- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07649343
Online Booster Training System for Improving CPR Quality (OBS-CPR)
Improving CPR Quality With Online Booster Training System in Medical Students: A Randomized Controlled Trial
Improving CPR Quality with Online Booster Training System in Medical Students: A Randomized Controlled Trial
- Objective To explore the effect of the online booster training system on cardiopulmonary resuscitation (CPR) skill retention among adult CPR learners.
Participants Medical university students, who have received the standardized offline AHA BLS course.
Inclusion Criteria
- Aged ≥ 18 years
- no CPR training within the past 3 years
- Full attendance and completion of the initial offline CPR course
- Voluntary participation and signed informed consent
- Availability of smart phones, tablets or computers for online training and follow-up Exclusion Criteria
- Physical limitations preventing high-quality chest compression (e.g., severe carpal tunnel syndrome, spinal diseases, etc.)
- Prior CPR learning experience or potential access to additional spontaneous CPR booster training after initial training.
- Unavailability to complete follow-up assessments within the study period for any reason.
Randomization Participants will be randomly allocated (1:1) to either of groups using the online system, with an online random number generator (www.randomizer.org). The numbers were randomly assigned to consented participants by a person, who is not a member of the research team.
Blinding: Outcome assessors, offline training instructors and statistical analysts are blinded. Due to the nature of the intervention, participants are not blinded.
Interventions Intervention group (Online Booster Training Group) Requirements: Within 3 months after initial training, participants should complete full online training session at least once per month.
Platform: Qilu Online Booster Training System for Adult Cardiopulmonary Resuscitation.
Contents: Teaching review (video lectures); practice assessment.
Control group (No Booster Training Group) No booster training of any form was provided. Participants only returned for outcome assessment at the designed time.
Outcomes 5.1 Primary Outcome Excellent CPR, which was defined as at least 90% guideline-compliance for depth, rate and recoil of chest compression.
5.2 Secondary Outcome (i) compression depth (mm), assessed with the certified CPR manikins (ii) compression rate (per minute), assessed with the certified CPR manikins (iii) Percentage of compression depth > 50 mm (iv) Percentage of CC (chest compression) with rate of 100-120/min (v) Percentage of CC with complete recoil. (vi) The pass rate of theoretical test
- Sample Size Calculation The sample size was estimated based on the primary outcome measure. A previous study showed that the proportion of "excellent CPR" without booster training is 88%. We expected to detect a 10% difference in the proportion of excellent CPR between groups. Based on these assumptions, an alpha of 0.05 and a power of 0.8, assuming a dropout of 5%, we will aim to include 105 participants per group, that is, a total of 210 participants.
- Statistical Analysis variables will be assessed for normal distribution and reported as means (SD) or medians (IQR), whichever is appropriate. Continuous data will be compared using a Student's t-test or Mann-Whitney U test, whichever is appropriate. Categorical variables will be reported as numbers (%) and compared using χ2 or Fisher's exact tests, whichever is appropriate. All baseline variables and outcome data variables will also be compared between the two study groups using the abovementioned tests. In case of confounding variables, we will correct comparisons on the outcome measures between the study groups for these confounders using analysis of covariance. A p-value of <0.05 will be considered statistically significant. Analyses will be performed using SPSS V.25
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jian Zhang, Dr.
- Número de telefone: +86 18560082462
- E-mail: 18366119306@163.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Aged ≥ 18 years
- no CPR training within the past 3 years
- Full attendance and completion of the initial offline CPR course
- Voluntary participation and signed informed consent
- Availability of smart phones, tablets or computers for online training and follow-up
Exclusion Criteria:
- Physical limitations preventing high-quality chest compression (e.g., severe carpal tunnel syndrome, spinal diseases, etc.)
- Prior CPR learning experience or potential access to additional spontaneous CPR booster training after initial training
- Unavailability to complete follow-up assessments within the study period for any reason.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Traditional CPR Group
|
|
|
Experimental: OBS-CPR Group
|
Intervention group (Online Booster Training Group) Requirements: Within 3 months after initial training, participants should complete full online training session at least once per month. Platform: Qilu Online Booster Training System for Adult Cardiopulmonary Resuscitation. Contents: Teaching review (video lectures); practice assessment. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Excellent CPR, which was defined as at least 90% guideline-compliance for depth, rate and recoil of chest compression.
Prazo: Up to 12 months
|
Up to 12 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
compression depth (mm)
Prazo: Up to 12 months
|
Up to 12 months
|
|
compression rate
Prazo: Up to 12 months
|
Up to 12 months
|
|
Percentage of compression depth > 50 mm.
Prazo: Up to 12 months
|
Up to 12 months
|
|
Percentage of CC (chest compression) with rate of 100-120/min
Prazo: Up to 12 months
|
Up to 12 months
|
|
Percentage of CC with complete recoil
Prazo: Up to 12 months
|
Up to 12 months
|
|
The pass rate of theoretical test, at 3 months after initial training.
Prazo: Up to 12 months
|
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- KYLL-2026-04-016
Plano para dados de participantes individuais (IPD)
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