NCT06016153

Brief Summary

Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival. There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS. The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.

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
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 17, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 9, 2024

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 17, 2023

Last Update Submit

February 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • End of training BLS skill assessment based on a checklist

    BLS skills measured right after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by two instructors and the software of InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary.

    up to two hours

Secondary Outcomes (2)

  • BLS skill assessment after 2 months based on a checklist

    2 months

  • BLS skill assessment after 6 months based on a checklist

    6 months

Study Arms (2)

Instructor feedback

ACTIVE COMPARATOR

BLS training participants will receive feedback from an experienced instructor certified by European Resuscitation Council on the depth and frequency of chest compressions, duty cycle, chest recoil and the quality of ventilation.

Other: Instructor feedback

Software feedback

EXPERIMENTAL

BLS training participants will receive feedback based on a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary) on the quality of chest compression (exact frequency, depth of chest compression, chest recoil and duty cycle) and tidal volume during ventilation.

Other: Software based feedback

Interventions

Feedback is given by the data of a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary).

Software feedback

Feedback is given by the opinion and observation of an experienced instructor.

Instructor feedback

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school teenagers participating in the education of Óbudai High School, Budapest
  • Written informed consent received from participants and their parents to participate in the study

You may not qualify if:

  • No written informed consent provided by the student or parent
  • Any injury or health issue influencing the efficacy of BLS skill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Óbudai Gimnázium

Budapest, Hungary

RECRUITING

Related Publications (1)

  • Maar C, Zima E, Nagy B, Pal-Jakab A, Szvath P, Kiss B, Frituz G, Gal J, Merkely B, Kovacs E. The investigation of the efficiency of basic life support education among high school students: Protocol, design and implementation of an interventional, prospective longitudinal, individually randomised, parallel 1:1 grouped trial. Resusc Plus. 2024 Feb 28;18:100585. doi: 10.1016/j.resplu.2024.100585. eCollection 2024 Jun.

Study Officials

  • Endre Zima, PhD

    Semmelweis University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 29, 2023

Study Start

December 1, 2023

Primary Completion

February 29, 2024

Study Completion

July 31, 2024

Last Updated

February 9, 2024

Record last verified: 2023-08

Locations