NCT02075450

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

3 years

First QC Date

February 26, 2014

Last Update Submit

August 18, 2015

Conditions

Keywords

CardiacArrestSimulationFeedback

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Chest Compression Rate

    up to 6 months

Other Outcomes (6)

  • No Flow Fraction

    up to 6 months

  • Residual Leaning Force

    up to 6 months

  • Frequency of Chest Compression Switches

    up to 6 months

  • +3 more other outcomes

Study Arms (4)

Arm 1

NO INTERVENTION

Practice CPRcard lights not visible, Practice Just in Time Video - not provided to study participants, CPRcard lights not visible during study scenario

Arm 2

EXPERIMENTAL

Practice CPRcard light- not visible, Practice CPR Just in Time Video- not provided, CPRcard light visible during study scenario.

Device: CPRcard

Arm 3

EXPERIMENTAL

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

Arm # 4

EXPERIMENTAL

Practice CPRcard visible and the study participants watch the Just in Time Video,CPRcard light visible during study scenario

Device: CPRcardOther: Just in Time Video

Interventions

CPRcardDEVICE

CPR Card in place during chest compressions to provide immediate visual feedback.

Also known as: CPRcard = CPR feedback device
Arm # 4Arm 2

CPR Just in Time training video administered before the simulation case

Arm # 4Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Yale University Hospital

New Haven, Connecticut, 06510, United States

Location

Children's Memorial Hospital Chicago

Chicago, Illinois, 60611, United States

Location

John Hopkins Children's Hospital

Baltimore, Maryland, 21287, United States

Location

Columbia University Hospital

New York, New York, 10032, United States

Location

Hasbro Children's Hosptial

Providence, Rhode Island, 02903, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Alberta Children's Hosptial

Calgary, Alberta, T3B 6A8, Canada

Location

Jon Duff

Edmonton, Alberta, T6G 2L9, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Bristol Royal Hospital for Children

Bristol, Bristol, Bs2 8BJ, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 19733427BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Vinay Nadkarni, MD

    Children's Hospital of Philadelphia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 3, 2014

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations