Improving the Quality of Cardiopulmonary Resuscitation (CPR) During Pediatric Cardiac Arrest (QCPR)

August 18, 2015 updated by: Express Collaborative

Assessing and Improving the Quality of Cardiopulmonary Resuscitation (CPR) Delivered During Simulated Pediatric Cardiac Arrest Using a Novel Pediatric CPR Feedback Device

Our project aims to improve the delivery and assessment of cardiopulmonary resuscitation (CPR) during pediatric cardiac arrest by introducing 2 novel approaches: 1. We will evaluate the effectiveness of a novel, credit card sized, and highly affordable "nano-card" CPR visual feedback device to improve compliance with HSFC CPR guidelines when used during simulated pediatric cardiac arrest; 2. We will also develop and study a novel, "Just-in-Time" (JIT) CPR training video, integrating proven educational methods (video-based lecture, expert modeling, practice-while-watching), and use the CPR visual feedback device to provide real-time coaching.

We hypothesize that:

H1: The use of a CPR visual feedback device will improve compliance with current HSFC CPR and resuscitation guidelines during a simulated pediatric in-hospital cardiac arrest scenario compared with standard CPR with no visual feedback.

H2: A JIT CPR Training Video, viewed by healthcare providers 2-4 weeks prior to the resuscitation event, will improve compliance with current HSFC CPR and resuscitation guidelines during simulated pediatric cardiac arrest compared with those healthcare providers with no prior exposure to the JIT CPR Training Video.

H3: That there is poor correlation between providers' perception of CPR quality and actual measured CPR quality H4: That task load varies depending on provider role and type of clinical scenario

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1 - To evaluate the effectiveness of a CPR visual feedback device to improve compliance with current Heart and Stork Foundation of Canada (HSFC) CPR and resuscitation guidelines during simulated pediatric cardiac arrest for a team of healthcare providers.

Aim 2 - To evaluate the effectiveness of a "Just in Time" CPR Training Video to improve compliance with current HSFC CPR and resuscitation guidelines during simulated pediatric cardiac arrest for a team of healthcare providers.

Aim 3 - To determine if there is a synergistic effect when adding Just in Time CPR Training Video with the use of the CPR visual feedback device to improve compliance with current HSFC CPR and resuscitation guidelines during a simulated pediatric cardiac arrest scenario.

Aim 4 - To determine the degree to which provider's perception of CPR quality matches actual quality of CPR

Aim 5 - To describe the task load of healthcare providers in sepsis and cardiac arrest scenarios

Participants will be recruited from ten pediatric tertiary care centers in Canada, the United States, and the United Kingdom using the methodology already piloted and studied in our existing EXPRESS investigators collaborative. Participants recruited to participate in the study will be asked to perform as members of a pediatric resuscitation team. Each team of healthcare providers will be randomized into one of four study arms. In study arm 1, resuscitation teams will participate in a simulated pediatric cardiac arrest scenario, and provide standard CPR without prior JIT training and blinded to any feedback from the CPR card during the scenario. Instead, the CPR card will be placed on the chest during compressions to collect real-time data, but the feedback lights on the card will be covered by black tape and thus, not visible to the members of the resuscitation team. In study arm 2, resuscitation teams will participate in the same scenario without prior JIT training, but provide chest compressions with the CPR card placed on the chest (and providing visual feedback) during compressions. In study arm 3, participants will be given a CPR card and asked to view the JIT training video. Following practice, they will be asked to participate in the simulated cardiac arrest scenario, and provide standard CPR without feedback from the CPR card. As in study arm 1, the CPR card will still be placed on the chest, but the feedback lights will be covered and not visible to the resuscitation team members. Finally, participants in study arm 4 will received JIT training prior to the simulated scenario, and have the CPR card in place during chest compressions to provide immediate visual feedback.

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hosptial
      • Edmonton, Alberta, Canada, T6G 2L9
        • Jon Duff
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Children's Memorial Hospital Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Children's Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hosptial
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center of Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Team Member: Pediatric healthcare providers, such as nurses, nurse practitioners, and residents (pediatric emergency medicine, anesthesia, family medicine)
  • Team Member: No prior experience with CPR feedback devices
  • Team Member: Basic Life Support, Pediatric Advanced Life Support or Advanced Cardiac Life Support certifications within the past two years
  • Team Leader: Residents (Year 2,3, or 4) in pediatrics, family medicine, anesthesia, emergency medicine training programs
  • Team Leader: fellows in pediatric emergency medicine, pediatric critical care or pediatric anesthesia sub specialty training programs, attending in-patient pediatricians.
  • Team Leader: No prior experience with CPR feedback devices
  • Team Leader: Pediatric Advanced Life Support in the past 2 years or are Pediatric Advanced Life Support instructors

Exclusion Criteria:

  • Team Member and Leader: Previous experience using, teaching with, or learning with a CPR feedback device
  • Team Member and Leader: No Basic Life Support, Pediatric Advance Life Support or Adult Cardiac Life Support Certification

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm 1
Practice CPRcard lights not visible, Practice Just in Time Video - not provided to study participants, CPRcard lights not visible during study scenario
Experimental: Arm 2
Practice CPRcard light- not visible, Practice CPR Just in Time Video- not provided, CPRcard light visible during study scenario.
Device: CPRcard
CPR Card in place during chest compressions to provide immediate visual feedback.
Other Names:
  • CPRcard = CPR feedback device
Experimental: Arm 3
Practice CPRcard light- visible, Practice Just in Time Video- watched by study participant, CPRcard light- not visible during study scenario.
Other: Just in Time Video
CPR Just in Time training video administered before the simulation case
Experimental: Arm # 4
Practice CPRcard visible and the study participants watch the Just in Time Video,CPRcard light visible during study scenario
Device: CPRcard
CPR Card in place during chest compressions to provide immediate visual feedback.
Other Names:
  • CPRcard = CPR feedback device
Other: Just in Time Video
CPR Just in Time training video administered before the simulation case

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest Compression Depth
Time Frame: up to 6 months
Chest compression depth is considered shallow if <40 mm and deep if >49.99 mm. The proportion of Chest Compression with depth between 40 and 49.99 mm will be reported.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest Compression Rate
Time Frame: up to 6 months
Chest compression rates will be calculated for the entire episode. The proportion of time spent doing compressions between 90-110 compressions/min will be reported.
up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
No Flow Fraction
Time Frame: up to 6 months
No flow time (time during cardiac arrest without chest compression delivery) will be calculated as the total scenario time minus the time with no chest compression delivery. No flow fraction (no flow fraction: proportion of cardiac arrest time without chest compression delivery) will be calculated as the no flow time divided by the total arrest time. In accordance with previous pediatric and adult CPR studies, pauses in chest compression delivery are defined as period of interruptions > 1.5 seconds.
up to 6 months
Residual Leaning Force
Time Frame: up to 6 months
Residual leaning force (grams) of delivered chest compression will be captured. The proportion of chest compression with excessive residual leaning force (>2500 grams) will be reported
up to 6 months
Frequency of Chest Compression Switches
Time Frame: up to 6 months
The number of chest compression provider switches will be recorded as the number of times there is a change in chest compression provider. A provider can be counted more than once if, in the interim, another provider has preformed chest compression of more than 1 minute before the same provider resumes compressions.
up to 6 months
Mean difference between perceived and actual quality of CPR
Time Frame: up to 6 months
As calculated by perceived performance minus actual performance, for depth and rate
up to 6 months
Accurate estimation of CPR quality
Time Frame: up to 6 months
As calculated by the absolute difference of less than 10% between perceived and actual quality of CPR, for depth and rate
up to 6 months
NASA TLX Score
Time Frame: up to 6 month
NASA TLX measures the perceived task load for healthcare providers. To be filled out by participants after each scenario
up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Express Collaborative

Collaborators

Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-23697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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