Virtual Coach for Simulation Training

(REBOASIM Trial)

Overseen By Yahya A Acar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: No consent, Incomplete procedures, Prior REBOA course, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual coach designed to teach a life-saving procedure called REBOA, used in emergencies to control bleeding. The trial compares the effectiveness of the virtual coach with that of a human instructor. It seeks to determine if the virtual coach is equally effective and to identify factors contributing to its success. Individuals who have never taken a REBOA course or used the related simulator may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative training methods that could save lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this virtual coach is safe for REBOA training?

Research has shown that the virtual coach for REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) training helps learners master this emergency procedure. This simulator provides realistic practice with virtual ultrasound guidance and feedback. It has undergone testing for ease of use and acceptance in training settings.

As a training tool, not a medical treatment, traditional safety concerns do not apply to the virtual coach. However, its effectiveness in training scenarios has been evaluated. Studies have demonstrated that participants can successfully use this mixed-reality tool to learn the REBOA procedure. No negative effects have been reported from using the simulator. Participants find the training helpful and engaging, indicating it is well-received as a learning tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Virtual Coach for Simulation Training because it could revolutionize how training and assessment are conducted in educational settings. Unlike traditional methods that rely solely on human instructors, this virtual coach provides an innovative way to train and assess learners. The virtual coach offers personalized feedback and adaptive learning techniques, which can lead to more efficient and tailored educational experiences. This technology could make training more accessible and consistent, ultimately enhancing learning outcomes and potentially reducing costs.

What evidence suggests that the virtual coach is effective for REBOA training?

Research shows that virtual coaching for REBOA, a critical emergency procedure, holds promise. In this trial, the virtual coaching group will receive training and assessment from the virtual coach. Studies have found that virtual coaching can effectively train individuals by providing real-time feedback comparable to human instructors. The human instructor group will receive training from a human instructor, but the virtual coach will still assess their performance. Early results suggest that trainees find virtual reality and mixed-reality simulators practical and acceptable for learning. The virtual coach creates realistic scenarios and offers guidance, helping users practice catheter insertion and ultrasound techniques effectively. Overall, these tools prove useful and effective for training in medical procedures. ^{1 4 5 6 7}

Who Is on the Research Team?

Samsun Lampotang

Principal Investigator

Univeristy of Florida

Are You a Good Fit for This Trial?

This trial is for individuals over 18 years old interested in REBOA training. It's not suitable for those who've already completed a REBOA course, used the US-guided REBOA simulator, or cannot give informed consent and complete all procedures.

Inclusion Criteria

I am older than 18 years.

Exclusion Criteria

I cannot complete all the required procedures for the study.

I have completed a REBOA course.

Used the US-guided REBOA simulator in any way

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo hands-on training with either a virtual coach or human instructor until mastery is achieved

4 months

Individual sessions scheduled based on availability

Assessment

Participants are assessed on their ability to perform REBOA insertion using the simulator

2 hours

Follow-up

Participants are monitored for skill retention and any complications post-training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual coach

Trial Overview The study tests if a virtual coach is as good as an average human instructor for teaching the emergency procedure called REBOA. Participants will use a simulator with either live feedback from the virtual coach or from a human to learn this skill.

How Is the Trial Designed?

Group I: Virtual coaching group Experimental Treatment 1 Intervention

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

Group II: Human instructor group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Published Research Related to This Trial

The virtual reality femoral nailing simulator, which integrates haptic feedback and image intensifier functionality, has been validated as an effective educational tool for orthopedic training, showing good authenticity and content validity among participants.

Surgeon experience significantly influenced performance on the simulator, with more experienced surgeons completing tasks faster and more efficiently, indicating the simulator's potential for enhancing technical skill development in surgical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of a Virtual Reality Haptic Femoral Nailing Simulator. Racy, M., Barrow, A., Tomlinson, J., et al.[2021]

The study found that while the Nintendo Wii bowling simulator had a good test-retest reliability (intraclass correlation coefficient of 0.76), it did not accurately predict real-world bowling performance, showing no significant correlation (Pearson's r = 0.06).

This highlights the need for evidence-based validation of simulation-based training programs in medicine, as the findings suggest that skills measured in a virtual environment may not transfer effectively to real-life scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lack of correlation between performances in a simulator and in reality]. Konge, L., Bitsch, M.[2014]

High fidelity simulation is an effective training tool for developing teamwork skills in high-risk industries like healthcare, aviation, and nuclear power, as it allows for controlled practice and feedback in a safe environment.

The authors emphasize that simulation fidelity should not be viewed as a one-size-fits-all solution; instead, the design and goals of the training are crucial for its effectiveness, and they provide guidelines to enhance the training process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of simulation for training teamwork skills in health care: how low can you go? Beaubien, JM., Baker, DP.[2022]

Augmented reality (AR) and virtual reality (VR) are increasingly used for life support training, providing a safe and immersive learning environment for healthcare providers and students.

Current research shows a lack of studies on multiplayer experiences and haptic feedback in AR/VR training tools, highlighting the need for further investigation to determine if these technologies are as effective or better than traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Viewpoint: Virtual and Augmented Reality in Basic and Advanced Life Support Training. Ricci, S., Calandrino, A., Borgonovo, G., et al.[2022]

The integration of gaming technologies with medical training aims to create realistic simulations for mass casualty incidents, allowing medical professionals to practice in scenarios that reflect complex, real-life situations.

This program, developed in collaboration with Forterra Systems and Stanford University, focuses on enhancing the physiological realism of computer-generated avatars, which will help improve the training and preparedness of healthcare teams in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatars alive! The integration of physiology models and computer generated avatars in a multiplayer online simulation. Kusumoto, L., Heinrichs, WL., Dev, P., et al.[2008]

The study proposes a classification framework for evaluating virtual reality (VR) training tools, which can range from complex emergency response simulations to basic surgical skill trainers, ensuring that each type of simulation is matched with appropriate skill assessments.

This framework aims to standardize the evaluation of VR training effectiveness by incorporating both objective measures (like task time and error rates) and subjective feedback, enhancing the usability and pedagogical impact of VR in health training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical education through virtual worlds: the HLTHSIM project. Eagleson, R., de Ribaupierre, S., King, S., et al.[2011]

The article reviews the use of live, virtual, and constructive (LVC) simulations in healthcare, highlighting that while these methods are well-established in military training, their application in medical education is still emerging.

The authors suggest that combining two types of simulations (live and virtual, or virtual and constructive) may be a more practical approach for healthcare training, addressing challenges and providing recommendations for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Live Virtual Constructive Simulations in Healthcare Learning. Padilla, JJ., Diallo, SY., Armstrong, RK.[2018]

Medical simulation is increasingly being used to train healthcare professionals in a safe environment, which is crucial for maintaining a culture of safety in medicine and reducing errors.

The integration of medical simulation with human factors engineering can improve the interaction between healthcare practitioners and medical technology, potentially leading to enhanced patient safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation in medicine: addressing patient safety and improving the interface between healthcare providers and medical technology. Hunt, EA., Nelson, KL., Shilkofski, NA.[2019]

In a study involving 69 participants, novices trained in clinical breast examination (CBE) using mixed-reality environments (MREs) with real-time feedback performed as well as or better than experienced practitioners, highlighting the effectiveness of this training method.

A follow-up study with 8 novices showed that skills learned in the MRE transferred successfully to real-world CBE tasks, demonstrating the practical benefits of using MREs for training complex skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time evaluation and visualization of learner performance in a mixed-reality environment for clinical breast examination. Kotranza, A., Lind, DS., Lok, B.[2012]

Involving end users, such as therapists and rehabilitation clients, in the research and implementation of virtual reality (VR) and active video games (AVGs) can significantly improve the alignment of these technologies with their needs, potentially increasing clinical uptake.

The authors identified common benefits from user engagement, including enhanced buy-in from therapists and better technology integration, while also noting challenges in balancing technology capabilities with practical rehabilitation goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in rehabilitation virtual reality implementation research. Proffitt, R., Glegg, S., Levac, D., et al.[2022]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

This review aims to develop and refine a program theory to understand how augmented reality (AR) and virtual reality (VR) can effectively train health and care providers, addressing the mixed evidence on their effectiveness in various settings.

The study will systematically analyze existing theories and empirical evidence to identify the contexts and mechanisms that influence the success of AR/VR training programs, ultimately aiming to enhance the quality of care and promote evidence-based practices in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upskilling health and care workers with augmented and virtual reality: protocol for a realist review to develop an evidence-informed programme theory. Gasteiger, N., van der Veer, SN., Wilson, P., et al.[2023]

The STEPS program, developed at Louisiana State University Health Sciences Center, uses high-fidelity human patient simulators in a mobile mock operating room to train surgical teams, enhancing patient safety through realistic simulations.

Team performance was evaluated through direct observation and a 360-degree assessment, allowing team members to reflect on their own and each other's communication skills, which is crucial for improving teamwork in real clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial implementation of mixed reality simulation targeting teamwork and patient safety. Kozmenko, V., Paige, J., Chauvin, S.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05062928

Mixed-reality REBOA Simulator With Virtual Coaching 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: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10559413/

Development and usability testing of a fully immersive VR ... We aimed to determine the feasibility and acceptance of REBOA training using a fully immersive virtual reality (VR) REBOA simulation, as well as ...

3. simulation.health.ufl.edu simulation.health.ufl.edu/technology-development/augmented-reality-mixed-simulation/reboa-simulator/

REBOA Simulator The REBOA simulator is a mixed-reality tool for practicing REBOA catheter insertion, using realistic models and virtual ultrasound guidance, with a virtual ...

4. researchgate.net researchgate.net/publication/374507330_Development_and_usability_testing_of_a_fully_immersive_VR_simulation_for_REBOA_training

Development and usability testing of a fully immersive VR ... We aimed to determine the feasibility and acceptance of REBOA training using a fully immersive virtual reality (VR) REBOA simulation, as well as assess the ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/location/united-states/FL/Gainesvillle

Gainesvillle, Florida Clinical Research Trials Mixed-reality REBOA Simulator With Virtual Coaching. Methods: Study design: This is a multi-center randomized simulation study. Setting, location ...

6. simulation.health.ufl.edu simulation.health.ufl.edu/wordpress/files/2022/03/REBOA_simulator_one_page_fact_sheet.pdf

Mixed Reality REBOA Simulator Fact Sheet This turnkey, mixed reality simulator is for practicing, learning, teaching and debriefing resuscitative endovascular balloon occlusion of the aorta (REBOA) ...

7. clinconnect.io clinconnect.io/trials/NCT05062928

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