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

Cardiopulmonary Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03204162
• Other study ID #: REB15-2187
• Status: Not yet recruiting
• Phase: N/A
• First received: April 25, 2017
• Last updated: June 28, 2017
• Start date: September 1, 2017
• Est. completion date: January 2019

Study information

• Verified date: June 2017
• Source: Express Collaborative
• Contact: Adam Cheng, MD
• Phone: 403-955-2623
• Email: chenger[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Resuscitation
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Columbia University Hospital	New York	New York
United States	Hasbro Children's Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Express Collaborative	KidSIM-ASPIRE

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPR Depth	Proportion of 1 minute epochs of CPR with depth of 5cm to 6cm	During simulation scenario -Day 1
Secondary	CPR Rate	Proportion of 1 minute epochs of CPR with rate of 100-120 beats per minute	During simulation scenario - Day 1
Secondary	Chest Compression Fraction	Percentage of time that compressions are provided during pulselessness	During simulation scenario - Day 1
Secondary	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	Data collected immediately following the simulation session - Day 1
Secondary	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	Data collected immediately following the simulation session - Day 1
Secondary	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	Data collected immediately following the simulation session -Day 1
Secondary	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.	Day 1 (baseline performance)
Secondary	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)	Day 1 (Baseline performance)