<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/NCT02998307</url>
  </required_header>
  <id_info>
    <org_study_id>16-010</org_study_id>
    <nct_id>NCT02998307</nct_id>
  </id_info>
  <brief_title>Optimal Training Frequency for Attainment and Maintenance of High-quality CPR on a High-fidelity Manikin</brief_title>
  <official_title>Optimal Serial Training Frequency for Attainment and Maintenance of High Quality CPR Using Real-Time Automated Performance Feedback Combined With Verbal Feedback From a CPR Instructor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Sciences North</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal College of Physicians and Surgeons of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Health Sciences North</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: The primary objective is to determine the least frequent CPR training interval&#xD;
      associated with continued performance of guideline-compliant CPR. The secondary objective is&#xD;
      to determine whether certain physical characteristics, such as age, gender, exercise&#xD;
      tolerance, height, and weight may be able to identify HCPs at high risk of being unable to&#xD;
      perform high-quality CPR.&#xD;
&#xD;
      Design: Randomized trial to compare the effect of different training frequencies on long-term&#xD;
      CPR performance.&#xD;
&#xD;
      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects&#xD;
      will be randomly assigned to a group that undertakes short CPR assessment and training&#xD;
      sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months&#xD;
      (control group) over the course of a twelve-month period.&#xD;
&#xD;
      Analysis: The proportion of nurses in each group that is able to perform &quot;excellent CPR&quot; at&#xD;
      the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR&#xD;
      session where 90% of compressions are performed with correct depth (50-60 mm), 90% with&#xD;
      correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be&#xD;
      performed where the demographic data of individuals who are unable to perform excellent CPR&#xD;
      at the twelve-month time point regardless of intervention group are compared against those&#xD;
      who are successful.&#xD;
&#xD;
      Conclusion: The results of our study will help determine the longest CPR training interval&#xD;
      associated with maintenance of high-quality CPR skills to minimize training sessions required&#xD;
      and decrease associated costs. The results will also generate hypotheses for future study&#xD;
      about optimizing role assignments and team performance in resuscitation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">January 8, 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of nurses in each group able to perform &quot;excellent CPR&quot; after completing CPR training programs of various frequencies</measure>
    <time_frame>12 months</time_frame>
    <description>&quot;Excellent CPR&quot; is a dichotomous variable achieved if 90% of compressions are performed with correct depth (50-60 mm), 90% with correct rate (100-120 /min), and 90% with full chest recoil.&#xD;
The proportion of nurses in each group able to perform &quot;excellent CPR&quot; after completing CPR training programs of various frequencies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictors of inability to perform high-quality CPR</measure>
    <time_frame>12 months</time_frame>
    <description>Comparison of the following factors in participants able to perform &quot;excellent CPR&quot; and those who are not at the twelve-month time point: percentage of participants who are female or have self-declared shortness of breath when climbing two flights of stairs, and average age, height and weight.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Simulation Training</condition>
  <arm_group>
    <arm_group_label>Monthly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive bedside CPR training monthly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive bedside CPR training every 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive bedside CPR training every 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No additional training and only performance evaluation after 1 year</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPR Training</intervention_name>
    <description>Brief CPR assessment and training done during working hours with real-time performance feedback</description>
    <arm_group_label>3 months</arm_group_label>
    <arm_group_label>6 months</arm_group_label>
    <arm_group_label>Monthly</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Practicing nurses from multiple clinical environments (operating room, intensive care&#xD;
             unit, emergency room, medical and surgical wards) at Health Sciences North.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Health Sciences North</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 5J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02998307
org study id: 16-010
nct id: NCT02998307
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Objectives: The primary objective is to determine the least frequent CPR training interval
      associated with continued performance of guideline-compliant CPR. The secondary objective is
      to determine whether certain physical characteristics, such as age, gender, exercise
      tolerance, height, and weight may be able to identify HCPs at high risk of being unable to
      perform high-quality CPR.

      Design: Randomized trial to compare the effect of different training frequencies on long-term
      CPR performance.

      Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects
      will be randomly assigned to a group that undertakes short CPR assessment and training
      sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months
      (control group) over the course of a twelve-month period.

      Analysis: The proportion of nurses in each group that is able to perform "excellent CPR" at
      the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR
      session where 90% of compressions are performed with correct depth (50-60 mm), 90% with
      correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be
      performed where the demographic data of individuals who are unable to perform excellent CPR
      at the twelve-month time point regardless of intervention group are compared against those
      who are successful.

      Conclusion: The results of our study will help determine the longest CPR training interval
      associated with maintenance of high-quality CPR skills to minimize training sessions required
      and decrease associated costs. The results will also generate hypotheses for future study
      about optimizing role assignments and team performance in resuscitation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Proportion of nurses in each group able to perform "excellent CPR" after completing CPR training programs of various frequencies
time frame: 12 months
description: "Excellent CPR" is a dichotomous variable achieved if 90% of compressions are performed with correct depth (50-60 mm), 90% with correct rate (100-120 /min), and 90% with full chest recoil.
The proportion of nurses in each group able to perform "excellent CPR" after completing CPR training programs of various frequencies.
measure: Predictors of inability to perform high-quality CPR
time frame: 12 months
description: Comparison of the following factors in participants able to perform "excellent CPR" and those who are not at the twelve-month time point: percentage of participants who are female or have self-declared shortness of breath when climbing two flights of stairs, and average age, height and weight.
arm group label: Monthly
arm group type: Experimental
description: Receive bedside CPR training monthly
arm group label: 3 months
arm group type: Experimental
description: Receive bedside CPR training every 3 months
arm group label: 6 months
arm group type: Experimental
description: Receive bedside CPR training every 6 months
arm group label: Control
arm group type: No Intervention
description: No additional training and only performance evaluation after 1 year
intervention type: Procedure
intervention name: CPR Training
description: Brief CPR assessment and training done during working hours with real-time performance feedback
arm group label: 3 months
arm group label: 6 months
arm group label: Monthly
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No