Trial record 11 of 33 for:    Open Studies | cardiopulmonary resuscitation

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Express Collaborative
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: June 24, 2014
Last verified: June 2014
  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


Estimated Enrollment: 530
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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

Contacts
Contact: Adam Cheng, MD 4039552633 adam.cheng@albertahealthservices.ca
Contact: Nicola Robertson nicola.robertson@albertahealthservices.ca

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Nacy Tofil, MD       ntofil@peds.uab.edu   
Contact: Dawn Taylor Peterson, Phd.       dawn.taylor-oeterson@chsys.org   
Principal Investigator: Nancy Tofil, MB         
United States, Connecticut
Yale University Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Stephanie Sudikoff, MD       stephanie.sudikoff@ynhh.org   
Contact: Kim Marohn, MD       kimberly.marohn@yale.edu   
Principal Investigator: Stephanie Sudikoff, MD         
United States, Illinois
Children's Memorial Hospital Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Adler, MD       m-adler@northwestern.edu   
Contact: Janet Flores       jaflores@childrensmemorial.org   
Principal Investigator: Mark Adler, MD         
United States, Maryland
John Hopkins Children's Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Besty Hynt, MD       ehunt@jhmi.edu   
Contact: Nnenna Chime       nchime@jhsph.edu   
Principal Investigator: Besty Hunt, MD         
United States, New York
Columbia University Hospital Recruiting
New York, New York, United States, 10032
Contact: David Kessler, MD       drkessler@gmail.com   
Contact: Kristin Powers       Kap2159@columbia.edu   
Principal Investigator: David Kessler, MD         
United States, Rhode Island
Hasbro Children's Hosptial Recruiting
Providence, Rhode Island, United States, 02903
Contact: Linda Brown, MD       lbrown8@lifespan.org   
Contact: Frank Overlay       fbhanji@hotmail.com   
Principal Investigator: Linda Brown, MD         
United States, Texas
Children's Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: John Zhong, MD       john.zhong@childrens.com   
Contact: Roxana Ploski       roxana.ploski@UTSouthwestern.edu   
Principal Investigator: John Zhong, MD         
Canada, Alberta
Alberta Children's Hosptial Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Adam Cheng, FCRC    403-629-9400    chenger@me.com   
Contact: Jenny Chatfield, BsCN       jenny.chatfield@albertahealthservices.ca   
Principal Investigator: Adam Cheng, FCRC         
Jon Duff Recruiting
Edmonton, Alberta, Canada, T6G 2L9
Contact: Jon Duff, MD       jon.duff@albertahealthservices.ca   
Contact: kirstin Balon, RN       Kirstin.balon@albertahealthservices.ca   
Principal Investigator: Jon Duff, MD         
Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Farhan Bhanji, MB       fbhanji@hotmail.com   
Contact: Jean Francis Trudel       jeanfrancois.trudel@videotron.ca   
Principal Investigator: Farhan Bhanji, MB         
United Kingdom
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, Bs2 8BJ
Contact: David Grant, MD       david.grant@nhs.net   
Principal Investigator: David Grant, MD         
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:
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: June 24, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Express Collaborative:
Cardiac
Arrest
Simulation
Feedback

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014