<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/NCT03238287</url>
  </required_header>
  <id_info>
    <org_study_id>3939444</org_study_id>
    <secondary_id>2016-1385</secondary_id>
    <nct_id>NCT03238287</nct_id>
  </id_info>
  <brief_title>Manual and Mechanical Chest Compression During In-hospital Witnessed Cardiac Arrests Using Cerebral Oximetry</brief_title>
  <official_title>Evaluation of Effectiveness of Cardiopulmonary Resuscitation With Manual and Mechanical Chest Compression Systems During In-hospital (at the Emergency Department) Witnessed Cardiac Arrests Using Cerebral Oximetry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scientific Research Projects Commission of ESOGU</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eskisehir Osmangazi University</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>
      Post-resuscitation neurological impairment is associated with morbidity and especially with&#xD;
      late mortality. Thus, because good neurological outcome is vital for a successful&#xD;
      resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation&#xD;
      during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such&#xD;
      conditions. NIRS is a non-invasive technique which provides real-time, continuous information&#xD;
      about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS&#xD;
      has been done in many studies including cardiovascular surgery, neurosurgery and their&#xD;
      intensive care processes and its effectiveness has been approved. However, there is limited&#xD;
      data on its use in cardiac arrests.&#xD;
&#xD;
      As stated in the current guidelines, sufficient speed and depth of chest compressions, few&#xD;
      interruptions of compressions are key to a successful outcome of resuscitation. The studies&#xD;
      with the mechanical chest compression devices showed that the earlier it was applied in&#xD;
      out-of-hospital cases, the higher the rates of survival until hospitalization. There is not&#xD;
      sufficient number of studies on the routine use of mechanical chest compression devices for&#xD;
      in-hospital cases. In case the application of manual resuscitation is not convenient (during&#xD;
      patient relocation, procedure at the angiography laboratory, and rush hours of emergency&#xD;
      services when staff might fall short), alternative methods will be required.&#xD;
&#xD;
      The aim of our study is to compare rSO2 levels measured during resuscitation with manual and&#xD;
      mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest&#xD;
      cases and to analyze the impact of both application method and perfusion levels on survival&#xD;
      and neurological outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a single-center, prospective and randomized study. It will be conducted at&#xD;
      the Emergency Department of Eskisehir Osmangazi University Education, Application and&#xD;
      Research Hospital.&#xD;
&#xD;
      Patients will be allocated to treatment groups by blocked randomization (www.randomizer.org).&#xD;
      Advanced cardiac life support algorithm will be initiated as outlined in the current&#xD;
      resuscitation guidelines and cardiopulmonary resuscitation (CPR) will be continued either&#xD;
      manually or mechanically (with the chest compression system), according to the randomization&#xD;
      scheme. Due to the nature of the interventions carried out in the study process, blinding of&#xD;
      healthcare providers was not possible.&#xD;
&#xD;
      Before the initiation of the study, the team members participating in the study will receive&#xD;
      theoretical and practical training on CPR, mechanical chest compression system utilization&#xD;
      and NIRS.&#xD;
&#xD;
      Patients who develop cardiopulmonary arrest during their clinical evaluation in the emergency&#xD;
      department will receive CPR, and the chest compression method will be determined by the&#xD;
      senior physician according to the randomization scheme.&#xD;
&#xD;
        1. The manual CPR group will receive chest compressions, respiratory support and medical&#xD;
           treatment in accordance with the recommendations of current guidelines. If return of&#xD;
           spontaneous circulation (ROSC) is achieved, post-resuscitation care will be provided. If&#xD;
           ROSC is not achieved, CPR will be terminated in accordance with the recommendations of&#xD;
           current guidelines.&#xD;
&#xD;
        2. The patients on the mechanical chest compression group will receive manual chest&#xD;
           compressions until the mechanical compression device is installed (about 15-20 seconds).&#xD;
           In this time interval, thorax and sternum measurements will be evaluated for suitability&#xD;
           for the study, and mechanical compression device will be installed on patients who are&#xD;
           deemed suitable. The patients will receive chest compressions, respiratory support and&#xD;
           medical treatment in accordance with the recommendations of current guidelines. If ROSC&#xD;
           is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will&#xD;
           be terminated in accordance with the recommendations of current guidelines.&#xD;
&#xD;
      The presence of ROSC or the decision to terminate CPR will be determined according to the&#xD;
      vital signs (arterial blood pressure, heart rate, oxygen saturation with pulse oximeter), end&#xD;
      tidal carbon dioxide (ETco2) measurement (with the module device used for the measurement of&#xD;
      rSO2) and cardiac assessment with bedside ultrasonography (Vivid e, General Electric&#xD;
      Healthcare, China).&#xD;
&#xD;
      As soon as cardiopulmonary arrest is identified, sensors measuring the value of rSO2 will be&#xD;
      placed on the patient's head bifrontally (forehead area) in order to measure the cerebral&#xD;
      perfusion. During CPR, rSO2 values will be continuously recorded. The placement of the&#xD;
      sensors and the measurements will be carried out by a medical staff who received necessary&#xD;
      training prior to the study. In order not to affect the clinical decisions made during CPR,&#xD;
      the rSO2 device will be placed in a convenient area which is out of the CPR performers'&#xD;
      eyesight.&#xD;
&#xD;
      Arterial blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation on&#xD;
      pulse oximeter, primary arrest rhythm, any known diseases (if existent) and defibrillation&#xD;
      attempts (if existent) will be recorded on the case report form during CPR.&#xD;
&#xD;
      In patients with ROSC, 6-hour and 24-hour survival after CPR, discharge from the hospital&#xD;
      with favorable neurologic outcome and the presence of additional pathologies (such as heart&#xD;
      failure and neurologic sequelae) will be evaluated. Favorable neurologic outcome was defined&#xD;
      as a Cerebral Performance Category score of 1-2. In patients with ROSC, post-resuscitation&#xD;
      care will be provided as recommended in the current guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Regional cerebral tissue oxygen saturation level</measure>
    <time_frame>20-45 second</time_frame>
    <description>Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival at the 6th hour and 24th hour after resuscitation,</measure>
    <time_frame>6th hour and 24th hours</time_frame>
    <description>Survival at the 6th hour and 24th hour after resuscitation and evaluation of neurological outcome (cerebral performance category scale 1-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital discharge</measure>
    <time_frame>1- 30 days</time_frame>
    <description>Hospital discharge with good neurological outcome (cerebral performance category scale 1-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional pathology</measure>
    <time_frame>1- 30 days</time_frame>
    <description>Evaluation of additional pathology (e.g., renal failure and cardiac failure) after resuscitation during in-hospital observation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Cardiopulmonary Resuscitation</condition>
  <arm_group>
    <arm_group_label>Manuel chest compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mechanical chest compression</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical chest compression</intervention_name>
    <description>In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.</description>
    <arm_group_label>Mechanical chest compression</arm_group_label>
    <other_name>LUCAS2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manuel chest compression</intervention_name>
    <description>In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines</description>
    <arm_group_label>Manuel chest compression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years or older.&#xD;
&#xD;
          2. In hospital (emergency service) witnessed cardiac arrest.&#xD;
&#xD;
          3. Cardiac arrest caused reasons other than trauma.&#xD;
&#xD;
          4. Length of sternum between 170- 303 mm (devise requirements).&#xD;
&#xD;
          5. Patients' chest width not more than 449 mm (devise requirements).&#xD;
&#xD;
          6. Informed consent of first-degree relatives of patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 18 years old.&#xD;
&#xD;
          2. Out-of-hospital cardiac arrest.&#xD;
&#xD;
          3. Exposure to trauma.&#xD;
&#xD;
          4. Pregnancy.&#xD;
&#xD;
          5. Length of sternum not between 170- 303 mm (devise requirements).&#xD;
&#xD;
          6. Patients' chest width more than 449 mm (devise requirements).&#xD;
&#xD;
          7. Intracranial mass, large infarct or bleeding in the frontal part of the head (rSO2&#xD;
             monitoring area) which might effect the evaluation.&#xD;
&#xD;
          8. Lack of informed consent of first-degree relatives of patients.&#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>Filiz Baloğlu Kaya</last_name>
    <role>Study Chair</role>
    <affiliation>Eskisehir Osmangazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskisehir Osmangazi University Medical School</name>
      <address>
        <city>Eskişehir</city>
        <zip>26000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Filiz Baloglu Kaya</investigator_full_name>
    <investigator_title>Ass.Prof.</investigator_title>
  </responsible_party>
  <keyword>Emergency</keyword>
  <keyword>Mechanical chest compression</keyword>
  <keyword>Cerebral oximetry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participants data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be available within one year of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the principal investigator of the study. Requestors will be required to sign a Data Access Agreement.</ipd_access_criteria>
  </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/NCT03238287
org study id: 3939444
secondary id: 2016-1385
nct id: NCT03238287
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-resuscitation neurological impairment is associated with morbidity and especially with
      late mortality. Thus, because good neurological outcome is vital for a successful
      resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation
      during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such
      conditions. NIRS is a non-invasive technique which provides real-time, continuous information
      about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS
      has been done in many studies including cardiovascular surgery, neurosurgery and their
      intensive care processes and its effectiveness has been approved. However, there is limited
      data on its use in cardiac arrests.

      As stated in the current guidelines, sufficient speed and depth of chest compressions, few
      interruptions of compressions are key to a successful outcome of resuscitation. The studies
      with the mechanical chest compression devices showed that the earlier it was applied in
      out-of-hospital cases, the higher the rates of survival until hospitalization. There is not
      sufficient number of studies on the routine use of mechanical chest compression devices for
      in-hospital cases. In case the application of manual resuscitation is not convenient (during
      patient relocation, procedure at the angiography laboratory, and rush hours of emergency
      services when staff might fall short), alternative methods will be required.

      The aim of our study is to compare rSO2 levels measured during resuscitation with manual and
      mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest
      cases and to analyze the impact of both application method and perfusion levels on survival
      and neurological outcome.
The study will be a single-center, prospective and randomized study. It will be conducted at
      the Emergency Department of Eskisehir Osmangazi University Education, Application and
      Research Hospital.

      Patients will be allocated to treatment groups by blocked randomization (www.randomizer.org).
      Advanced cardiac life support algorithm will be initiated as outlined in the current
      resuscitation guidelines and cardiopulmonary resuscitation (CPR) will be continued either
      manually or mechanically (with the chest compression system), according to the randomization
      scheme. Due to the nature of the interventions carried out in the study process, blinding of
      healthcare providers was not possible.

      Before the initiation of the study, the team members participating in the study will receive
      theoretical and practical training on CPR, mechanical chest compression system utilization
      and NIRS.

      Patients who develop cardiopulmonary arrest during their clinical evaluation in the emergency
      department will receive CPR, and the chest compression method will be determined by the
      senior physician according to the randomization scheme.

        1. The manual CPR group will receive chest compressions, respiratory support and medical
           treatment in accordance with the recommendations of current guidelines. If return of
           spontaneous circulation (ROSC) is achieved, post-resuscitation care will be provided. If
           ROSC is not achieved, CPR will be terminated in accordance with the recommendations of
           current guidelines.

        2. The patients on the mechanical chest compression group will receive manual chest
           compressions until the mechanical compression device is installed (about 15-20 seconds).
           In this time interval, thorax and sternum measurements will be evaluated for suitability
           for the study, and mechanical compression device will be installed on patients who are
           deemed suitable. The patients will receive chest compressions, respiratory support and
           medical treatment in accordance with the recommendations of current guidelines. If ROSC
           is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will
           be terminated in accordance with the recommendations of current guidelines.

      The presence of ROSC or the decision to terminate CPR will be determined according to the
      vital signs (arterial blood pressure, heart rate, oxygen saturation with pulse oximeter), end
      tidal carbon dioxide (ETco2) measurement (with the module device used for the measurement of
      rSO2) and cardiac assessment with bedside ultrasonography (Vivid e, General Electric
      Healthcare, China).

      As soon as cardiopulmonary arrest is identified, sensors measuring the value of rSO2 will be
      placed on the patient's head bifrontally (forehead area) in order to measure the cerebral
      perfusion. During CPR, rSO2 values will be continuously recorded. The placement of the
      sensors and the measurements will be carried out by a medical staff who received necessary
      training prior to the study. In order not to affect the clinical decisions made during CPR,
      the rSO2 device will be placed in a convenient area which is out of the CPR performers'
      eyesight.

      Arterial blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation on
      pulse oximeter, primary arrest rhythm, any known diseases (if existent) and defibrillation
      attempts (if existent) will be recorded on the case report form during CPR.

      In patients with ROSC, 6-hour and 24-hour survival after CPR, discharge from the hospital
      with favorable neurologic outcome and the presence of additional pathologies (such as heart
      failure and neurologic sequelae) will be evaluated. Favorable neurologic outcome was defined
      as a Cerebral Performance Category score of 1-2. In patients with ROSC, post-resuscitation
      care will be provided as recommended in the current guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Regional cerebral tissue oxygen saturation level
time frame: 20-45 second
description: Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation
measure: Survival at the 6th hour and 24th hour after resuscitation,
time frame: 6th hour and 24th hours
description: Survival at the 6th hour and 24th hour after resuscitation and evaluation of neurological outcome (cerebral performance category scale 1-2)
measure: Hospital discharge
time frame: 1- 30 days
description: Hospital discharge with good neurological outcome (cerebral performance category scale 1-2)
measure: Additional pathology
time frame: 1- 30 days
description: Evaluation of additional pathology (e.g., renal failure and cardiac failure) after resuscitation during in-hospital observation.
arm group label: Manuel chest compression
arm group type: Active Comparator
description: In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.
arm group label: Mechanical chest compression
arm group type: Active Comparator
description: In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.
intervention type: Device
intervention name: Mechanical chest compression
description: In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.
arm group label: Mechanical chest compression
other name: LUCAS2
intervention type: Other
intervention name: Manuel chest compression
description: In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines
arm group label: Manuel chest compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Filiz Baloğlu Kaya
role: Study Chair
affiliation: Eskisehir Osmangazi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Filiz Baloglu Kaya
investigator title: Ass.Prof.
mesh term: Heart Arrest
sharing ipd: Yes
ipd description: De-identified individual participants data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be available within one year of study completion.
ipd access criteria: Data access requests will be reviewed by the principal investigator of the study. Requestors will be required to sign a Data Access Agreement.