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

Cardiac Arrest Clinical Trial

— QCPR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075450
• Other study ID #: E-23697
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: August 18, 2015
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Express Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• CPRcard
CPR Card in place during chest compressions to provide immediate visual feedback.

Other:
• Just in Time Video
CPR Just in Time training video administered before the simulation case

Locations

Country	Name	City	State
Canada	Alberta Children's Hosptial	Calgary	Alberta
Canada	Jon Duff	Edmonton	Alberta
Canada	Montreal Children's Hospital	Montreal	Quebec
United Kingdom	Bristol Royal Hospital for Children	Bristol
United States	John Hopkins Children's Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Children's Memorial Hospital Chicago	Chicago	Illinois
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	Yale University Hospital	New Haven	Connecticut
United States	Columbia University Hospital	New York	New York
United States	Hasbro Children's Hosptial	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Express Collaborative	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	No Flow Fraction	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	No
Other	Residual Leaning Force	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	No
Other	Frequency of Chest Compression Switches	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	No
Other	Mean difference between perceived and actual quality of CPR	As calculated by perceived performance minus actual performance, for depth and rate	up to 6 months	No
Other	Accurate estimation of CPR quality	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	No
Other	NASA TLX Score	NASA TLX measures the perceived task load for healthcare providers. To be filled out by participants after each scenario	up to 6 month	No
Primary	Chest Compression Depth	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	No
Secondary	Chest Compression Rate	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	No