NCT04353089

Brief Summary

Background Since 2001 when the Danish Cardiac Arrest Registry was first established several large-scale interventions aimed at the entire Danish population from all ages have been initiated. BLS courses have been made mandatory in all primary schools since January 2005, and when taking driver's license since October 2006. This has resulted in a steep increase in the number of Danish citizens attending a BLS course to approximately 3-4.5% of the entire population annually. Aim The aim of this study is to investigate the effect of the numerous population-based interventions to increase bystander basic life support (BLS) prior to arrival of Emergency Medical Services (EMS) to persons suffering from out-of-hospital cardiac arrest (OHCA). Further this study aim at identifying geographical areas with low frequency of Basic Life Support (BLS) education and low level of bystander initiated BLS to enable direction of further educational efforts in the future to increase survival. Methods By coupling the geographical coordinates of the BLS course certificates with the GPS coordinates of cardiac arrests, the effects of BLS courses on bystander CPR rates and survival can be investigated. In collaboration with researchers from Aalborg University Hospital, the entire Danish geography have been divided into digital squares of 100x100m and combined with sociodemographic data. This data will be coupled with national administrative parish of Denmark comprising some 2201 geographical units of approximately equal size. This geographic model has been combined with data from the Danish Cardiac Arrest Registry, the National Danish Patient registry and the Central Person Registry. The current study has access to the geodata of the GPS coordinates of Danish citizens who have attained a BLS course certificate between 2016 and 2019. By combining the two datasets in national administrative parish's of Denmark, the investigators are able to calculate the correlation between BLS course certificates, the rate of bystander CPR and survival of OHCA. Further, the investigators are able to pinpoint geographic areas where improvements of the BLS education level and bystander initiated BLS rates can be made. To involve laypersons in the current study, focus group interviews consisting of BLS course participants will be performed to explore the views of the attending laypersons on the project and revise accordingly. Expected outcome To identify geographical association between bystander CPR prior to EMS arrival and BLS training. A verified account of number of BLS certificates issued annually and geographical visual map of first aid certificates. Finally, it is a goal to be able to identify areas with which to start with better education. That is, areas where there is low frequency of courses and low frequency of bystanders initiated BLS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

January 30, 2020

Last Update Submit

July 31, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Bystander initiated CPR rate

    Rate of OHCA were bystander have initiated CPR prior to arrival of EMS

    1-2 years after course

  • 30-day Survival

    Survival will be defined as ROSC at the time of hospital admission. Further the investigators will include rates for 30-day survival derived with data from the National Patient Registry.

    Up to 3 weeks

  • Return-of-spontaneous-circulation (ROSC)

    ROSC will be defined as cases achieving ROSC anytime between recognition of the event and termination (defined as either hospital admission og declaration of death by EMS-personnel).

    Up to 3 weeks

  • State at hospital admission

    Defined as the case state on arrival at the hospital as either; ROSC or ongoing CPR.

    1 year

Study Arms (2)

Basic Life Support Participants

All persons attending certified Basic Life Support Courses in Denmark from 2016 to 2019

OHCA

Out-of-hospital cardiac arrest victims in Denmark from mid 2016 til mid 2019

Other: Basic life support courses

Interventions

4 hours certified basic life support courses

OHCA

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All danish citizens whom participated in a certified basic life support course between 2016 and 2019.

You may qualify if:

  • All danish citizens, with a verified personal identification number, whom participated in a certified basic life support course between 2016 and 2019.

You may not qualify if:

  • Basic life support course participants with in-complete/faulty registered personal identification number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Emergency Medical Services

Copenhagen, 2750, Denmark

Location

Related Publications (11)

  • Dansk Hjertestopsregister [Internet/in Danish]. [cited 2019 Nov 06]; Available from: http://hjertestopregister.dk/wp-content/uploads/2019/11/Dansk-Hjertestopregister-2018.pdf

    BACKGROUND
  • Wissenberg M, Lippert FK, Folke F, Weeke P, Hansen CM, Christensen EF, Jans H, Hansen PA, Lang-Jensen T, Olesen JB, Lindhardsen J, Fosbol EL, Nielsen SL, Gislason GH, Kober L, Torp-Pedersen C. Association of national initiatives to improve cardiac arrest management with rates of bystander intervention and patient survival after out-of-hospital cardiac arrest. JAMA. 2013 Oct 2;310(13):1377-84. doi: 10.1001/jama.2013.278483.

    PMID: 24084923BACKGROUND
  • Hansen SM, Hansen CM, Folke F, Rajan S, Kragholm K, Ejlskov L, Gislason G, Kober L, Gerds TA, Hjortshoj S, Lippert F, Torp-Pedersen C, Wissenberg M. Bystander Defibrillation for Out-of-Hospital Cardiac Arrest in Public vs Residential Locations. JAMA Cardiol. 2017 May 1;2(5):507-514. doi: 10.1001/jamacardio.2017.0008.

    PMID: 28297003BACKGROUND
  • Kragholm K, Wissenberg M, Mortensen RN, Hansen SM, Malta Hansen C, Thorsteinsson K, Rajan S, Lippert F, Folke F, Gislason G, Kober L, Fonager K, Jensen SE, Gerds TA, Torp-Pedersen C, Rasmussen BS. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2017 May 4;376(18):1737-1747. doi: 10.1056/NEJMoa1601891.

    PMID: 28467879BACKGROUND
  • Hansen CM, Lippert FK, Wissenberg M, Weeke P, Zinckernagel L, Ruwald MH, Karlsson L, Gislason GH, Nielsen SL, Kober L, Torp-Pedersen C, Folke F. Temporal trends in coverage of historical cardiac arrests using a volunteer-based network of automated external defibrillators accessible to laypersons and emergency dispatch centers. Circulation. 2014 Nov 18;130(21):1859-67. doi: 10.1161/CIRCULATIONAHA.114.008850. Epub 2014 Oct 1.

    PMID: 25274002BACKGROUND
  • Malta Hansen C, Zinckernagel L, Ersboll AK, Tjornhoj-Thomsen T, Wissenberg M, Lippert FK, Weeke P, Gislason GH, Kober L, Torp-Pedersen C, Folke F. Cardiopulmonary Resuscitation Training in Schools Following 8 Years of Mandating Legislation in Denmark: A Nationwide Survey. J Am Heart Assoc. 2017 Mar 14;6(3):e004128. doi: 10.1161/JAHA.116.004128.

    PMID: 28292745BACKGROUND
  • TrygFonden [Internet/in Danish]. [cited 2019 Nov 06]; Available from: https://genoplivning.dk/nyt-studie-4-5-danskere-har-vaeret-paa-foerstehjaelpskursus/

    BACKGROUND
  • Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.

    PMID: 26477420BACKGROUND
  • Karam N, Narayanan K, Bougouin W, Benameur N, Beganton F, Jost D, Lamhaut L, Perier MC, Cariou A, Celermajer DS, Marijon E, Jouven X. Major regional differences in Automated External Defibrillator placement and Basic Life Support training in France: Further needs for coordinated implementation. Resuscitation. 2017 Sep;118:49-54. doi: 10.1016/j.resuscitation.2017.07.002. Epub 2017 Jul 5.

    PMID: 28689047BACKGROUND
  • Karlsson L, Malta Hansen C, Wissenberg M, Moller Hansen S, Lippert FK, Rajan S, Kragholm K, Moller SG, Bach Sondergaard K, Gislason GH, Torp-Pedersen C, Folke F. Automated external defibrillator accessibility is crucial for bystander defibrillation and survival: A registry-based study. Resuscitation. 2019 Mar;136:30-37. doi: 10.1016/j.resuscitation.2019.01.014. Epub 2019 Jan 22.

    PMID: 30682401BACKGROUND
  • Sondergaard KB, Hansen SM, Pallisgaard JL, Gerds TA, Wissenberg M, Karlsson L, Lippert FK, Gislason GH, Torp-Pedersen C, Folke F. Out-of-hospital cardiac arrest: Probability of bystander defibrillation relative to distance to nearest automated external defibrillator. Resuscitation. 2018 Mar;124:138-144. doi: 10.1016/j.resuscitation.2017.11.067. Epub 2017 Dec 5.

    PMID: 29217395BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Freddy K Lippert, MD, Ass. Professor

    Copenhagen Emergency Medical Services

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

April 20, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2022

Study Completion

September 1, 2022

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations