NCT04440111

Brief Summary

A controlled clinical trial will be performed. School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza. One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year. The investigators think that the knowledge will be better in the group that receives two interventions.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 11, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

16 days

First QC Date

June 16, 2020

Last Update Submit

June 18, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • To evaluate the knowledge level of BLS after receiving one or two interventions

    A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015.

    3 hours

  • To compare test results obtained previous and after intervention.

    A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software.

    1 month

Study Arms (2)

Control group

ACTIVE COMPARATOR

One year basic life support training

Other: One year training

Experimental group

SHAM COMPARATOR

Two years basic life support training

Other: Two years training

Interventions

At first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice.

Also known as: One year basic life support training
Control group

At first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will repeat the same process.

Also known as: Two years basic life support training
Experimental group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children from 10 to 12 years old that are attending to the selected school at the moment of the intervention
  • Children with signed consent given by parents at the moment of the intervention

You may not qualify if:

  • Children not attending all the theorical and practical interventions
  • Children not completing all test.
  • Children with learning disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cristina Genzor Ríos

Zaragoza, 50009, Spain

Location

Related Publications (6)

  • Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.

  • Bottiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul 21. No abstract available.

  • Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.

  • Lukas RP, Van Aken H, Molhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.

  • Bohn A, Lukas RP, Breckwoldt J, Bottiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204.

  • Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 19, 2020

Study Start

February 11, 2020

Primary Completion

February 27, 2020

Study Completion

April 1, 2021

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations