CPR Quality and Use of Feedback for OHCA

Cardio-Pulmonary-Resuscitation Quality in Out-of-Hospital Cardiac Arrest - Effect of Real-time Feedback and Post-event Debriefing

The purpose of this study is to investigate the quality of cardio-pulmonary resuscitation(CPR) delivered by EMS professionals and whether this quality can be improved by implementing real-time feedback during the event and an oral post-event debriefing procedure based on the actual event performance data.

Study Overview

• Status: Active, not recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Other: Real time feedback; Behavioral: Post-event debriefing

Detailed Description

The aim of this study is to investigate whether CPR quality can be improved by implementing real-time feedback and immediate oral structured post-event debriefing in out-of-hospital cardiac arrest (OHCA).

The objectives of this study is to assess the current quality of CPR delivered by emergency medical services (EMS) during OHCA events in the Capital Region of Denmark. Furthermore, to investigate if CPR quality can be improved by applying real-time feedback during OHCA resuscitation attempts and to investigate if structured oral post-event debriefing delivered immediately after a resuscitation attempt and based on data from the defibrillator can further improve CPR quality

The hypothesis of this study is that adding real-time and post event feedback can improve the compression rate, compression depth, overall CPR hands-on time (CPR fraction), and recoil with at least 15% in total for both interventions.

Using a prospective study design data is retrieved from the standard defibrillator (ZOLL X series) through ZOLL RescueNet® Case Review (software for post-event review, analysis, and debriefing) from ZOLL Medical Corporation, Massachusetts, United States of America.

The study consists of three consecutive phases. Phase one with no feedback / debriefing available for EMS. Phase two with real-time feedback during the event and phase three which adds post-event debriefing to real-time feedback. We expect to be able to include at least 500 cases in each phase.

• Study Type: Observational
• Enrollment (Actual): 2989

Contacts and Locations

Study Locations

• Denmark
  • Ballerup, Denmark, 2750
    • Copenhagen EMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients in OHCA in the Capital Region of Denmark who receive CPR by or under supervision of EMS professionals with the standard EMS defibrillator attached.

Description

Inclusion Criteria:

OHCA

Exclusion Criteria:

No use of EMS defibrillator attached to patient during resuscitation attempt Patients < 18 years of age OHCA without involvement of the physician manned vehicle Patients who are subject to mechanical CPR from the time of device attachment Traumatic OHCA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Baseline; No CPR feedback during CPR
Real-time feedback; Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.	Other: Real time feedback; Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.
Post-event debriefing; Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes.	Other: Real time feedback; Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.; Behavioral: Post-event debriefing; Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest compression depth	Chest compression depth is defined as the maximum posterior deflection of the sternum prior to chest recoil. Measured in centimeters and as percentage of compressions within the recommended 5 to 6 cm	During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of spontaneous circulation (ROSC)	The return of a spontaneous pulse prior to handover at hospital measured as events	During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Sustained return of spontaneous circulation (ROSC)	The return of a spontaneous pulse at hospital handover measured as events	During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
30- day survival	Patient alive at day 30 from event	30 days from event
Chest compression rate	Chest compression rate is defined as the frequency of chest compressions during compression series. Measured in number compressions per minute (cpm) and percentage of delivered compressions within the recommended rate of 100-120 cpm	During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Chest compression fraction	Chest compression fraction is defined as the time with chest compressions starting from the first therapeutic event to the end of the episode. An episode is the time without presence of a spontaneous patient pulse. Measured in percentage.	During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

Collaborators and Investigators

• Sponsor: Emergency Medical Services, Capital Region, Denmark
• Collaborators: TrygFonden, Denmark; St George's, University of London; Kingston University
• Investigators: Principal Investigator: Rasmus Lyngby, BSc, Emergency Medical Services, Capital Region, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Feedback; OHCA; CPR quality
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: F-35103-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Danish legislation do not allow for sharing of individual patient data without patient consent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No