Cardiopulmonary ResuscitationNCT03204162
Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest
A study testing CPR Coaching in people with Cardiopulmonary Resuscitation, run by KidSIM Simulation Program at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- CPR Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Sep 2017to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not BLS certified
Trial locations and contacts
5 sites in 2 countries.
Nicola Peiris contact
5 sites in 2 countries
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Nancy Tofil, MD, ntofil@peds.uab.edu
Nancy Tofil, MD
Columbia University Hospital
New York, New York, 10032
David Kessler, MD, drkessler@gmail.com
David Kessler, MD
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Linda Brown, MD, lbrown8@lifespan.org
Linda Brown, MD
Canada2 sites
University of Calgary
Calgary, Alberta, T3B6A8
Adam Cheng, MD, chenger@me.com
Adam Cheng, MD
University of Alberta
Edmonton, Alberta, T6G2L9
Jon Duff, MD, jon.duff@ualberta.ca
Jon Duff, MD
About this study
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.
Read the 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.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- CPR Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR CoachingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Teams with no CPR Coach | No intervention | This will be a standardized Resuscitation team with no CPR Coach |
| Teams with CPR Coach | Experimental | This will be a standardized Resuscitation team where one member will be the CPR Coach and provide CPR Coaching to the team. Receives: Other: CPR Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPR Depth
Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm
Measured: During simulation scenario -Day 1
Secondary outcomes (7)
CPR Rate
Proportion of 1 minute epochs of CPR with rate of 100-120 beats per minute
Measured: During simulation scenario - Day 1
Chest Compression Fraction
Percentage of time that compressions are provided during pulselessness
Measured: During simulation scenario - Day 1
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
Measured: Data collected immediately following the simulation session - Day 1
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
Measured: Data collected immediately following the simulation session - Day 1
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
Measured: Data collected immediately following the simulation session -Day 1
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.
Measured: Day 1 (baseline performance)
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)
Measured: Day 1 (Baseline performance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Sep 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KidSIM Simulation Program
- Sponsor type
- Research network
- Collaborators
- KidSIM-ASPIRE
- Responsible party
- Sponsor
- Investigators
- Adam Cheng, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204162
- Sponsor's protocol ID
- REB15-2187
- Status last verified
- Jun 2017
- First submitted
- 25 Apr 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25531167Cheng 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.
PubMed 25433294
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Integration of CPR Feedback Technology With CPR Coaching for Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03204162
- Acronym / sponsor ID
- REB15-2187
- Conditions
- Cardiopulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- KidSIM Simulation ProgramResearch network
- Collaborators
- KidSIM-ASPIRE
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teams with no CPR Coach | No intervention | –This will be a standardized Resuscitation team with no CPR Coach |
| Teams with CPR Coach | Experimental | Other: CPR CoachingThis will be a standardized Resuscitation team where one member will be the CPR Coach and provide CPR Coaching to the team. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Not BLS certified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPR CoachingTeams 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. | Other | Teams with CPR Coach |
Primary outcome
CPR Depth
Time frame: During simulation scenario -Day 1
Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm
7 secondary outcomes
CPR Rate
Time frame: During simulation scenario - Day 1
Chest Compression Fraction
Time frame: During simulation scenario - Day 1
Perception of CPR Quality - Depth
Time frame: 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
Perception of CPR Quality - Chest compression fraction
Time frame: Data collected immediately following the simulation session -Day 1
Adherence to Pediatric Advanced Life Support Guidelines
Time frame: Day 1 (baseline performance)
Airway Management Performance
Time frame: Day 1 (Baseline performance)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Background: PubMed 25531167Cheng 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.
- Background: PubMed 25433294Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Peiris contact
Adam Cheng, MD principal investigator
University of Calgary
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPR Coaching in people with Cardiopulmonary Resuscitation, run by KidSIM Simulation Program at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Cheng, MD (403-955-2623, chenger@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPR Depth (time frame: During simulation scenario -Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204162, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.