
time frame: During surgical procedure (an average of 6 hours) and 15 minutes after PACU admission
measure: Post-operative pulmonary atelectasis using Ultrasound evaluation
time frame: Up to 15 minutes before PACU discharge
measure: Incidence of oxygen desaturation (number of events with SaO2 < 90%)
time frame: During surgical procedure, an average of 6 hours
arm group label: HFNC
arm group type: Experimental
description: HFNC will be started at flow of 40 L/min and FiO2 of 40%.
arm group label: Oxygen Mask
arm group type: Other
description: Standard non-humidified oxygen therapy via an oxygen mask at 6 l/min will be performed.
intervention type: Device
intervention name: HFNC
description: High flow nasal humidified oxygen HFNC is an air-oxygen blender, which provides high flow (up to 60 L/min) of warmed (36°C) and humidified gas through nasal cannula, allowing tighter control of FiO2 from 0.2 to 1.0.
arm group label: HFNC
intervention type: Device
intervention name: Oxygen Mask
description: Application of oxygen during conscious sedation
arm group label: Oxygen Mask
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Pulmonary Atelectasis
sharing ipd: No