- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07790497
Video-Based Versus Bedside eFAST Training in Final-Year Medical Students
Comparative Effectiveness of Video-Based and Bedside Teaching for eFAST Training in Final-Year Medical Students: A Randomised Controlled Educational Trial
This study compared two methods of teaching the Extended Focused Assessment with Sonography for Trauma (eFAST) examination to final-year medical students. Participants were randomly assigned in a 1:1 ratio to either a 60-minute standardized video-based training session or a 60-minute instructor-led bedside training session. Both groups received the same educational content, for the same duration, from the same instructor.
Within one hour after completing the training, each participant performed an individual eFAST examination on a healthy volunteer. Performance was assessed by an evaluator who was unaware of the participant's training group, using an eFAST Image Acquisition Checklist. The study compared overall immediate eFAST performance between the two teaching methods and also examined performance in individual eFAST examination windows.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This was a single-center, parallel-group, individually randomized educational trial involving final-year medical students undertaking an emergency medicine clerkship. Participants with previous formal ultrasound training or prior practical ultrasound experience were excluded. One hundred consenting participants were randomized, with 50 assigned to standardized video-based eFAST training and 50 assigned to instructor-led bedside eFAST training.
Both interventions lasted 60 minutes and covered the same theoretical and practical eFAST content. Participants underwent an individual practical assessment on a healthy volunteer within one hour after training. Outcome assessors were blinded to training allocation. Performance was assessed using an eFAST Image Acquisition Checklist, which generated an overall score ranging from 0 to 100 and window-specific classifications of error-free performance.
No primary outcome was designated in advance of the analysis. For the present report and retrospective trial registration, the overall eFAST performance score is designated as the primary outcome, while the window-level comparisons are considered exploratory secondary outcomes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Kadıköy, Istanbul, Turquía (Türkiye)
- Istanbul Medeniyet University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Current enrollment as a final-year (sixth-year) medical student at İstanbul Medeniyet University Faculty of Medicine.
Participation in the emergency medicine clerkship during the study period. Provision of written informed consent before randomization.
Exclusion Criteria:
Previous formal ultrasound training. Prior practical ultrasound experience. A physical condition that could interfere with performing an ultrasound examination.
Declining or not providing written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Video-Based eFAST Training
Participants received a 60-minute standardized video-based eFAST training session.
The video was recorded on a healthy volunteer and covered the theoretical principles and practical performance of eFAST, including clinical indications, ultrasound physics, examination windows, transducer selection, probe positioning and orientation, image optimization, normal anatomical landmarks, and representative pathological images.
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Participants watched a standardized 60-minute instructional video covering the theoretical principles and practical performance of eFAST.
The video was recorded on a healthy volunteer and included demonstrations of the examination with visual annotation.
Content included the principles and clinical indications of eFAST, ultrasound physics, examination windows, transducer selection, probe positioning and orientation, image optimization, normal anatomical landmarks, and representative pathological images.
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Comparador activo: Instructor-Led Bedside eFAST Training
Participants received a 60-minute instructor-led bedside eFAST training session on a healthy volunteer.
The session covered the same theoretical and practical content as the video-based intervention and included live demonstration of each eFAST examination window followed by supervised practice, during which each participant performed the examination once under direct guidance.
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Participants received a 60-minute instructor-led bedside training session delivered by the same emergency physician on a healthy volunteer.
The session covered the same theoretical and practical eFAST content as the video-based intervention and included live demonstration of each examination window followed by supervised practice, during which each participant performed the examination once under direct guidance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall eFAST Performance Score
Periodo de tiempo: Within 1 hour after completion of the assigned training session
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Overall practical eFAST performance was assessed using the eFAST Image Acquisition and Interpretation Assessment Checklist.
The checklist comprised 21 image-acquisition items across six eFAST windows and one image-differentiation component.
Image-acquisition items contributed a maximum of 84 points and image differentiation contributed a maximum of 16 points, yielding a total score from 0 to 100, with higher scores indicating better performance.
For this retrospective registration, the overall performance score is designated as the primary outcome; no primary outcome was prospectively designated before the analysis.
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Within 1 hour after completion of the assigned training session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Error-Free Anterior Lung Window Performance
Periodo de tiempo: Within 1 hour after completion of the assigned training session
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Proportion of participants who completed all required steps for the anterior lung eFAST window correctly.
Any incorrectly performed required step resulted in classification as not error-free.
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Within 1 hour after completion of the assigned training session
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Error-Free Subxiphoid Window Performance
Periodo de tiempo: Within 1 hour after completion of the assigned training session
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Proportion of participants who completed all required steps for the subxiphoid eFAST window correctly.
Any incorrectly performed required step resulted in classification as not error-free.
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Within 1 hour after completion of the assigned training session
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Error-Free Right Upper Quadrant Window Performance
Periodo de tiempo: Within 1 hour after completion of the assigned training session
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Proportion of participants who completed all required steps for the right upper quadrant eFAST window.correctly.
Any incorrectly performed required step resulted in classification as not error-free.
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Within 1 hour after completion of the assigned training session
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Error-Free Left Upper Quadrant Window Performance
Periodo de tiempo: Within 1 hour after completion of the assigned training session
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Proportion of participants who completed all required steps for the left upper quadrant eFAST windowcorrectly.
Any incorrectly performed required step resulted in classification as not error-free.
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Within 1 hour after completion of the assigned training session
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Error-Free Pelvic Window Performance
Periodo de tiempo: ithin 1 hour after completion of the assigned training session
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Proportion of participants who completed all required steps for the pelvic eFAST window correctly.
Any incorrectly performed required step resulted in classification as not error-free.
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ithin 1 hour after completion of the assigned training session
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- EFAST-EDU-2025-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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