Clinical trial NCT04152252: CPR Quality and Use of Feedback for OHCA
Official title: Cardio-Pulmonary-Resuscitation Quality in Out-of-Hospital Cardiac Arrest - Effect of Real-time Feedback and Post-event Debriefing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: OHCA
Feedback
CPR quality
Lead sponsor: Emergency Medical Services, Capital Region, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: TrygFonden, Denmark
name: St George's, University of London
name: Kingston University
First posted: 2019-11-05
Enrollment: 2989
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chest compression depth
timeFrame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
measure: Sustained return of spontaneous circulation (ROSC)
timeFrame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
measure: 30- day survival
timeFrame: 30 days from event
measure: Chest compression rate
timeFrame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
measure: Chest compression fraction
timeFrame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Copenhagen EMS
Study officials:
affiliation: Emergency Medical Services, Capital Region, Denmark
name: Rasmus Lyngby, BSc
role: PRINCIPAL_INVESTIGATOR
References: