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Completed

NCT Number: NCT04152252

CPR Quality and Use of Feedback for OHCA

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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen EMS

Ballerup Municipality, 2750, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real time feedback

Other

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

Behavioral

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.

Primary outcomes

  1. Chest compression depth

    Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

    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

Secondary outcomes

  1. Return of spontaneous circulation (ROSC)

    Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

    The return of a spontaneous pulse prior to handover at hospital measured as events

  2. Sustained return of spontaneous circulation (ROSC)

    Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

    The return of a spontaneous pulse at hospital handover measured as events

  3. 30- day survival

    Time frame: 30 days from event

    Patient alive at day 30 from event

  4. Chest compression rate

    Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

    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

  5. Chest compression fraction

    Time frame: During cardiopulmonary resuscitation performed by emergency medical services, up to 4 hours

    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.

Sponsors and collaborators

Lead sponsor

Emergency Medical Services, Capital Region, Denmark

Other Gov

Collaborators

  • Kingston University
  • St George's, University of London
  • TrygFonden, Denmark

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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