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

2026年6月16日 更新者:Pontificia Universidad Catolica de Chile

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

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利、7700950
        • 招聘中
        • Pontificia Universidad Católica de Chile
        • 接触:
        • 接触:
          • Pablo Miranda, Assistant professor

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Medicine students

Exclusion Criteria:

  • No exclusion Criteria

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器: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).
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).
实验性的: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Performance assessment
大体时间:8 weeks
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.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
ICSAD measurement
大体时间:8 weeks
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.
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月28日

初级完成 (估计的)

2026年12月27日

研究完成 (估计的)

2027年3月27日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 251205008

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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