NCT04152252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,989

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

October 29, 2019

Last Update Submit

March 7, 2023

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

OHCAFeedbackCPR quality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Return of spontaneous circulation (ROSC)

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

  • Sustained return of spontaneous circulation (ROSC)

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

  • 30- day survival

    30 days from event

  • Chest compression rate

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

  • Chest compression fraction

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

Study Arms (3)

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

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 feedbackBehavioral: Post-event debriefing

Interventions

Real time feedbackOTHER

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 debriefingReal-time feedback
Post-event debriefingBEHAVIORAL

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.

Post-event debriefing

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • OHCA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen EMS

Ballerup Municipality, 2750, Denmark

Location

Related Publications (1)

  • Lyngby RM, Quinn T, Oelrich RM, Nikoletou D, Gregers MCT, Kjolbye JS, Ersboll AK, Folke F. Association of Real-Time Feedback and Cardiopulmonary-Resuscitation Quality Delivered by Ambulance Personnel for Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2023 Oct 17;12(20):e029457. doi: 10.1161/JAHA.123.029457. Epub 2023 Oct 13.

    PMID: 37830329DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Rasmus Lyngby, BSc

    Emergency Medical Services, Capital Region, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paramedic (BSc.)

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 5, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Danish legislation do not allow for sharing of individual patient data without patient consent

Locations

DK(1)