<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/NCT03278769</url>
  </required_header>
  <id_info>
    <org_study_id>Brain-Vent</org_study_id>
    <nct_id>NCT03278769</nct_id>
  </id_info>
  <brief_title>Ventilator Settings on Patients With Acute Brain Injury</brief_title>
  <official_title>Relation Between Lung Protective Mechanical Ventilation, Intracranial Pressure, Autoregulation and Brain Oxygenation in Neurointensive Care Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital de la Croix-Rousse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of North Norway</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>
      The present study is an explorative analysis of the relationship between cerebral blood&#xD;
      perfusion and oxygenation and lung mechanical variables at different ventilator settings. It&#xD;
      is a safety study excluding patients with severe lung injury or brain edema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary goal is to carry out baseline measurements to enable conclusions concerning the&#xD;
      safety of lung protective ventilator settings before extending the study to patients with&#xD;
      more severe brain and/or lung injury in the future.&#xD;
&#xD;
      The primary objective is to investigate if lung protective ventilator settings (higher&#xD;
      Positive end-expiratory pressure and lower tidal volume) as compared with conventional&#xD;
      settings.&#xD;
&#xD;
        1. increase intracranial pressure&#xD;
&#xD;
        2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index,&#xD;
           ie pressure reactivity index will turn positive, which means that it will change the&#xD;
           state from intact to impaired autoregulation.&#xD;
&#xD;
      The secondary objective is an exploratory analysis of the relationship between ventilator&#xD;
      settings and other well defined respiratory, cerebral, and cardiovascular variables,&#xD;
      including transpulmonary pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intracranial pressure</measure>
    <time_frame>120 minutes</time_frame>
    <description>intracranial pressure increase with lung protective setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pressure reactivity index</measure>
    <time_frame>120 minutes</time_frame>
    <description>Diminished pressure reactivity index</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Acute Brain Injury</condition>
  <condition>Ventilator-Induced Lung Injury</condition>
  <condition>Cerebrovascular Circulation</condition>
  <arm_group>
    <arm_group_label>Ventilator setting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Positive end-expiratory pressure , Tidal volume</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung protective ventilator settings</intervention_name>
    <description>Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight</description>
    <arm_group_label>Ventilator setting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Any tracheally intubated or tracheotomized adult patient with ABI with GCS&lt; 9 on&#xD;
             controlled ventilation requiring continuous ICP measurement.&#xD;
&#xD;
          -  Proxy informed consent from relatives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • ICP &gt; 22 mmHg before treatment of high ICP&#xD;
&#xD;
          -  Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen&#xD;
             fraction (PaO2/FiO2) ratio &lt; 40 kPa and Xray pathology&#xD;
&#xD;
          -  History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in&#xD;
             the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 35.&#xD;
&#xD;
          -  Known right or biventricular cardiac failure with cardiac index &lt; 2,5 L/min/m2 or&#xD;
             ejection fracture &lt; 40 %.&#xD;
&#xD;
          -  Refractory hypovolemia as diagnosed with pulse pressure variation &gt; 12 % with tidal&#xD;
             volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg&#xD;
             rise test with &gt; 10 % increase in stroke volume measured by VTI echocardiography or&#xD;
             PICCO.&#xD;
&#xD;
          -  Medulla lesion that affect the autonomic nervous system.&#xD;
&#xD;
          -  Patients who has undergone decompressive craniectomy.&#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>Shirin K Frisvold</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital North Norway</name>
      <address>
        <city>Tromsø</city>
        <state>Troms</state>
        <zip>9010</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.</citation>
    <PMID>19388307</PMID>
  </reference>
  <reference>
    <citation>Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.</citation>
    <PMID>26855895</PMID>
  </reference>
  <reference>
    <citation>Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.</citation>
    <PMID>27334266</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of North Norway</investigator_affiliation>
    <investigator_full_name>Shirin Kordasti Frisvold</investigator_full_name>
    <investigator_title>Principal investigator, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03278769/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03278769
org study id: Brain-Vent
nct id: NCT03278769
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study is an explorative analysis of the relationship between cerebral blood
      perfusion and oxygenation and lung mechanical variables at different ventilator settings. It
      is a safety study excluding patients with severe lung injury or brain edema.
The primary goal is to carry out baseline measurements to enable conclusions concerning the
      safety of lung protective ventilator settings before extending the study to patients with
      more severe brain and/or lung injury in the future.

      The primary objective is to investigate if lung protective ventilator settings (higher
      Positive end-expiratory pressure and lower tidal volume) as compared with conventional
      settings.

        1. increase intracranial pressure

        2. diminish cerebral vasoreactive autoregulation as assessed by pressure reactivity index,
           ie pressure reactivity index will turn positive, which means that it will change the
           state from intact to impaired autoregulation.

      The secondary objective is an exploratory analysis of the relationship between ventilator
      settings and other well defined respiratory, cerebral, and cardiovascular variables,
      including transpulmonary pressure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Intracranial pressure
time frame: 120 minutes
description: intracranial pressure increase with lung protective setting
measure: pressure reactivity index
time frame: 120 minutes
description: Diminished pressure reactivity index
arm group label: Ventilator setting
arm group type: Experimental
description: Positive end-expiratory pressure , Tidal volume
intervention type: Procedure
intervention name: Lung protective ventilator settings
description: Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
arm group label: Ventilator setting
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shirin K Frisvold
role: Principal Investigator
affiliation: University Hospital of North Norway
facility: 
country: Norway
citation: Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.
PMID: 19388307
citation: Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.
PMID: 26855895
citation: Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PMID: 27334266
responsible party type: Principal Investigator
investigator affiliation: University Hospital of North Norway
investigator full name: Shirin Kordasti Frisvold
investigator title: Principal investigator, PhD
mesh term: Lung Injury
mesh term: Ventilator-Induced Lung Injury
mesh term: Brain Injuries
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 