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CPR Quality and Use of Feedback for OHCA

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ClinicalTrials.gov Identifier: NCT04152252
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
TrygFonden, Denmark
St George's, University of London
Kingston University
Information provided by (Responsible Party):
Rasmus Meyer Lyngby, Emergency Medical Services, Capital Region, Denmark

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.

Condition or disease Intervention/treatment
Out-Of-Hospital Cardiac Arrest 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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardio-Pulmonary-Resuscitation Quality in Out-of-Hospital Cardiac Arrest - Effect of Real-time Feedback and Post-event Debriefing
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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

  2. 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 per minute.

  3. 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.


Secondary Outcome Measures :
  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

  2. Exposure to debriefing [ Time Frame: From the time of CPR attempt termination or handover at hospital to a new assignment is handed to the crew, up to 1 hour ]
    The total number of time the individual EMS professional has been exposed to the post-event debriefing procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients in OHCA in the Capital Region of Denmark who receive CPR for at least 2 minutes delivered by or under supervision of EMS professionals with the standard defibrillator attached.
Criteria

Inclusion Criteria:

OHCA

Exclusion Criteria:

No use of EMS defibrillator attached to patient during resuscitation attempt Less than 2 minutes of CPR with EMS defibrillator attached to patient OHCA with non-adult algorithm (Age 17 or younger) OHCA without involvement of the physician manned vehicle Patients who are subject to mechanical CPR from the time of device attachment Traumatic OHCA


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152252


Contacts
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Contact: Rasmus Lyngby, BSc. +4540766608 rasmus.meyer.lyngby@regionh.dk
Contact: Fredrik Folke, MD fredrik.folke@regionh.dk

Locations
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Denmark
Copenhagen EMS Recruiting
Ballerup, Denmark, 2750
Contact: Rasmus Lyngby, BSc.    +4540766608    rasmus.meyer.lyngby@regionh.dk   
Contact: Fredrik Folke, MD       fredrik.folke@regionh.dk   
Sponsors and Collaborators
Emergency Medical Services, Capital Region, Denmark
TrygFonden, Denmark
St George's, University of London
Kingston University

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Responsible Party: Rasmus Meyer Lyngby, Paramedic (BSc.), Emergency Medical Services, Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT04152252     History of Changes
Other Study ID Numbers: F-35103-02
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Danish legislation do not allow for sharing of individual patient data without patient consent

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rasmus Meyer Lyngby, Emergency Medical Services, Capital Region, Denmark:
OHCA
Feedback
CPR quality
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases