<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/NCT03822026</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH 2012-0542 (1)</org_study_id>
    <nct_id>NCT03822026</nct_id>
  </id_info>
  <brief_title>Hyperventilation in Patients With Traumatic Brain Injury</brief_title>
  <official_title>Effects of Moderate Hyperventilation on Cerebral Hemodynamics, Oxygenation and Metabolism in Patients With Severe Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Elevated intracranial pressure is a dangerous and potentially fatal complication after&#xD;
      traumatic brain injury. Hyperventilation is a medical intervention to reduce elevated&#xD;
      intracranial pressure by inducing cerebral vasoconstriction, which might be associated to&#xD;
      cerebral ischemia and hypoxia.&#xD;
&#xD;
      The main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the&#xD;
      intracranial pressure without inducing cerebral ischemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with severe traumatic brain injury (TBI), and with intracranial&#xD;
      pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes&#xD;
      hyperventilation-tests are performed in the acute phase after trauma. Data are collected and&#xD;
      TCCD measurements are performed at baseline, at the beginning of moderate hyperventilation,&#xD;
      after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline.&#xD;
&#xD;
      The present study aims to quantify potential adverse effects of moderate short-term&#xD;
      hyperventilation during the acute phase of the severe TBI on cerebral hemodynamics,&#xD;
      oxygenation, and metabolism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2014</start_date>
  <completion_date type="Actual">May 2, 2017</completion_date>
  <primary_completion_date type="Actual">May 2, 2017</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>
    <intervention_model_description>several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intracranial pressure</measure>
    <time_frame>10, 20, 50, 60 minutes after begin of the hyperventilation test</time_frame>
    <description>Change of intracranial pressure during moderate hyperventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cerebral flow velocity in the middle cerebral artery</measure>
    <time_frame>20, 50, 60 minutes after begin of the hyperventilation test</time_frame>
    <description>Change of cerebral flow velocity during moderate hyperventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>brain tissue oxygenation (PbrO2)</measure>
    <time_frame>10, 20, 50, 60 minutes after begin of the hyperventilation test</time_frame>
    <description>no changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral Lactate/ Pyruvate ratio</measure>
    <time_frame>1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test</time_frame>
    <description>no changes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Head Injury Trauma</condition>
  <condition>Hyperventilation</condition>
  <arm_group>
    <arm_group_label>patients with severe TBI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with severe TBI enrolled in the study undergo an hyperventilation test, in which the alveolar ventilation is increased by a stepwise increase in tidal volumes and respiratory rate until a reduction of etCO2 of 0.7 kPa is achieved.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperventilation test</intervention_name>
    <description>Increase of the alveolar ventilation by a stepwise increase in tidal volumes and respiratory rate until a reduction of end-tidal CO2 of 0.7 kPa is achieved</description>
    <arm_group_label>patients with severe TBI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nonpenetrating traumatic brain injury&#xD;
&#xD;
          -  Glasgow coma scale &lt;9 at presentation&#xD;
&#xD;
          -  Intracranial pressure monitoring&#xD;
&#xD;
          -  brain tissue oxygen tension monitoring and/or microdialysis monitoring&#xD;
&#xD;
          -  invasive mechanical ventilation with FIO2 &lt;60% and PEEP &lt;15 mbar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  decompressive craniectomy&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  pre-existing neurological disease&#xD;
&#xD;
          -  previous traumatic brain injury&#xD;
&#xD;
          -  acute cardiovascular disease&#xD;
&#xD;
          -  severe respiratory failure&#xD;
&#xD;
          -  acute on chronic liver disease&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  failure to obtain satisfactory bilateral TCCD signals&#xD;
&#xD;
          -  persisting hypovolemia or hemodynamic instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Steiger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intracranial pressure</keyword>
  <keyword>cerebral metabolism</keyword>
  <keyword>cerebral oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperventilation</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03822026
org study id: KEK-ZH 2012-0542 (1)
nct id: NCT03822026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Elevated intracranial pressure is a dangerous and potentially fatal complication after
      traumatic brain injury. Hyperventilation is a medical intervention to reduce elevated
      intracranial pressure by inducing cerebral vasoconstriction, which might be associated to
      cerebral ischemia and hypoxia.

      The main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the
      intracranial pressure without inducing cerebral ischemia.
In patients with severe traumatic brain injury (TBI), and with intracranial
      pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes
      hyperventilation-tests are performed in the acute phase after trauma. Data are collected and
      TCCD measurements are performed at baseline, at the beginning of moderate hyperventilation,
      after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline.

      The present study aims to quantify potential adverse effects of moderate short-term
      hyperventilation during the acute phase of the severe TBI on cerebral hemodynamics,
      oxygenation, and metabolism.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: several parameters are collected at different time points: at baseline conditions, during moderate hyperventilation, and after return to baseline
primary purpose: Treatment
masking: None (Open Label)
measure: intracranial pressure
time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
description: Change of intracranial pressure during moderate hyperventilation
measure: cerebral flow velocity in the middle cerebral artery
time frame: 20, 50, 60 minutes after begin of the hyperventilation test
description: Change of cerebral flow velocity during moderate hyperventilation
measure: brain tissue oxygenation (PbrO2)
time frame: 10, 20, 50, 60 minutes after begin of the hyperventilation test
description: no changes
measure: cerebral Lactate/ Pyruvate ratio
time frame: 1 hour before initiation of the hyperventilation test, and 1 and 2 hours after begin of the hyperventilation test
description: no changes
arm group label: patients with severe TBI
arm group type: Other
description: Patients with severe TBI enrolled in the study undergo an hyperventilation test, in which the alveolar ventilation is increased by a stepwise increase in tidal volumes and respiratory rate until a reduction of etCO2 of 0.7 kPa is achieved.
intervention type: Other
intervention name: Hyperventilation test
description: Increase of the alveolar ventilation by a stepwise increase in tidal volumes and respiratory rate until a reduction of end-tidal CO2 of 0.7 kPa is achieved
arm group label: patients with severe TBI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Steiger, MD
role: Principal Investigator
affiliation: University of Zurich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hyperventilation
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Craniocerebral Trauma
mesh term: Wounds and Injuries