<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/NCT04422938</url>
  </required_header>
  <id_info>
    <org_study_id>medybu-IN</org_study_id>
    <nct_id>NCT04422938</nct_id>
  </id_info>
  <brief_title>Mechanical Versus Manual Cardiopulmonary Resuscitation</brief_title>
  <official_title>Mechanical Versus Manual Chest Compression: A Retrospective Study in In-hospital Cardiac Arrest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ankara Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ankara City Hospital Bilkent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators compared mechanical and manual chest compressions in&#xD;
      in-hospital cardiac arrest cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators analyzed cardiopulmonary resuscitations performed over a&#xD;
      2-year period in an emergency department of a training and research hospital and compared&#xD;
      success of manual and mechanical chest compressions in terms of return of spontaneous&#xD;
      circulation, 30-day survival, and hospital discharge. Investigators present the study as an&#xD;
      in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases&#xD;
      included in the study were performed in the emergency department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate on the 30th day</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality rates from the hospital admission to the 30th day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of the return of spontaneous circulation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Rate of return of the spontaneous circulation with duration at least five minutes</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">303</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Resuscitation</condition>
  <arm_group>
    <arm_group_label>Manuel compression</arm_group_label>
    <description>Manuel chest compressions will be handled by clinicians</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mechanical compression</arm_group_label>
    <description>Mechanical chest compressions will be handled via mechanical chest compression device</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manuel chest compressions handled by clinicians</intervention_name>
    <description>Compressions will be handled by human efforts</description>
    <arm_group_label>Manuel compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LUCAS™ 2 Chest Compression System</intervention_name>
    <description>LUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions</description>
    <arm_group_label>Mechanical compression</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cases with cardiac arrest in-hospital environment (in emergency department) and whose had&#xD;
        manual or mechanical cardiopulmonary resuscitation in emergency department included in the&#xD;
        study; data were collected hospital management information system and analyzed&#xD;
        retropectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Over 18 age Cardiac arrest cases In-hospital cardiac arrest cases Resuscitations performed&#xD;
        in emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &lt;18 age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University, School of Medicine, Department of Emergency Medicine</name>
      <address>
        <city>Ankara</city>
        <state>Çankaya</state>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Couper K, Yeung J, Nicholson T, Quinn T, Lall R, Perkins GD. Mechanical chest compression devices at in-hospital cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Jun;103:24-31. doi: 10.1016/j.resuscitation.2016.03.004. Epub 2016 Mar 11.</citation>
    <PMID>26976675</PMID>
  </reference>
  <reference>
    <citation>Couper K, Quinn T, Lall R, Devrell A, Orriss B, Seers K, Yeung J, Perkins GD; COMPRESS-RCT collaborators. Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT). Scand J Trauma Resusc Emerg Med. 2018 Aug 30;26(1):70. doi: 10.1186/s13049-018-0538-6.</citation>
    <PMID>30165909</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>Alp Şener</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiopulmonary Resuscitation</keyword>
  <keyword>Chest compression</keyword>
  <keyword>In-hospital</keyword>
  <keyword>Mechanical</keyword>
  <keyword>Manuel</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>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data (IPD) with other researchers.</ipd_description>
  </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/NCT04422938
org study id: medybu-IN
nct id: NCT04422938
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
In this study, the investigators compared mechanical and manual chest compressions in
      in-hospital cardiac arrest cases.
In this study, the investigators analyzed cardiopulmonary resuscitations performed over a
      2-year period in an emergency department of a training and research hospital and compared
      success of manual and mechanical chest compressions in terms of return of spontaneous
      circulation, 30-day survival, and hospital discharge. Investigators present the study as an
      in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases
      included in the study were performed in the emergency department.
observational model: Cohort
time perspective: Retrospective
measure: Mortality rate on the 30th day
time frame: 30 days
description: Mortality rates from the hospital admission to the 30th day
measure: Rate of the return of spontaneous circulation
time frame: 5 minutes
description: Rate of return of the spontaneous circulation with duration at least five minutes
arm group label: Manuel compression
description: Manuel chest compressions will be handled by clinicians
arm group label: Mechanical compression
description: Mechanical chest compressions will be handled via mechanical chest compression device
intervention type: Other
intervention name: Manuel chest compressions handled by clinicians
description: Compressions will be handled by human efforts
arm group label: Manuel compression
intervention type: Device
intervention name: LUCAS™ 2 Chest Compression System
description: LUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions
arm group label: Mechanical compression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
citation: Couper K, Yeung J, Nicholson T, Quinn T, Lall R, Perkins GD. Mechanical chest compression devices at in-hospital cardiac arrest: A systematic review and meta-analysis. Resuscitation. 2016 Jun;103:24-31. doi: 10.1016/j.resuscitation.2016.03.004. Epub 2016 Mar 11.
PMID: 26976675
citation: Couper K, Quinn T, Lall R, Devrell A, Orriss B, Seers K, Yeung J, Perkins GD; COMPRESS-RCT collaborators. Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm: a randomised controlled feasibility trial (COMPRESS-RCT). Scand J Trauma Resusc Emerg Med. 2018 Aug 30;26(1):70. doi: 10.1186/s13049-018-0538-6.
PMID: 30165909
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: Alp Şener
investigator title: Clinical Assistant Professor
mesh term: Heart Arrest
sharing ipd: No
ipd description: There is no plan to share individual participant data (IPD) with other researchers.