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Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest

Primary Purpose

Cardiopulmonary Resuscitation

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CPR Coaching
Sponsored by
KidSIM Simulation Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiopulmonary Resuscitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Team Members: (i) Pediatric healthcare providers: such as nurses, nurse practitioners, respiratory therapists and residents (pediatric, emergency medicine, anesthesia, family medicine); and (ii) Basic Life Support (BLS), Pediatric Advanced Life Support (PALS) or Advanced Cardiac Life Support (ACLS) certification within the past two years;
  • Team Leaders: (i) Residents (Year 3 or 4) in pediatrics, family medicine, anesthesia, or emergency medicine training programs or fellows in pediatric emergency medicine, pediatric critical care or pediatric anesthesia subspecialty training programs; (ii) Attending physicians from pediatric intensive care, pediatric emergency medicine, general pediatrics; and (iii) PALS certification in the past two years or are PALS

Exclusion Criteria:

  • Not BLS certified

Sites / Locations

  • University of Alabama at Birmingham
  • Columbia University Hospital
  • Hasbro Children's Hospital
  • University of Calgary
  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Teams with no CPR Coach

Teams with CPR Coach

Arm Description

This will be a standardized Resuscitation team with no CPR Coach

This will be a standardized Resuscitation team where one member will be the CPR Coach and provide CPR Coaching to the team.

Outcomes

Primary Outcome Measures

CPR Depth
Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm

Secondary Outcome Measures

CPR Rate
Proportion of 1 minute epochs of CPR with rate of 100-120 beats per minute
Chest Compression Fraction
Percentage of time that compressions are provided during pulselessness
Perception of CPR Quality - Depth
Perceived quality of CPR depth will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured quality of CPR depth from the defibrillator
Perception of CPR Quality - Rate
Perceived quality of CPR rate will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured quality of CPR rate from the defibrillator
Perception of CPR Quality - Chest compression fraction
Perceived chest compression fraction will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured chest compression fraction from the defibrillator
Adherence to Pediatric Advanced Life Support Guidelines
To assess clinical performance, the investigators will use a tool that assesses the team's performance during the simulated scenario. There will be no baseline performance measurement, and performance will be measured via retrospective video review after the simulation session is complete. Raters will be trained in the use of the Clinical Performance Tool (CPT). The tool scores items on a three point scale, with 0 = task not done, 1 = task done but not completely or 2 = task done correctly. The tool examines clinical performance specifically and not psychomotor performance. The CPT also accounts for tasks done in the incorrect sequence or done too late. This instrument has been found to produce valid data for clinical performance during PALS scenarios. For this current study, the version of this tool that will be used was modified slightly and validated in a previous multi centre trial carried out by this research team.
Airway Management Performance
In order to assess airway management, the investigators will measure time to successfully intubate the manikin during the simulated scenario. There will be no baseline measurement, but rather just a report of the time to intubation during the one cardiac arrest simulation scenario (as collected by retrospective video review)

Full Information

First Posted
April 25, 2017
Last Updated
June 28, 2017
Sponsor
KidSIM Simulation Program
Collaborators
KidSIM-ASPIRE
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1. Study Identification

Unique Protocol Identification Number
NCT03204162
Brief Title
Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest
Official Title
Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KidSIM Simulation Program
Collaborators
KidSIM-ASPIRE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There is significant data showing that the quality of CPR performed is quite poor. Recent studies have shown that when real-time visual corrective feedback is available to CPR providers, quality (compression depth and rate) improves. Pilot work at John's Hopkins Children's Hospital indicates that providing a CPR Coach whose role it is to provide real-time coaching during cardiac arrest, further improves the quality of CPR. This study will assess the impact of a CPR Coach for improving CPR quality and CPR perception in a team of healthcare providers during simulated CPA.
Detailed Description
Cardiopulmonary resuscitation (CPR) is provided for thousands of children with cardiopulmonary arrests (CPA) each year in North America. The quality of CPR directly impacts hemodynamics, survival, and neurologic outcome following cardiac arrest. Well-trained healthcare providers consistently fail to perform CPR within established Heart and Stroke Foundation of Canada (HSFC) resuscitation guidelines. The poor quality of healthcare provider CPR adversely affects survival outcomes and quality of life in cardiac arrest survivors. CPR feedback devices that provide real-time visual corrective feedback during CPA have become valuable tools to help to improve the overall quality of CPR. The cardiac arrest literature shows that although CPR feedback devices help to improve the overall quality of CPR, there is still substantial room for improvement. A recent multicenter study involving ten pediatric institutions led by the principal investigator of this project evaluated the impact of CPR feedback on CPR quality during simulated CPA5. This study demonstrated that the use of CPR feedback improved depth compliance by 15.4% and rate compliance by 40.1%. However, overall compliance with guidelines in the CPR feedback group was still under 40% for depth and under 75% for rate. Data collected by this research team suggests that a variety of factors may influence the effectiveness of real-time CPR feedback. CPR providers interviewed after a simulated cardiac arrest report that they often are distracted by other events while providing CPR, are unable to clearly see the device, or have difficulty interpreting the visual display on the CPR feedback device. Additionally, many providers' perception of CPR quality is inaccurate, with providers consistently overestimating the quality of CPR provided during simulated CPA, even when using CPR feedback. This suggests a need to improve provider perception of CPR and provider awareness of the CPR feedback device. To improve the quality of CPR the investigators propose the implementation of a standardized resuscitation team structure with a CPR coach. To date, there have been no studies describing the optimal team structure required for integration of CPR feedback defibrillators during CPA. In this study,the investigators propose the concept of a CPR coach, whose primary responsibility is to provide real-time coaching during cardiac arrest to improve the quality of CPR. Preliminary pilot work done in the intensive care unit at Johns Hopkins Children's Hospital suggests that use of a CPR coach improves the quality of CPR in comparison prior teams that functioned without a CPR coach. This study will assess the impact of a CPR Coach for improving CPR quality and CPR perception in a team of healthcare providers during simulated CPA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Resuscitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teams with no CPR Coach
Arm Type
No Intervention
Arm Description
This will be a standardized Resuscitation team with no CPR Coach
Arm Title
Teams with CPR Coach
Arm Type
Experimental
Arm Description
This will be a standardized Resuscitation team where one member will be the CPR Coach and provide CPR Coaching to the team.
Intervention Type
Other
Intervention Name(s)
CPR Coaching
Intervention Description
Teams in the experimental arm will have a member of their team assigned to be the CPR Coach. This person will provide CPR Coaching in the form of feedback in CPR quality (depth, rate) to the CPR providers as well as provide guidance on time for defibrillation, etc.
Primary Outcome Measure Information:
Title
CPR Depth
Description
Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm
Time Frame
During simulation scenario -Day 1
Secondary Outcome Measure Information:
Title
CPR Rate
Description
Proportion of 1 minute epochs of CPR with rate of 100-120 beats per minute
Time Frame
During simulation scenario - Day 1
Title
Chest Compression Fraction
Description
Percentage of time that compressions are provided during pulselessness
Time Frame
During simulation scenario - Day 1
Title
Perception of CPR Quality - Depth
Description
Perceived quality of CPR depth will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured quality of CPR depth from the defibrillator
Time Frame
Data collected immediately following the simulation session - Day 1
Title
Perception of CPR Quality - Rate
Description
Perceived quality of CPR rate will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured quality of CPR rate from the defibrillator
Time Frame
Data collected immediately following the simulation session - Day 1
Title
Perception of CPR Quality - Chest compression fraction
Description
Perceived chest compression fraction will be collected by survey following the simulated cardiac arrest event. Survey data will be compared with measured chest compression fraction from the defibrillator
Time Frame
Data collected immediately following the simulation session -Day 1
Title
Adherence to Pediatric Advanced Life Support Guidelines
Description
To assess clinical performance, the investigators will use a tool that assesses the team's performance during the simulated scenario. There will be no baseline performance measurement, and performance will be measured via retrospective video review after the simulation session is complete. Raters will be trained in the use of the Clinical Performance Tool (CPT). The tool scores items on a three point scale, with 0 = task not done, 1 = task done but not completely or 2 = task done correctly. The tool examines clinical performance specifically and not psychomotor performance. The CPT also accounts for tasks done in the incorrect sequence or done too late. This instrument has been found to produce valid data for clinical performance during PALS scenarios. For this current study, the version of this tool that will be used was modified slightly and validated in a previous multi centre trial carried out by this research team.
Time Frame
Day 1 (baseline performance)
Title
Airway Management Performance
Description
In order to assess airway management, the investigators will measure time to successfully intubate the manikin during the simulated scenario. There will be no baseline measurement, but rather just a report of the time to intubation during the one cardiac arrest simulation scenario (as collected by retrospective video review)
Time Frame
Day 1 (Baseline performance)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Team Members: (i) Pediatric healthcare providers: such as nurses, nurse practitioners, respiratory therapists and residents (pediatric, emergency medicine, anesthesia, family medicine); and (ii) Basic Life Support (BLS), Pediatric Advanced Life Support (PALS) or Advanced Cardiac Life Support (ACLS) certification within the past two years; Team Leaders: (i) Residents (Year 3 or 4) in pediatrics, family medicine, anesthesia, or emergency medicine training programs or fellows in pediatric emergency medicine, pediatric critical care or pediatric anesthesia subspecialty training programs; (ii) Attending physicians from pediatric intensive care, pediatric emergency medicine, general pediatrics; and (iii) PALS certification in the past two years or are PALS Exclusion Criteria: Not BLS certified
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Cheng, MD
Phone
403-955-2623
Email
chenger@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Peiris
Email
nicola.peiris@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Cheng, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Tofil, MD
Email
ntofil@peds.uab.edu
First Name & Middle Initial & Last Name & Degree
Nancy Tofil, MD
Facility Name
Columbia University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kessler, MD
Email
drkessler@gmail.com
First Name & Middle Initial & Last Name & Degree
David Kessler, MD
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Brown, MD
Email
lbrown8@lifespan.org
First Name & Middle Initial & Last Name & Degree
Linda Brown, MD
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B6A8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Cheng, MD
Email
chenger@me.com
First Name & Middle Initial & Last Name & Degree
Adam Cheng, MD
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2L9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Duff, MD
Email
jon.duff@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Jon Duff, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25531167
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.
Results Reference
background
PubMed Identifier
25433294
Citation
Cheng A, Overly F, Kessler D, Nadkarni VM, Lin Y, Doan Q, Duff JP, Tofil NM, Bhanji F, Adler M, Charnovich A, Hunt EA, Brown LL; International Network for Simulation-based Pediatric Innovation, Research, Education (INSPIRE) CPR Investigators. Perception of CPR quality: Influence of CPR feedback, Just-in-Time CPR training and provider role. Resuscitation. 2015 Feb;87:44-50. doi: 10.1016/j.resuscitation.2014.11.015. Epub 2014 Nov 26.
Results Reference
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Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest

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