- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292532
Learning Cardiopulmonary Resuscitation in the School Setting: RCP-KNOW Project. (RCP-KNOW)
Out-of-hospital Cardiorespiratory Arrest and Learning Cardiopulmonary Resuscitation in the School Setting: Evidence Synthesis
Title: Out-of-hospital cardiorespiratory arrest and learning cardiopulmonary resuscitation in the school setting: evidence synthesis. CPR-KNOW PROYECT.
Background: The high incidence, associated morbidity and mortality, and the great individual, social and economic impact of out-of-hospital cardiorespiratory arrest (OHCA) make it a priority for all health systems worldwide. To increase the rates of potential first responders who act appropriately, applying basic life support (BLS) measures in the OHCA, the European Resuscitation Council includes among its latest recommendations the training of all school children through the "Kids Save Lives" initiative.
Objectives: to determine, through a randomized clinical trial, the effectiveness of two training strategies for increasing theoretical and practical knowledge of BLS in schoolchildren and adolescents.
Methodology: To evaluate the effectiveness of two (Cardiopulmonary Resuscitation) CPR teaching interventions in improving the following outcome variables: theoretical knowledge and practical skills, CPR quality; as well as its relationship with the anthropometric, sociodemographic and physical condition variables of the schoolers.
- Intervention group 1 (IG1): a 2-hour theoretical-practical session on the BLS sequence taught by a Nursing professional performing the practice with a mannequin. Instructor/school ratio: 1/25 for the theoretical session and a school/mannequin ratio: 2-3/1.
- Intervention group 2 (IG2): a session with short video (approximately 5-10 min) and other teaching resources (puzzle), without practice on a mannequin. Video/school ratio: 1/25 and a school/teaching resource (puzzle) ratio: 1/1.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diana P Pozuelo-Carrascosa, Dr.
- Phone Number: 926053755
- Email: dianap.pozuelo@uclm.es
Study Locations
-
-
Cuenca
-
Cuenca, Cuenca, Spain, 16002
- Recruiting
- CEIP Ciudad Encantada
-
Contact:
- Diana P Pozuelo Carrascosa, Dr
- Phone Number: +34655412253
- Email: dianap.pozuelo@uclm.es
-
Contact:
- Email: dianap.pozuelo@uclm.es
-
Cuenca, Cuenca, Spain, 16004
- Recruiting
- CEIP Isaac Albeniz
-
Contact:
- Diana P Pozuelo Carrascosa, Dr
- Phone Number: +34655412253
- Email: dianap.pozuelo@uclm.es
-
Contact:
- Email: dianap.pozuelo@uclm.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Schools that have at least one complete year of 1st, 2nd, 3rd, 4th, 5th and 6th year of Primary Education, in which the School Council has given its approval for their participation.
- Schoolchildren who wish to participate must:
- Belong to the courses from 1st to 6th grade of Primary Education
- Understand the written and spoken Spanish language
- Not have any physical, mental or cognitive pathology that prevents them from participating in the project.
- Their father/mother or guardian must have signed the informed consent to be able to participate in the project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional CPR teaching
A 2-hour session of conventional theoretical-practical training with a mannequin, about the BLS sequence to follow in a CPR-OHCA, adapted to the age of schoolchildren, and taught by nursing professionals.
Theoretical-practical training on the operation of the semi-automatic defibrillator.
|
Comparation of two type of Cardiopulmonary Resuscitation Teaching Intervention in Children: traditional teaching vs video with puzzle.
|
|
Experimental: Video and teaching material
A short video (5min) in which the basic sequence of BLS to follow in a CPR-OHCA is explained, accompanied by a puzzle adapted to the age of the children in which the BLS sequence is reflected, but without practice on a mannequin.
Theoretical training included in the video about the operation of the semi-automatic defibrillator.
|
Comparation of two type of Cardiopulmonary Resuscitation Teaching Intervention in Children: traditional teaching vs video with puzzle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Theoretical CPR Knowledge
Time Frame: On the same day as the intervention, before (pre-intervention) and immediately after this (post-intervention) and follow-up (8 months later)
|
Theoretical CPR Knowledge measured by a questionnaire.
|
On the same day as the intervention, before (pre-intervention) and immediately after this (post-intervention) and follow-up (8 months later)
|
|
CPR Practice Skills
Time Frame: On the same day as the intervention immediately after this (post-intervention) and follow-up (8 months later)
|
CPR Practice Skills measured with a checklist
|
On the same day as the intervention immediately after this (post-intervention) and follow-up (8 months later)
|
|
Quality of CRP
Time Frame: On the same day as the intervention, immediately after this (post-intervention) and follow-up (8 months later)
|
Quality of CPR measured by Little-Anne Mannequin.
|
On the same day as the intervention, immediately after this (post-intervention) and follow-up (8 months later)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anthropometry: weight
Time Frame: Immediately post-intervention
|
Corporal weight measured in Kilograms
|
Immediately post-intervention
|
|
Anthropometry: height
Time Frame: Immediately post-intervention
|
Height measured in centimeters
|
Immediately post-intervention
|
|
Anthropometry: BMI
Time Frame: Immediately post-intervention
|
BMI calculated by the follow form: weight (kg)/height*2 (m)
|
Immediately post-intervention
|
|
Anthropometry: corporal composition
Time Frame: Immediately post-intervention
|
Percentage of fat mass and percentage of lean mass.
Measured by bioimpedance scale Tanita MC-780MA N
|
Immediately post-intervention
|
|
Cardiorespiratory fitness
Time Frame: Immediately post-intervention
|
Cardiorespiratory fitness measured through Course Navette Test
|
Immediately post-intervention
|
|
Muscular strength
Time Frame: Immediately post-intervention
|
Muscular strength measured through dynamometry and horizontal jump with feet together
|
Immediately post-intervention
|
|
socioeconomic variables
Time Frame: immediately post-intervention
|
socioeconomic variables such as: the academic level and economic level of the father and mother
|
immediately post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SBPLY/23/180225/000060 (Other Grant/Funding Number: Junta de Comunidades de Castilla-La Mancha and FEDER Funds)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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