<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/NCT03797859</url>
  </required_header>
  <id_info>
    <org_study_id>H-18017844</org_study_id>
    <nct_id>NCT03797859</nct_id>
  </id_info>
  <brief_title>THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.</brief_title>
  <official_title>Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of&#xD;
      high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative&#xD;
      ventilation modality for an anesthetized patient without spontaneous respiration. This method&#xD;
      requires only basic airway management manoeuvres to keep the airway open and provides both&#xD;
      stable longterm oxygenation as well as apneic ventialtion.&#xD;
&#xD;
      We plan to evaluate this methods physiological performance under standardized conditions of&#xD;
      airway management by frequent, repeated arterial blood gas analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      THRIVE is previously shown feasible as sole mode of ventilation in selected patients during&#xD;
      general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where&#xD;
      direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation&#xD;
      and a degree of ventilation was observed. However, a slowly developed respiratory acidosis&#xD;
      was also observed over time.&#xD;
&#xD;
      Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth&#xD;
      breathing enhance the effects of the high flows of oxygen levels applied by increasing the&#xD;
      airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear&#xD;
      whether the efficiency of THRIVE depends on the particular circumstances of airway&#xD;
      management. Physiologic characterization of THRIVE performance under standardized conditions&#xD;
      of airway management and under close monitoring by systematic analysis of blood gas dynamics&#xD;
      over time during general anesthesia is needed.&#xD;
&#xD;
      We plan to study the blood gas dynamics during THRIVE apnea ventilation during general&#xD;
      anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients&#xD;
      will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics&#xD;
      and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under&#xD;
      7.15 and/or PaCO2-rise &gt; 12 kPa will lead to cessation of THRIVE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory acidosis</measure>
    <time_frame>Max. 60 minutes</time_frame>
    <description>Development of respiratory acidosis (pH &lt; 7.15 or paCO2 &gt; 12) over time on study</description>
  </primary_outcome>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Apnea</condition>
  <condition>Ventilation Therapy; Complications</condition>
  <condition>Respiratory Acidosis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Apneic ventilation</intervention_name>
    <description>Ventilation by THRIVE</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is&#xD;
        not mandatory.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult (age over 18 years)&#xD;
&#xD;
          2. Elective surgery where intubation is not mandatory&#xD;
&#xD;
          3. The patient can understand the information about the study and give their informed&#xD;
             written consent of participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ASA (American Society of Anaesthesiologists class) &gt; 3&#xD;
&#xD;
          2. NYHA (New York Heart Association class) &gt; 2&#xD;
&#xD;
          3. BMI &gt; 30 kg/m2&#xD;
&#xD;
          4. Symptomatic respiratory disease&#xD;
&#xD;
          5. Symptomatic cardiac disease&#xD;
&#xD;
          6. Evidence of arteriosclerotic disease&#xD;
&#xD;
          7. Neuromuscular disease&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score &gt; 4)&#xD;
&#xD;
         10. Known or suspected nasal congestion/stenosis or catharalia&#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>Michael S Kristensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior consultant, Rigshospitalet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Hoevdstaden</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 19, 2019</last_update_submitted>
  <last_update_submitted_qc>January 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Michael Seltz Kristensen</investigator_full_name>
    <investigator_title>SENIOR CONSULTANT</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acidosis, Respiratory</mesh_term>
    <mesh_term>Acidosis</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/NCT03797859
org study id: H-18017844
nct id: NCT03797859
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of
      high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative
      ventilation modality for an anesthetized patient without spontaneous respiration. This method
      requires only basic airway management manoeuvres to keep the airway open and provides both
      stable longterm oxygenation as well as apneic ventialtion.

      We plan to evaluate this methods physiological performance under standardized conditions of
      airway management by frequent, repeated arterial blood gas analyses.
THRIVE is previously shown feasible as sole mode of ventilation in selected patients during
      general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where
      direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation
      and a degree of ventilation was observed. However, a slowly developed respiratory acidosis
      was also observed over time.

      Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth
      breathing enhance the effects of the high flows of oxygen levels applied by increasing the
      airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear
      whether the efficiency of THRIVE depends on the particular circumstances of airway
      management. Physiologic characterization of THRIVE performance under standardized conditions
      of airway management and under close monitoring by systematic analysis of blood gas dynamics
      over time during general anesthesia is needed.

      We plan to study the blood gas dynamics during THRIVE apnea ventilation during general
      anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients
      will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics
      and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under
      7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE.
observational model: Case-Only
time perspective: Prospective
measure: Respiratory acidosis
time frame: Max. 60 minutes
description: Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study
intervention type: Procedure
intervention name: Apneic ventilation
description: Ventilation by THRIVE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S Kristensen, MD
role: Principal Investigator
affiliation: Senior consultant, Rigshospitalet
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Michael Seltz Kristensen
investigator title: SENIOR CONSULTANT
mesh term: Acidosis, Respiratory
mesh term: Acidosis
sharing ipd: No