<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/NCT02231151</url>
  </required_header>
  <id_info>
    <org_study_id>CPR Point of View</org_study_id>
    <nct_id>NCT02231151</nct_id>
  </id_info>
  <brief_title>Visual Feedback of CPR: Does Point of View Matter?</brief_title>
  <official_title>Providing Visual Feedback of Quality of CPR During Pediatric Cardiac Arrest: Does Point of View Matter?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KidSIM Simulation Program</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KidSIM Simulation Program</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will look at how accurate pediatric healthcare workers are at judging&#xD;
      quality of Cardiopulmonary Resuscitation, by observation of the chest compressions, and if&#xD;
      they are more accurate at a certain position near the patient. The investigators will do this&#xD;
      by having participants fill out a survey about the quality of the Cardiopulmonary&#xD;
      Resuscitation in several recorded resuscitation scenarios.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric cardiac arrest leads to significant productive years lost, and has a huge emotional&#xD;
      impact on families and caregivers. High quality CPR is the most important predictor for&#xD;
      outcome in cardiac arrest. Human visual observation is commonly used and important to&#xD;
      evaluate CPR quality. Interestingly, the accuracy of healthcare providers' visual assessment&#xD;
      of CPR quality is unknown.&#xD;
&#xD;
      Primary Objective: To determine the accuracy of visual CPR assessment. Secondary Objective:&#xD;
      1) To identify the optimal position relative to the patient for accurate CPR assessment. 2)&#xD;
      To determine health care practitioners' accuracy in identifying CPR errors.&#xD;
&#xD;
      Methods: We will videotape both good quality CPR and poor quality CPR in a simulated&#xD;
      resuscitation. We will record 4 videos, one depicting high quality CPR, and 3 depicting the&#xD;
      most common mistakes made when performing chest compressions, and these will be videotaped&#xD;
      from the foot, head and side of the patient. Pediatric acute care professionals will be&#xD;
      recruited to watch a randomized set of all 12 video clips, and fill out a brief and simple&#xD;
      questionnaire on their assessment of the quality of the CPR being performed.&#xD;
&#xD;
      To assess the accuracy of the CPR quality, quantitative data on the quality of the CPR being&#xD;
      performed during each of the 4 videotaped events will be captured and confirmed using a&#xD;
      Laerdal CPRcard© (depth and rate) and the paediatric simulator SimJr© (recoil).&#xD;
&#xD;
      Operative definitions:&#xD;
&#xD;
        1. Chest compression depth: defined as the maximum posterior deflection of the sternum&#xD;
           prior to chest recoil. In order to be accurate a non-compressible surface must be&#xD;
           beneath the patient. It is considered shallow is it is less than 50 mm and deep is&#xD;
           greater than 60mm. Adequate chest compression depth is defined as being between 50-60&#xD;
           mm.&#xD;
&#xD;
        2. Chest compression rate: defined as the frequency of chest compressions per minute. It is&#xD;
           considered slow if less than 100 chest compressions are performed per minute, and too&#xD;
           fast if greater than 120 compressions are performed per minute. This rate will be&#xD;
           calculated during 60 seconds intervals while chest compressions are provided. Adequate&#xD;
           chest compression rate is defined as being between 100 and 120 compressions per minute.&#xD;
&#xD;
        3. Incomplete release of compressions/Recoil: defined as &quot;leaning&quot; phenomenon in which&#xD;
           force is not completely removed during compressions. This is best reported by a simple&#xD;
           binary measure: complete or incomplete (&gt;2500g residual leaning force). Adequate recoil&#xD;
           will be complete chest wall recoil.&#xD;
&#xD;
      Primary Outcome Measures: Proportion of healthcare providers who are accurate in their visual&#xD;
      assessment of CPR quality.&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
        1. Proportion of healthcare practitioners who accurately report CPR quality from position&#xD;
           in relation to the patient (head, side and foot of bed).&#xD;
&#xD;
        2. Proportion of healthcare practitioners accurately identifying CPR errors (rate, depth,&#xD;
           recoil).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of healthcare providers who are accurate in their visual assessment of CPR quality.</measure>
    <time_frame>Data is anticipated to be presented 4 months after it is collected.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare practitioners who accurately report CPR quality from position in relation to the patient (head, side and foot of bed).</measure>
    <time_frame>Data is anticipated to be presented 4 months after data is collected.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare practitioners accurately identifying CPR errors (rate, depth, recoil).</measure>
    <time_frame>Data is anticipated to be presented about 4 months after it is collected.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>CPR Quality Assessment</condition>
  <arm_group>
    <arm_group_label>Pediatric Acute Care Professionals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals must work in ER or ICU setting regularly or rotate through this setting with up to date BLS/PALS/ACLS certification. The participants will be required to rate the CPR based on accuracy for each video shown. The type of CPR error(s) shown to the individuals will be randomized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The type of CPR error(s) shown to the individual</intervention_name>
    <description>Participants will be randomly assigned 12 videos to watch and rate the CPR quality of each. Investigators will be blind to the identity of the participants.</description>
    <arm_group_label>Pediatric Acute Care Professionals</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pediatric acute care healthcare providers: such as nurses, nurse practitioners,&#xD;
             respiratory therapists, physicians, residents, fellows&#xD;
&#xD;
          2. Those who work in ER or ICU setting regularly or rotate through this setting&#xD;
&#xD;
          3. Basic Life Support (BLS), Pediatric Advanced Life Support (PALS) or Advanced Cardiac&#xD;
             Life Support (ACLS) certification within the past two years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anyone who has participated previously in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Cheng, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KidSim-Aspire Simulation Research Lab, Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Sutton R, Niles D, Nysaether J et al. Quantitative Analysis of CPR quality during in-hospital resuscitation of older children and adolescents. Pediatrics. 2009; 124 : 1930-8. Sutton R, Maltese M, Niles D et al. Quantitative analysis of chest compression interruption during in-hospital resuscitation of older children and adolescents. Resuscitation 2009; 80:1259-1263. Atkins DL et al. Epidemiology and Outcomes From Out-of-Hospital Cardiac Arrest in Children: The Resuscitation Outcomes Consortium Epistry-Cardiac Arrest. Circulation. 2009;119:1484-91. Atkins DL, Everson-Stewart S, Sears GK, Daya M, Osmond MH, Warden CR, Berg RA. Epidemiology and outcomes from out-of-hospital cardiac arrest in children: the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest. Circulation. 2009;119:1484-1491.</citation>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>August 4, 2015</last_update_submitted>
  <last_update_submitted_qc>August 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KidSIM Simulation Program</investigator_affiliation>
    <investigator_full_name>Nicola Robertson</investigator_full_name>
    <investigator_title>KidSim Aspire Coordinator</investigator_title>
  </responsible_party>
  <keyword>CPR quality assessment</keyword>
  <keyword>Visual CPR assessment</keyword>
  <keyword>Position relative to patient</keyword>
  <!-- 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/NCT02231151
org study id: CPR Point of View
nct id: NCT02231151
lead sponsor: 
has dmc: No
The investigators will look at how accurate pediatric healthcare workers are at judging
      quality of Cardiopulmonary Resuscitation, by observation of the chest compressions, and if
      they are more accurate at a certain position near the patient. The investigators will do this
      by having participants fill out a survey about the quality of the Cardiopulmonary
      Resuscitation in several recorded resuscitation scenarios.
Pediatric cardiac arrest leads to significant productive years lost, and has a huge emotional
      impact on families and caregivers. High quality CPR is the most important predictor for
      outcome in cardiac arrest. Human visual observation is commonly used and important to
      evaluate CPR quality. Interestingly, the accuracy of healthcare providers' visual assessment
      of CPR quality is unknown.

      Primary Objective: To determine the accuracy of visual CPR assessment. Secondary Objective:
      1) To identify the optimal position relative to the patient for accurate CPR assessment. 2)
      To determine health care practitioners' accuracy in identifying CPR errors.

      Methods: We will videotape both good quality CPR and poor quality CPR in a simulated
      resuscitation. We will record 4 videos, one depicting high quality CPR, and 3 depicting the
      most common mistakes made when performing chest compressions, and these will be videotaped
      from the foot, head and side of the patient. Pediatric acute care professionals will be
      recruited to watch a randomized set of all 12 video clips, and fill out a brief and simple
      questionnaire on their assessment of the quality of the CPR being performed.

      To assess the accuracy of the CPR quality, quantitative data on the quality of the CPR being
      performed during each of the 4 videotaped events will be captured and confirmed using a
      Laerdal CPRcard© (depth and rate) and the paediatric simulator SimJr© (recoil).

      Operative definitions:

        1. Chest compression depth: defined as the maximum posterior deflection of the sternum
           prior to chest recoil. In order to be accurate a non-compressible surface must be
           beneath the patient. It is considered shallow is it is less than 50 mm and deep is
           greater than 60mm. Adequate chest compression depth is defined as being between 50-60
           mm.

        2. Chest compression rate: defined as the frequency of chest compressions per minute. It is
           considered slow if less than 100 chest compressions are performed per minute, and too
           fast if greater than 120 compressions are performed per minute. This rate will be
           calculated during 60 seconds intervals while chest compressions are provided. Adequate
           chest compression rate is defined as being between 100 and 120 compressions per minute.

        3. Incomplete release of compressions/Recoil: defined as "leaning" phenomenon in which
           force is not completely removed during compressions. This is best reported by a simple
           binary measure: complete or incomplete (>2500g residual leaning force). Adequate recoil
           will be complete chest wall recoil.

      Primary Outcome Measures: Proportion of healthcare providers who are accurate in their visual
      assessment of CPR quality.

      Secondary Outcome Measures:

        1. Proportion of healthcare practitioners who accurately report CPR quality from position
           in relation to the patient (head, side and foot of bed).

        2. Proportion of healthcare practitioners accurately identifying CPR errors (rate, depth,
           recoil).
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Investigator)
measure: Proportion of healthcare providers who are accurate in their visual assessment of CPR quality.
time frame: Data is anticipated to be presented 4 months after it is collected.
measure: Proportion of healthcare practitioners who accurately report CPR quality from position in relation to the patient (head, side and foot of bed).
time frame: Data is anticipated to be presented 4 months after data is collected.
measure: Proportion of healthcare practitioners accurately identifying CPR errors (rate, depth, recoil).
time frame: Data is anticipated to be presented about 4 months after it is collected.
arm group label: Pediatric Acute Care Professionals
arm group type: Experimental
description: Individuals must work in ER or ICU setting regularly or rotate through this setting with up to date BLS/PALS/ACLS certification. The participants will be required to rate the CPR based on accuracy for each video shown. The type of CPR error(s) shown to the individuals will be randomized.
intervention type: Behavioral
intervention name: The type of CPR error(s) shown to the individual
description: Participants will be randomly assigned 12 videos to watch and rate the CPR quality of each. Investigators will be blind to the identity of the participants.
arm group label: Pediatric Acute Care Professionals
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adam Cheng, MD, FRCPC
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
citation: Sutton R, Niles D, Nysaether J et al. Quantitative Analysis of CPR quality during in-hospital resuscitation of older children and adolescents. Pediatrics. 2009; 124 : 1930-8. Sutton R, Maltese M, Niles D et al. Quantitative analysis of chest compression interruption during in-hospital resuscitation of older children and adolescents. Resuscitation 2009; 80:1259-1263. Atkins DL et al. Epidemiology and Outcomes From Out-of-Hospital Cardiac Arrest in Children: The Resuscitation Outcomes Consortium Epistry-Cardiac Arrest. Circulation. 2009;119:1484-91. Atkins DL, Everson-Stewart S, Sears GK, Daya M, Osmond MH, Warden CR, Berg RA. Epidemiology and outcomes from out-of-hospital cardiac arrest in children: the Resuscitation Outcomes Consortium Epistry-Cardiac Arrest. Circulation. 2009;119:1484-1491.
responsible party type: Principal Investigator
investigator affiliation: KidSIM Simulation Program
investigator full name: Nicola Robertson
investigator title: KidSim Aspire Coordinator