xml: <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/NCT05969028</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00014110</org_study_id>
      <nct_id>NCT05969028</nct_id>
    </id_info>
    <brief_title>First Responder Airway &amp; Compression Rate Trial</brief_title>
    <acronym>FACT</acronym>
    <official_title>First Responder Airway &amp; Compression Rate Trial (FACT Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Washington</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The First responder Airway &amp; Compression rate Trial (FACT) Study will address basic life&#xD;
        support (BLS) treatments administered by Emergency Medical Services (EMS) first responders to&#xD;
        patients who suffer a sudden circulatory (pulseless) collapse, referred to as sudden&#xD;
        out-of-hospital cardiac arrest (SCA). The investigators propose a randomized controlled trial&#xD;
        among persons who suffer SCA to compare these two rescue breathing approaches (standard Bag&#xD;
        Valve Mask vs i-gel) along with evaluating a more precise chest compression rate within the&#xD;
        range of 100-120 compressions per minute during CPR. Importantly, each of these treatments&#xD;
        fall within established resuscitation guidelines and are already administered as part of&#xD;
        standard care in clinical practice. Thus this proposed trial will essentially be comparing&#xD;
        one standard-of-care treatment against another standard-of-care treatment.&#xD;
  &#xD;
        The study will address two primary aims:&#xD;
  &#xD;
        Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM&#xD;
        versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will&#xD;
        result in a higher rate of survival to hospital discharge than BVM.&#xD;
  &#xD;
        Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest&#xD;
        compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment&#xD;
        with 100 chest compressions per minute will result in a higher rate of survival to hospital&#xD;
        discharge than compression rates of 110 or 120 per minute.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The First responder Airway &amp; Compression rate Trial (FACT) Study will address basic life&#xD;
        support (BLS) treatments administered by EMS first responders to patients who suffer a sudden&#xD;
        circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac arrest (SCA).&#xD;
        The current standard of practice for first responder CPR includes chest compressions at a&#xD;
        rate of 100-120 compressions per minute combined with rescue breathing using either a bag&#xD;
        valve mask (BVM) or a type of oral airway called an i-gel. During rescue breathing with a&#xD;
        BVM, a mask is attached to a breathing bag and placed over the patient's face. The BVM&#xD;
        provides oxygen and clears carbon dioxide out of the lungs by blowing air through the&#xD;
        patient's mouth. Alternatively, the i-gel consists of a short tube which is inserted in the&#xD;
        back of the patient's throat. This tube blows oxygen more directly into the lungs, bypassing&#xD;
        the mouth itself. Each of these breathing methods is considered standard of care treatment by&#xD;
        EMS first responders. Standard of care means each method is commonly used to treat patients&#xD;
        in cardiac arrest and is performed regularly, depending upon the community in which the&#xD;
        cardiac arrest has occurred. The other component of CPR is chest compressions. The American&#xD;
        Heart Association has recommended a chest compression rate during CPR of between 100-120&#xD;
        compressions per minute, but has not specified an ideal exact compression rate within this&#xD;
        range. Scientific studies in both animals and clinical studies have shown that these&#xD;
        different standard-of-care approaches to ventilation and the compression rate can produce&#xD;
        different physiologic effects (such as the adequacy of rescue breathing and blood flow) that&#xD;
        could impact clinical outcome. The investigators propose a randomized controlled trial among&#xD;
        persons who suffer SCA to compare these two rescue breathing approaches along with evaluating&#xD;
        a more precise chest compression rate within the range of 100-120 compressions per minute&#xD;
        during CPR. Importantly, each of these treatments fall within established resuscitation&#xD;
        guidelines and are already administered as part of standard care in clinical practice. Thus&#xD;
        this proposed trial will essentially be comparing one standard-of-care treatment against&#xD;
        another standard-of-care treatment.&#xD;
  &#xD;
        The study will address two primary aims:&#xD;
  &#xD;
        Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM&#xD;
        versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will&#xD;
        result in a higher rate of survival to hospital discharge than BVM.&#xD;
  &#xD;
        Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest&#xD;
        compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment&#xD;
        with 100 chest compressions per minute will result in a higher rate of survival to hospital&#xD;
        discharge than compression rates of 110 or 120 per minute.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>Factorial Assignment</intervention_model>
      <intervention_model_description>We propose a factorial-design, cluster randomized controlled trial. In brief, this means that two interventions (the type of rescue breathing treatment and chest compression rate) will be studied in the same patient; and that randomizing patients to these treatments will switch over various time periods between groups of fire departments in King County. That is, some fire departments will be performing BVM with a compression rate of 100 compressions per minute over a specified time period, and will thereafter switch to the i-gel and a different chest compression rate for a specified time period.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Survival to Hospital Discharge</measure>
      <time_frame>This outcome typically occurs days to weeks after Cardiac Arrest Event. The study will monitor for this outcome for 6 months following the cardiac arrest event.</time_frame>
      <description>The outcome will compare the proportion of subjects who survive to be discharged from the hospital. The outcome is an endorsed outcome by the Utstein guidelines and a common primary outcome in clinical resuscitation studies.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Return to Spontaneous Circulation (ROSC)</measure>
      <time_frame>This outcome occurs within minutes of the cardiac arrest event. The outcome will be monitored for 1 day from the time of cardiac arrest.</time_frame>
      <description>This outcome provides a proximal outcome of the potential differential effectiveness of the study interventions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival with favorable neurological function (CPC 1-2)</measure>
      <time_frame>This outcome typically occurs days to weeks after Cardiac Arrest Event. The study will monitor for this outcome for 6 months following the cardiac arrest event.</time_frame>
      <description>This outcome will compare the proportion of subjects who survive to be discharged from the hospital who have favorable functional status as determined by the Cerebral Performance Category. This outcome is an endorsed outcome measure by the Utstein guidelines and a common secondary or primary outcome in clinical resuscitation studies.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4200</enrollment>
    <condition>Out-Of-Hospital Cardiac Arrest</condition>
    <arm_group>
      <arm_group_label>Airway Strategy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Each of 28 first responder EMS agencies in King County will be randomly assigned to treat with either the BVM or i-gel for airway strategy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Compression Rate</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Each of 28 first responder EMS agencies in King County will be randomly assigned with one of the three chest compression rates (100 vs 110 vs 120) at the outset.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>igel</intervention_name>
      <description>First responder ventilation strategy. First responders in King County routinely use the BVM as part of core treatment of SCA. As part of EMS training, we have introduced a training module for use of the igel in simulated resuscitation, which has been enthusiastically accepted by EMS leadership and providers. The i-gel is already successfully practiced by BLS providers in a number of other communities and challenges in training and clinical application will be monitored, but not anticipated.</description>
      <arm_group_label>Airway Strategy</arm_group_label>
      <other_name>airway management</other_name>
      <other_name>Bag Valve Mask</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Compression Rate</intervention_name>
      <description>Compression rates. The EMS system routinely measures EMS CPR performance and specifically the chest compression rate using information derived and electronically recorded from defibrillator patches. As detailed in the Background section, this CPR surveillance activity highlights the variability of compression rates across the guideline-directed range of 100-120 compressions per minute. In addition our CPR surveillance indicates that a metronome can be used to obtain and maintain a specific compression rate within the parameters specified by this trial. This will be the tool used to guide compliance with the assigned chest compression rate by on-scene providers.</description>
      <arm_group_label>Compression Rate</arm_group_label>
      <other_name>CPR</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults suffering out-of-hospital non-traumatic SCA in Seattle and greater King County&#xD;
               in whom resuscitation will be attempted by first responding EMS personnel.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  if advanced paramedic providers are first on-scene and have already initiated advanced&#xD;
               life support (ALS) procedures,&#xD;
  &#xD;
            -  a written advance directive (do not attempt resuscitation orders),&#xD;
  &#xD;
            -  traumatic arrest (blunt, penetrating, burn),&#xD;
  &#xD;
            -  known prisoner,&#xD;
  &#xD;
            -  known pregnancy,&#xD;
  &#xD;
            -  other protected populations (pediatrics),&#xD;
  &#xD;
            -  pre-existing tracheostomy,&#xD;
  &#xD;
            -  recipients of mechanical ventilator support, or&#xD;
  &#xD;
            -  presence of an &quot;opt out&quot; bracelet to not be enrolled in clinical trials.&#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>Thomas Rea, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jenny B Shin</last_name>
      <phone>206-263-8586</phone>
      <email>jennys2@uw.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Thomas Rea</investigator_full_name>
      <investigator_title>Professor, School of Medicine</investigator_title>
    </responsible_party>
    <keyword>Airway Management</keyword>
    <keyword>CPR</keyword>
    <keyword>Emergency Medical Services</keyword>
    <keyword>Basic Life Support</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969028
  org study id: STUDY00014110
  nct id: NCT05969028
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The First responder Airway & Compression rate Trial (FACT) Study will address basic life
        support (BLS) treatments administered by Emergency Medical Services (EMS) first responders to
        patients who suffer a sudden circulatory (pulseless) collapse, referred to as sudden
        out-of-hospital cardiac arrest (SCA). The investigators propose a randomized controlled trial
        among persons who suffer SCA to compare these two rescue breathing approaches (standard Bag
        Valve Mask vs i-gel) along with evaluating a more precise chest compression rate within the
        range of 100-120 compressions per minute during CPR. Importantly, each of these treatments
        fall within established resuscitation guidelines and are already administered as part of
        standard care in clinical practice. Thus this proposed trial will essentially be comparing
        one standard-of-care treatment against another standard-of-care treatment.
  
        The study will address two primary aims:
  
        Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM
        versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will
        result in a higher rate of survival to hospital discharge than BVM.
  
        Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest
        compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment
        with 100 chest compressions per minute will result in a higher rate of survival to hospital
        discharge than compression rates of 110 or 120 per minute.
  The First responder Airway & Compression rate Trial (FACT) Study will address basic life
        support (BLS) treatments administered by EMS first responders to patients who suffer a sudden
        circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac arrest (SCA).
        The current standard of practice for first responder CPR includes chest compressions at a
        rate of 100-120 compressions per minute combined with rescue breathing using either a bag
        valve mask (BVM) or a type of oral airway called an i-gel. During rescue breathing with a
        BVM, a mask is attached to a breathing bag and placed over the patient's face. The BVM
        provides oxygen and clears carbon dioxide out of the lungs by blowing air through the
        patient's mouth. Alternatively, the i-gel consists of a short tube which is inserted in the
        back of the patient's throat. This tube blows oxygen more directly into the lungs, bypassing
        the mouth itself. Each of these breathing methods is considered standard of care treatment by
        EMS first responders. Standard of care means each method is commonly used to treat patients
        in cardiac arrest and is performed regularly, depending upon the community in which the
        cardiac arrest has occurred. The other component of CPR is chest compressions. The American
        Heart Association has recommended a chest compression rate during CPR of between 100-120
        compressions per minute, but has not specified an ideal exact compression rate within this
        range. Scientific studies in both animals and clinical studies have shown that these
        different standard-of-care approaches to ventilation and the compression rate can produce
        different physiologic effects (such as the adequacy of rescue breathing and blood flow) that
        could impact clinical outcome. The investigators propose a randomized controlled trial among
        persons who suffer SCA to compare these two rescue breathing approaches along with evaluating
        a more precise chest compression rate within the range of 100-120 compressions per minute
        during CPR. Importantly, each of these treatments fall within established resuscitation
        guidelines and are already administered as part of standard care in clinical practice. Thus
        this proposed trial will essentially be comparing one standard-of-care treatment against
        another standard-of-care treatment.
  
        The study will address two primary aims:
  
        Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM
        versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will
        result in a higher rate of survival to hospital discharge than BVM.
  
        Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest
        compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment
        with 100 chest compressions per minute will result in a higher rate of survival to hospital
        discharge than compression rates of 110 or 120 per minute.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: We propose a factorial-design, cluster randomized controlled trial. In brief, this means that two interventions (the type of rescue breathing treatment and chest compression rate) will be studied in the same patient; and that randomizing patients to these treatments will switch over various time periods between groups of fire departments in King County. That is, some fire departments will be performing BVM with a compression rate of 100 compressions per minute over a specified time period, and will thereafter switch to the i-gel and a different chest compression rate for a specified time period.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Survival to Hospital Discharge
  time frame: This outcome typically occurs days to weeks after Cardiac Arrest Event. The study will monitor for this outcome for 6 months following the cardiac arrest event.
  description: The outcome will compare the proportion of subjects who survive to be discharged from the hospital. The outcome is an endorsed outcome by the Utstein guidelines and a common primary outcome in clinical resuscitation studies.
  measure: Return to Spontaneous Circulation (ROSC)
  time frame: This outcome occurs within minutes of the cardiac arrest event. The outcome will be monitored for 1 day from the time of cardiac arrest.
  description: This outcome provides a proximal outcome of the potential differential effectiveness of the study interventions.
  measure: Survival with favorable neurological function (CPC 1-2)
  time frame: This outcome typically occurs days to weeks after Cardiac Arrest Event. The study will monitor for this outcome for 6 months following the cardiac arrest event.
  description: This outcome will compare the proportion of subjects who survive to be discharged from the hospital who have favorable functional status as determined by the Cerebral Performance Category. This outcome is an endorsed outcome measure by the Utstein guidelines and a common secondary or primary outcome in clinical resuscitation studies.
  arm group label: Airway Strategy
  arm group type: Active Comparator
  description: Each of 28 first responder EMS agencies in King County will be randomly assigned to treat with either the BVM or i-gel for airway strategy
  arm group label: Compression Rate
  arm group type: Active Comparator
  description: Each of 28 first responder EMS agencies in King County will be randomly assigned with one of the three chest compression rates (100 vs 110 vs 120) at the outset.
  intervention type: Device
  intervention name: igel
  description: First responder ventilation strategy. First responders in King County routinely use the BVM as part of core treatment of SCA. As part of EMS training, we have introduced a training module for use of the igel in simulated resuscitation, which has been enthusiastically accepted by EMS leadership and providers. The i-gel is already successfully practiced by BLS providers in a number of other communities and challenges in training and clinical application will be monitored, but not anticipated.
  arm group label: Airway Strategy
  other name: airway management
  other name: Bag Valve Mask
  intervention type: Procedure
  intervention name: Compression Rate
  description: Compression rates. The EMS system routinely measures EMS CPR performance and specifically the chest compression rate using information derived and electronically recorded from defibrillator patches. As detailed in the Background section, this CPR surveillance activity highlights the variability of compression rates across the guideline-directed range of 100-120 compressions per minute. In addition our CPR surveillance indicates that a metronome can be used to obtain and maintain a specific compression rate within the parameters specified by this trial. This will be the tool used to guide compliance with the assigned chest compression rate by on-scene providers.
  arm group label: Compression Rate
  other name: CPR
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas Rea, MD
  role: Principal Investigator
  affiliation: University of Washington
  last name: Jenny B Shin
  phone: 206-263-8586
  email: jennys2@uw.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Thomas Rea
  investigator title: Professor, School of Medicine
  mesh term: Out-of-Hospital Cardiac Arrest