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

16 de junho de 2026 atualizado por: 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

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7700950
        • Recrutamento
        • Pontificia Universidad Católica de Chile
        • Contato:
        • Contato:
          • Pablo Miranda, Assistant professor

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Medicine students

Exclusion Criteria:

  • No exclusion Criteria

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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).
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Performance assessment
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
ICSAD measurement
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de maio de 2026

Conclusão Primária (Estimado)

27 de dezembro de 2026

Conclusão do estudo (Estimado)

27 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

28 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 251205008

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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