CPR Quality and Use of Feedback for OHCA

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152252
• Other study ID #: F-35103-02
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2023
• Source: Emergency Medical Services, Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2989
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen EMS	Ballerup

Sponsors (4)

Lead Sponsor	Collaborator
Emergency Medical Services, Capital Region, Denmark	Kingston University, St George's, University of London, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	30- day survival	Patient alive at day 30 from event	30 days from event
Secondary	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
Secondary	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