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

June 28, 2017 updated by: Express Collaborative

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Adam Cheng, MD
  • Phone Number: 403-955-2623
  • Email: chenger@me.com

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B6A8
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G2L9
        • University of Alberta
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • New York
      • New York, New York, United States, 10032
        • Columbia University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Teams with no CPR Coach
This will be a standardized Resuscitation team with no CPR Coach
Experimental: Teams with CPR Coach
This will be a standardized Resuscitation team where one member will be the CPR Coach and provide CPR Coaching to the team.
Other: CPR Coaching
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CPR Depth
Time Frame: During simulation scenario -Day 1
Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm
During simulation scenario -Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CPR Rate
Time Frame: During simulation scenario - Day 1
Proportion of 1 minute epochs of CPR with rate of 100-120 beats per minute
During simulation scenario - Day 1
Chest Compression Fraction
Time Frame: During simulation scenario - Day 1
Percentage of time that compressions are provided during pulselessness
During simulation scenario - Day 1
Perception of CPR Quality - Depth
Time Frame: Data collected immediately following the simulation session - Day 1
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
Data collected immediately following the simulation session - Day 1
Perception of CPR Quality - Rate
Time Frame: Data collected immediately following the simulation session - Day 1
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
Data collected immediately following the simulation session - Day 1
Perception of CPR Quality - Chest compression fraction
Time Frame: Data collected immediately following the simulation session -Day 1
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
Data collected immediately following the simulation session -Day 1
Adherence to Pediatric Advanced Life Support Guidelines
Time Frame: Day 1 (baseline performance)
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.
Day 1 (baseline performance)
Airway Management Performance
Time Frame: Day 1 (Baseline 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)
Day 1 (Baseline performance)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Express Collaborative

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KidSIM-ASPIRE

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam Cheng, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB15-2187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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