Clinical trial NCT02075450: Improving the Quality of Cardiopulmonary Resuscitation (CPR) During Pediatric Cardiac Arrest
Official title: Assessing and Improving the Quality of Cardiopulmonary Resuscitation (CPR) Delivered During Simulated Pediatric Cardiac Arrest Using a Novel Pediatric CPR Feedback Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac
Arrest
Simulation
Feedback
Lead sponsor: KidSIM Simulation Program
Sponsor class: NETWORK
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
First posted: 2014-03-03
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: 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

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 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

Primary outcomes:
measure: Chest Compression Depth
timeFrame: up to 6 months
Secondary outcomes:
measure: Chest Compression Rate
timeFrame: up to 6 months
Other outcomes:
measure: No Flow Fraction
timeFrame: up to 6 months
measure: Residual Leaning Force
timeFrame: up to 6 months
measure: Frequency of Chest Compression Switches
timeFrame: up to 6 months
measure: Mean difference between perceived and actual quality of CPR
timeFrame: up to 6 months
measure: Accurate estimation of CPR quality
timeFrame: up to 6 months
measure: NASA TLX Score
timeFrame: up to 6 month
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Haven
country: United States
facility: Yale University Hospital
state: Connecticut
city: Chicago
country: United States
facility: Children's Memorial Hospital Chicago
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Children's Hospital
state: Maryland
city: New York
country: United States
facility: Columbia University Hospital
state: New York
city: Providence
country: United States
facility: Hasbro Children's Hosptial
state: Rhode Island
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Calgary
country: Canada
facility: Alberta Children's Hosptial
state: Alberta
city: Edmonton
country: Canada
facility: Jon Duff
state: Alberta
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vinay Nadkarni, MD
role: STUDY_CHAIR
References:
citation: Sutton RM, Maltese MR, Niles D, French B, Nishisaki A, Arbogast KB, Donoghue A, Berg RA, Helfaer MA, Nadkarni V. Quantitative analysis of chest compression interruptions during in-hospital resuscitation of older children and adolescents. Resuscitation. 2009 Nov;80(11):1259-63. doi: 10.1016/j.resuscitation.2009.08.009. Epub 2009 Sep 4.
citation: Cheng A, Hunt EA, Grant D, Lin Y, Grant V, Duff JP, White ML, Peterson DT, Zhong J, Gottesman R, Sudikoff S, Doan Q, Nadkarni VM, Brown L, Overly F, Bank I, Bhanji F, Kessler D, Tofil N, Davidson J, Adler M, Bragg A, Marohn K, Robertson N, Duval-Arnould J, Wong H, Donoghue A, Chatfield J, Chime N; International Network for Simulation-based Pediatric Innovation, Research, and Education CPR Investigators. Variability in quality of chest compressions provided during simulated cardiac arrest across nine pediatric institutions. Resuscitation. 2015 Dec;97:13-9. doi: 10.1016/j.resuscitation.2015.08.024. Epub 2015 Sep 28.
citation: Cheng A, Brown LL, Duff JP, Davidson J, Overly F, Tofil NM, Peterson DT, White ML, Bhanji F, Bank I, Gottesman R, Adler M, Zhong J, Grant V, Grant DJ, Sudikoff SN, Marohn K, Charnovich A, Hunt EA, Kessler DO, Wong H, Robertson N, Lin Y, Doan Q, Duval-Arnould JM, Nadkarni VM; International Network for Simulation-Based Pediatric Innovation, Research, & Education (INSPIRE) CPR Investigators. Improving cardiopulmonary resuscitation with a CPR feedback device and refresher simulations (CPR CARES Study): a randomized clinical trial. JAMA Pediatr. 2015 Feb;169(2):137-44. doi: 10.1001/jamapediatrics.2014.2616.