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临床试验/NCT05062928
NCT05062928已完成不适用

Assessment of a Mixed-reality Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) Training Simulator With Virtual Coach for Mastery Learning.

University of Florida1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Virtual coach is non-inferior in REBOA training to an average human instructor

研究概览

简要总结

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a life-saving emergency procedure that is highly suited for simulation-based training.

This study aims to assess the validity of our REBOA simulator with virtual coach (or live quantitative feedback) for mastery learning.

The hypotheses are:

H0: Virtual coach is non-inferior in REBOA training to an average human instructor.

H1: Virtual coach is inferior in REBOA training to an average human instructor. We expect to learn whether the virtual coach is non-inferior to an average human instructor for US-guided REBOA training. Additionally, we expect to find which determinants affect success rate most and to assess the needs for the current simulator system's future software development.

详细描述

Methods:

Study design: This is a multi-center randomized simulation study. Setting, location, participants: This multi-center study will be held at University of Florida (UF) Health and Madigan Health centers. Planned time is between June 01 to October 31, 2021. The study population will be trainees (students, residents, fellows, and physicians) working at UF Health Center and Madigan Health Center. Exclusion criteria are: i. not obtaining informed consent, ii. inability to complete all the procedures.

Timeframe of training and data collection: June 01 to October 31, 2021 Learner or trainee population: Learners will be healthcare staff in two hosting institutions. Trainers will be the academic staff from UF Health and Madigan Medical Center.

Measurements:

Development and pilot testing of assessment tool: REBOA simulator will be developed at the Center for Safety, Simulation, and Advanced Learning Technologies (CSSALT). Pilot testing will be on primary team members. The trainer will play confederate nurse role and assist the participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •>18 years of age

排除标准

  • •i. not obtaining informed consent,
  • •ii. inability to complete all the procedures,
  • •iii. Completed a REBOA course iv. Used the US-guided REBOA simulator in any way

研究组 & 干预措施

Virtual coaching group

Experimental

In this group, the virtual coach will train and assess.

干预措施: Virtual coach (Other)

Human instructor group

No Intervention

In this group, a human instructor will train, but the virtual coach will assess.

结局指标

主要结局

Virtual coach is non-inferior in REBOA training to an average human instructor

时间窗: 2 hours

The study will compare the virtual coach group and human instructor groups by means of reaching to mastery. Mastery is defined as two consecutive successful REBOA insertion to zone 1 and zone 2. The investigators defined the success criteria in the methods section in detail.

次要结局

  • Define the time required for a complete REBOA insertion on a simulator(2 minutes)
  • Define the time required the time to mastery(2 hours)
  • Association of success rates and complications on the simulator to spatial ability(8 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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