<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/NCT03230461</url>
  </required_header>
  <id_info>
    <org_study_id>19575</org_study_id>
    <nct_id>NCT03230461</nct_id>
  </id_info>
  <brief_title>Estimation of CPR Chest Compression Depth</brief_title>
  <official_title>Can Rescuers Accurately Deliver Subtle Changes to Chest Compression Depth if Recommended by Future Guidelines?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</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>
      Optimal chest compression depth during CPR is 4.56cm which is at variance with the current&#xD;
      guidelines of 5.0-6.0cm. A change in guidelines is only worthwhile if healthcare&#xD;
      professionals can accurately judge a subtle reduction in chest compression depth during CPR&#xD;
      by a relatively small amount.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chest compression depth and rate during cardiopulmonary resuscitation (CPR) are important&#xD;
      predictors of return of spontaneous circulation and survival following cardiac arrest. Stiell&#xD;
      et al (2014) found optimal survival at a compression depth of 4.56cm, which is at variance&#xD;
      with the current guidelines of 5.0-6.0cm. A change in guidelines is only likely to improve&#xD;
      survival rates if healthcare professionals can accurately implement these subtle depth&#xD;
      modifications into the basic life support (BLS) algorithm. This study aims to determine if&#xD;
      healthcare professionals can accurately judge compression depth without real-time feedback.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">August 7, 2017</completion_date>
  <primary_completion_date type="Actual">August 7, 2017</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Prospective, randomised.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants and researchers are blinded to the actual depth achieved during each CPR run.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Compression to target window depth</measure>
    <time_frame>Two minutes</time_frame>
    <description>Mean compression depth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compression to target rate</measure>
    <time_frame>Two minutes</time_frame>
    <description>Mean compression rate</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Target compression depth 4.0-5.0 cm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Target compression depth 4.5-5.5 cm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Target compression depth 5.0-6.0 cm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Compression depth</intervention_name>
    <arm_group_label>Target compression depth 4.0-5.0 cm</arm_group_label>
    <arm_group_label>Target compression depth 4.5-5.5 cm</arm_group_label>
    <arm_group_label>Target compression depth 5.0-6.0 cm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NHS professionals (staff or students), who have successfully completed a&#xD;
             hospital-accredited basic life support (BLS) course, including a practical CPR&#xD;
             component.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, significant medical illness or injury that would impair delivery of chest&#xD;
             compressions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Deakin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Southampton</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CPR</keyword>
  <keyword>Basic life support</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>Undecided</sharing_ipd>
    <ipd_description>Available on request</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/NCT03230461
org study id: 19575
nct id: NCT03230461
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Optimal chest compression depth during CPR is 4.56cm which is at variance with the current
      guidelines of 5.0-6.0cm. A change in guidelines is only worthwhile if healthcare
      professionals can accurately judge a subtle reduction in chest compression depth during CPR
      by a relatively small amount.
Chest compression depth and rate during cardiopulmonary resuscitation (CPR) are important
      predictors of return of spontaneous circulation and survival following cardiac arrest. Stiell
      et al (2014) found optimal survival at a compression depth of 4.56cm, which is at variance
      with the current guidelines of 5.0-6.0cm. A change in guidelines is only likely to improve
      survival rates if healthcare professionals can accurately implement these subtle depth
      modifications into the basic life support (BLS) algorithm. This study aims to determine if
      healthcare professionals can accurately judge compression depth without real-time feedback.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Prospective, randomised.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants and researchers are blinded to the actual depth achieved during each CPR run.
measure: Compression to target window depth
time frame: Two minutes
description: Mean compression depth
measure: Compression to target rate
time frame: Two minutes
description: Mean compression rate
arm group label: Target compression depth 4.0-5.0 cm
arm group type: Experimental
description: The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min
arm group label: Target compression depth 4.5-5.5 cm
arm group type: Experimental
description: The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min
arm group label: Target compression depth 5.0-6.0 cm
arm group type: Experimental
description: The rescuer is asked to perform two minutes of chest compressions on a manikin, aiming to compress to the target depth at a rate of 100-120/min
intervention type: Behavioral
intervention name: Compression depth
arm group label: Target compression depth 4.0-5.0 cm
arm group label: Target compression depth 4.5-5.5 cm
arm group label: Target compression depth 5.0-6.0 cm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Deakin, MD
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: Undecided
ipd description: Available on request