- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07659145
Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block
Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block Performance: a Randomized Non-inferiority Study Comparing Direct Synchronous Feedback With Remote Asynchronous Feedback
The goal of this study is to evaluate whether remote asynchronous feedback is non-inferior to direct synchronous feedback during simulation-based training for ultrasound-guided popliteal sciatic nerve block performance. The main questions it aims to answer are:
Does asynchronous feedback achieve technical skill acquisition outcomes comparable to direct synchronous feedback? Can asynchronous feedback optimize teaching resources without compromising training quality?
Researchers will compare two feedback modalities within a simulation-based training program for deliberate practice of ultrasound-guided popliteal sciatic nerve block techniques.
Participants will:
Receive training with either direct synchronous feedback or remote asynchronous feedback Perform simulation-based deliberate practice sessions Be assessed using validated instruments for technical skill performance
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
For the use of the simulation program based on the implementation of a continuous sciatic popliteal nerve block. To achieve this, a simulation program developed by researchers from the School of Medicine of the Pontificia Universidad Católica de Chile will be used for residents from the Emergency Medicine and Critical Care specialty program.
Following approval by the institutional ethics committee, the scenario for 50 students will be prepared. The procedure room will include all the equipment required for performing the intervention, consisting of a video explaining the technique. The study will assess:
(i) Fundamentals and use of echography. (ii) Knowledge of anatomy, physiology, and pharmacology. (iii) Development of dexterity: ability to perform the procedure correctly.
The students will receive a one-hour lecture on the procedure. This assessment will consist of performing a sciatic popliteal nerve block on a simulated clinical scenario. An evaluator blinded to the study objectives will assess participants using a Global Rating Scale (GRS) and a checklist. Additionally, a third evaluator will use the GRS and the checklist remotely (asynchronous feedback).
After the evaluations, the simulation room will remain open throughout the week for students to perform up to five practice sessions. The number of movements and total procedure time will be recorded during each assessment. Students will also complete a satisfaction questionnaire and a final written test after the simulation activity and before the final assessment.
Once the previous evaluation is completed, residents may begin their training.
Subsequently, residents will attend simulation sessions specifically designed to practice the sciatic popliteal nerve block under the guidance of an instructor. Sessions will last 2 hours. Each resident will complete 2 sessions, each separated by 1 week. During the first session, the instructor will explain and supervise correct use of the ultrasound equipment. During the second session, the resident will perform the entire procedure independently. The resident's performance will be recorded and later evaluated through an assessment platform.
One week after training completion, residents will undergo a final assessment using the same tools. The duration of the simulation-based sciatic popliteal nerve block procedure will be recorded. Total procedure time and the number of movements performed during the procedure will also be documented. Additionally, the procedure will be video recorded.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7700950
- Rekrutacyjny
- Pontificia Universidad Catolica de Chile
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Kontakt:
- Marcia A Corvetto, Associate professor
- Numer telefonu: 56997423370
- E-mail: marciacorvetto@gmail.com
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Kontakt:
- Pablo Miranda, Assistant professor
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Medicine students
Exclusion Criteria:
- No exclusion Criteria
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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Aktywny komparator: Synchronous direct feedback (SYNC)
The control group practiced with synchronous direct feedback (SYNC).
The SYNC group attended the simulation laboratory for practice sessions.
Residents were scheduled to practice with the instructor in a one-to-one ses- sion.
The instructor was present during all the sessions and gave instructions and feedback in real time throughout all sessions (traditional face-to-face feedback modality).
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The control group practiced with SYNC.
The SYNC group attended the simulation laboratory for practice sessions.
Residents were scheduled to practice with the instructor in a one-to-one ses- sion.
The instructor was present during all the sessions and gave instructions and feedback in real time throughout all sessions (traditional face-to-face feedback modality).
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Eksperymentalny: Asynchronous distance feedback (ASYNC).
The experimental group practiced with asynchronous distance feedback (ASYNC).
Residents scheduled their sessions and attended the simulation laboratory alone.
The resident logged in to the C1DO1 platform.The student recorded himself, performing the observed technique.
The instructor was not present and provided feedback asynchronously via a C1DO1 platform.
The ASYNC included texts, audio recordings, drawings annotating the trainee's video, and short example error videos from a library.
In addition to the specific feedback in response to residents' videos, instructors also provided an objective assessment based on scores using a 9-item global rating scale (GRS).
The student reviewed their feedback in the platform and identified the skills to improve for the next session.
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The experimental group practiced with ASYNC.
Residents sched- uled their sessions and attended the simulation laboratory alone.
The resident logged in to the C1DO1 platform.
In the platform, the second 4 stages were practical exercises.
The student recorded himself, performing the observed technique.9
The instructor was not present and provided feedback asynchronously via a C1DO1 platform.
The ASYNC included texts, audio recordings, drawings annotating the trainee's video, and short example error videos from a library.
In addition to the specific feedback in response to residents' videos, instructors also provided an objective assessment based on scores using a 9-item global rating scale (GRS).
The student reviewed their feedback in the platform and identified the skills to improve for the next session.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Performance assessment
Ramy czasowe: 8 weeks
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The PRE and POST assessments were videotaped for evaluation by 2 independent and blinded reviewers.
The simulation center staff recorded the assessment videos for a standard vision of the participant's hands and the ultrasound image.
Two reviewers rated each resident's performance using an specific GRS previously validated.
The reviewers were different from the instructors.
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8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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ICSAD measurement
Ramy czasowe: 8 weeks
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Two sensors of a tracking motion device were attached to the operator's hands, during the assess- ment.
The Imperial College Surgical Assessment Device (ICSAD) is a device that tracks hand motion during a procedure using sensors placed on the back of the operator's hands.
In this study, the ICSAD device recorded the total distance traveled by both hands (TPL).
The simulation center staff installed the device in the operators' hands and recorded the data.
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8 weeks
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Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Miranda PF, Araneda AL, Molina NP, Miranda FG, Morrison C, Corvetto MA, Altermatt FR. Simulated-based training for ultrasound-guided popliteal sciatic nerve block: determining the learning curve and transference to real patient. Adv Simul (Lond). 2025 Nov 11;10(1):55. doi: 10.1186/s41077-025-00389-5.
- Corvetto MA, Kattan E, Ramirez G, Besa P, Abbott E, Zamorano E, Contreras V, Altermatt FR. Simulation-Based Training Program for Peripherally Inserted Central Catheter Placement: Randomized Comparative Study of in-Person Training With Synchronous Feedback Versus Distance Training With Asynchronous Feedback. Simul Healthc. 2024 Dec 1;19(6):373-378. doi: 10.1097/SIH.0000000000000805. Epub 2024 Jun 17.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
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
- 251205008
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (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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