<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/NCT03243539</url>
  </required_header>
  <id_info>
    <org_study_id>1050582</org_study_id>
    <nct_id>NCT03243539</nct_id>
  </id_info>
  <brief_title>Implementation of Neuro Lung Protective Ventilation</brief_title>
  <acronym>NEUROVENT</acronym>
  <official_title>Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colin Grissom</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intermountain Health Care, Inc.</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>
      Patients who experience lung injury are often placed on a ventilator to help them heal;&#xD;
      however, if the ventilator volume settings are too high, it can cause additional lung injury.&#xD;
      It is proven that using lower ventilator volume settings improves outcomes. In patients with&#xD;
      acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide&#xD;
      in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes&#xD;
      and higher breathing rates are sometimes required to maintain a normal partial pressure of&#xD;
      carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent&#xD;
      additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both&#xD;
      important for patients with acute brain injury. The investigators have designed a&#xD;
      computerized ventilator protocol in iCentra that matches the current standard of care for&#xD;
      mechanical ventilation of patients with acute brain injury by targeting a normal partial&#xD;
      pressure of carbon dioxide with the lowest ventilator volume required.&#xD;
&#xD;
      This is a quality improvement study with the purpose of observing and measuring the effects&#xD;
      of implementation of a standard of care mechanical ventilation protocol for patients with&#xD;
      acute brain injury in the iCentra electronic medical record system at Intermountain Medical&#xD;
      Center. We hypothesize that implementation of a standardized neuro lung protective&#xD;
      ventilation protocol will be feasible, will achieve a target normal partial pressure of&#xD;
      carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight,&#xD;
      and will improve outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume &lt;= 6.5 ml/kg PBW</measure>
    <time_frame>Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of time with a target PaCO2 of 35 to 45 mm Hg</measure>
    <time_frame>Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of protocol deviations for all subjects (protocol compliance)</measure>
    <time_frame>Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days</time_frame>
    <description>Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Discharge Disposition</measure>
    <time_frame>Day of hospital discharge, an average of 10 days after admission</time_frame>
    <description>Routine, skilled nursing facility, home health, other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital, 28-Day, and 90-Day Mortality</measure>
    <time_frame>Hospital admission through 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free days to day 28</measure>
    <time_frame>Initiation of mechanical ventilation to day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First ICU Activity</measure>
    <time_frame>Day of admission to day of first ICU activity, an average of 0.2 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital, ICU Length of Stay</measure>
    <time_frame>Day of admission to day of discharge, an average of 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Utilization</measure>
    <time_frame>Day of admission to day of discharge, an average of 10 days</time_frame>
    <description>Number of procedures/surgeries while in the hospital and number of days of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Day of admission until up to 1 year after day of discharge</time_frame>
    <description>May include SF-36 or similar measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of Care</measure>
    <time_frame>Day of admission to day of discharge, an average of 10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">728</enrollment>
  <condition>Acute Brain Injury</condition>
  <condition>Traumatic Brain Injury</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Stroke</condition>
  <condition>Cerebral Edema</condition>
  <condition>Anoxic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Lung Protective Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung Protective Ventilation</intervention_name>
    <description>Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)</description>
    <arm_group_label>Lung Protective Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial&#xD;
             hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.&#xD;
&#xD;
          2. Initiation of mechanical ventilation in the emergency department or intensive care&#xD;
             unit at an Intermountain Healthcare hospital&#xD;
&#xD;
          3. Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Transition to comfort care in the emergency department or on the same day of admission&#xD;
             to the ICU&#xD;
&#xD;
          2. Death on the same day of admission to the emergency department or ICU&#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>Colin K Grissom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Colin Grissom</investigator_full_name>
    <investigator_title>Co-Medical Director Shock Trauma ICU</investigator_title>
  </responsible_party>
  <keyword>lung protective ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Brain Edema</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.</ipd_description>
  </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>July 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03243539/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/NCT03243539
org study id: 1050582
nct id: NCT03243539
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who experience lung injury are often placed on a ventilator to help them heal;
      however, if the ventilator volume settings are too high, it can cause additional lung injury.
      It is proven that using lower ventilator volume settings improves outcomes. In patients with
      acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide
      in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes
      and higher breathing rates are sometimes required to maintain a normal partial pressure of
      carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent
      additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both
      important for patients with acute brain injury. The investigators have designed a
      computerized ventilator protocol in iCentra that matches the current standard of care for
      mechanical ventilation of patients with acute brain injury by targeting a normal partial
      pressure of carbon dioxide with the lowest ventilator volume required.

      This is a quality improvement study with the purpose of observing and measuring the effects
      of implementation of a standard of care mechanical ventilation protocol for patients with
      acute brain injury in the iCentra electronic medical record system at Intermountain Medical
      Center. We hypothesize that implementation of a standardized neuro lung protective
      ventilation protocol will be feasible, will achieve a target normal partial pressure of
      carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight,
      and will improve outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW
time frame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
measure: Proportion of time with a target PaCO2 of 35 to 45 mm Hg
time frame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
measure: Average number of protocol deviations for all subjects (protocol compliance)
time frame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
description: Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject
measure: Hospital Discharge Disposition
time frame: Day of hospital discharge, an average of 10 days after admission
description: Routine, skilled nursing facility, home health, other
measure: Hospital, 28-Day, and 90-Day Mortality
time frame: Hospital admission through 90 days
measure: Ventilator-free days to day 28
time frame: Initiation of mechanical ventilation to day 28
measure: Time to First ICU Activity
time frame: Day of admission to day of first ICU activity, an average of 0.2 days
measure: Hospital, ICU Length of Stay
time frame: Day of admission to day of discharge, an average of 10 days
measure: Health Care Utilization
time frame: Day of admission to day of discharge, an average of 10 days
description: Number of procedures/surgeries while in the hospital and number of days of hospitalization
measure: Quality of Life
time frame: Day of admission until up to 1 year after day of discharge
description: May include SF-36 or similar measures
measure: Costs of Care
time frame: Day of admission to day of discharge, an average of 10 days
arm group label: Lung Protective Ventilation
arm group type: Experimental
description: Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed.
intervention type: Procedure
intervention name: Lung Protective Ventilation
description: Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)
arm group label: Lung Protective Ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colin K Grissom, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Colin Grissom
investigator title: Co-Medical Director Shock Trauma ICU
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Cerebral Hemorrhage
mesh term: Brain Edema
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: The intent of the investigators is to publish their experience with implementation of this protocol in the peer reviewed medical literature.
provided document: 