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Идёт набор NCT07659145

Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block

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Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Asynchronous distance feedback, Synchronous direct feedback.
Кому может быть актуально
Состояния в реестре: Feedback. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чили
Следующий шаг
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Официальное название

Simulation-based Training for Ultrasound-guided Popliteal Sciatic Nerve Block Performance: a Randomized Non-inferiority Study Comparing Direct Synchronous Feedback With Remote Asynchronous Feedback

Обзор

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

Подробное описание

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.

Вмешательства

  • Другое Asynchronous distance feedback
    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 erro
  • Другое Synchronous direct feedback
    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).

Первичные конечные точки

  • Performance assessment [Срок оценки: 8 weeks]
Вторичные конечные точки (1)
  • ICSAD measurement [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Medicine students

Критерии исключения

  • No exclusion Criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Чили · 1 центр
  • Pontificia Universidad Catolica de Chile — Santiago

Публикации

  • 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. PMID 41219804
  • 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 1 PMID 38888993

Идентификаторы

NCT: NCT07659145 · 251205008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗