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Basic Life Support by Children

Primary Purpose

Cardiopulmonary Arrest With Successful Resuscitation, Child, Only

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
One year training
Two years training
Sponsored by
Cristina Genzor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiopulmonary Arrest With Successful Resuscitation

Eligibility Criteria

10 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Cristina Genzor Ríos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Control group

Experimental group

Arm Description

One year basic life support training

Two years basic life support training

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
June 18, 2020
Sponsor
Cristina Genzor
Collaborators
Hospital Miguel Servet
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1. Study Identification

Unique Protocol Identification Number
NCT04440111
Brief Title
Basic Life Support by Children
Official Title
Teaching Children Basic Life Support: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Genzor
Collaborators
Hospital Miguel Servet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A controlled clinical trial will be performed. 72 participants between 10 and 11 years old will be selected and randomized to participate. Control group and experimental group will enrolled 36 participants each one. Control group will receive BLS training once. Experimental group will receive BLS training in two consecutive years. Previous and after training a test will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest With Successful Resuscitation, Child, Only

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
One year basic life support training
Arm Title
Experimental group
Arm Type
Sham Comparator
Arm Description
Two years basic life support training
Intervention Type
Other
Intervention Name(s)
One year training
Other Intervention Name(s)
One year basic life support training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Two years training
Other Intervention Name(s)
Two years basic life support training
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the knowledge level of BLS after receiving one or two interventions
Description
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.
Time Frame
3 hours
Title
To compare test results obtained previous and after intervention.
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Children not attending all the theorical and practical interventions Children not completing all test. Children with learning disabilities
Facility Information:
Facility Name
Cristina Genzor Ríos
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30098386
Citation
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.
Results Reference
result
PubMed Identifier
26209417
Citation
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.
Results Reference
result
PubMed Identifier
22286049
Citation
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.
Results Reference
result
PubMed Identifier
26868079
Citation
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.
Results Reference
result
PubMed Identifier
25922895
Citation
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.
Results Reference
result
PubMed Identifier
30772830
Citation
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.
Results Reference
result

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Basic Life Support by Children

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