CompletedNot Applicable

Mixed-reality REBOA Simulator With Virtual Coaching

United States14 participantsStarted 2022-02-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years of age Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 hours

Trial details

NCT IDNCT05062928

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-11

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