- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, 칠레, 7700950
- 모병
- Pontificia Universidad Catolica de Chile
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연락하다:
- Marcia A Corvetto, Associate professor
- 전화번호: 56997423370
- 이메일: marciacorvetto@gmail.com
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연락하다:
- Pablo Miranda, Assistant professor
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Medicine students
Exclusion Criteria:
- No exclusion Criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Performance assessment
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ICSAD measurement
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 251205008
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Synchronous direct feedback에 대한 임상 시험
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Istituto Ortopedico Galeazzi모병수술 후 혈종, 고관절 치환술, 수술이탈리아
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Institute of Cancer Research, United KingdomCancer Research UK; University of Manchester; University of Sussex완전한
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Coloplast A/S완전한
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Xuanwu Hospital, Beijingthe Alberto Santos Dumont Association for Research Support알려지지 않은