- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Istanbul
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Kadıköy, Istanbul, Turcja (Türkiye)
- Istanbul Medeniyet University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall eFAST Performance Score
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Error-Free Anterior Lung Window Performance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- EFAST-EDU-2025-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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