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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Express Collaborative
ClinicalTrials.gov Identifier:
NCT02075450
First received: February 26, 2014
Last updated: August 18, 2015
Last verified: August 2015
  Purpose

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


Condition Intervention
Cardiac Arrest
Device: CPRcard
Other: Just in Time Video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Assessing and Improving the Quality of Cardiopulmonary Resuscitation (CPR) Delivered During Simulated Pediatric Cardiac Arrest Using a Novel Pediatric CPR Feedback Device

Resource links provided by NLM:


Further study details as provided by Express Collaborative:

Primary Outcome Measures:
  • Chest Compression Depth [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Chest Compression Rate [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • No Flow Fraction [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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.

  • Residual Leaning Force [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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

  • Frequency of Chest Compression Switches [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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.

  • Mean difference between perceived and actual quality of CPR [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    As calculated by perceived performance minus actual performance, for depth and rate

  • Accurate estimation of CPR quality [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    As calculated by the absolute difference of less than 10% between perceived and actual quality of CPR, for depth and rate

  • NASA TLX Score [ Time Frame: up to 6 month ] [ Designated as safety issue: No ]
    NASA TLX measures the perceived task load for healthcare providers. To be filled out by participants after each scenario


Enrollment: 324
Study Start Date: July 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CPRcard = CPR feedback device
Other: Just in Time Video
CPR Just in Time training video administered before the simulation case

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075450

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Connecticut
Yale University Hospital
New Haven, Connecticut, United States, 06510
United States, Illinois
Children's Memorial Hospital Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
John Hopkins Children's Hospital
Baltimore, Maryland, United States, 21287
United States, New York
Columbia University Hospital
New York, New York, United States, 10032
United States, Rhode Island
Hasbro Children's Hosptial
Providence, Rhode Island, United States, 02903
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Canada, Alberta
Alberta Children's Hosptial
Calgary, Alberta, Canada, T3B 6A8
Jon Duff
Edmonton, Alberta, Canada, T6G 2L9
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom, Bs2 8BJ
Sponsors and Collaborators
Express Collaborative
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Investigators
Study Chair: Vinay Nadkarni, MD Children's Hospital of Philadelphia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Express Collaborative
ClinicalTrials.gov Identifier: NCT02075450     History of Changes
Other Study ID Numbers: E-23697
Study First Received: February 26, 2014
Last Updated: August 18, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Express Collaborative:
Cardiac
Arrest
Simulation
Feedback

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 31, 2015