Virtual Simulation-Based Training for Surgical Simulation

Overseen By Ganesh Sankaranarayanan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Less than 5 years experience

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

Compensation: Varies

Number of Visits: 17

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation. There are 3 Aims for this study that the investigator will test, but the Aim that is the interventional portion of this study is only reported here in Aim 2 - Establish the validity and effectiveness of high-fidelity immersive virtual simulation-based training in improving operating room quality and safety.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Immersive Multi-player Virtual Surgical Safety Checklist Training Simulator?

Research shows that surgical simulation technology, like virtual simulators, significantly improves surgical skills by reducing operating times, increasing efficiency, and decreasing errors, which enhances patient safety and outcomes. ^{1 2 3 4 5}

Is virtual simulation-based training for surgical simulation safe for humans?

The research articles provided focus on the use of surgical safety checklists to improve communication and reduce complications in surgery, but they do not provide specific safety data on virtual simulation-based training for surgical simulation. ^{6 7 8 9 10}

How is the Immersive Multi-player Virtual Surgical Safety Checklist Training Simulator treatment different from other treatments for surgical training?

This treatment is unique because it uses immersive multi-player virtual reality to train surgical teams, focusing on both technical and nontechnical skills, which is more effective than individual learning methods. It provides a collaborative environment that simulates real-life surgical scenarios, enhancing teamwork and communication skills essential for complex surgeries. ^{11 12 13 14 15}

Research Team

Ganesh Sankaranarayanan, PhD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for individuals involved in surgical operations, likely healthcare professionals like surgeons and operating room staff. The goal is to improve their skills using a virtual reality simulation that mimics real-life surgery scenarios.

Inclusion Criteria

OR service with a minimum of 5 years of experience that includes surgeons, residents, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists

Exclusion Criteria

OR team members (surgeons, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists) with less than 5 years of experience

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test and Initial Training

Participants take a knowledge assessment test and perform the surgical safety checklist on the simulator. Experimental group practices on the simulator for 8 sessions over three weeks.

3 weeks

8 sessions (in-person)

Post-test and Transfer Test

Participants take a post-test and perform surgical safety checklists in a simulated operating room to assess predictive validity.

1 week

1 session (in-person)

Extended Simulation Training

Group 3 participants continue to practice on the simulator once per week for an additional two months.

2 months

8 sessions (in-person)

Follow-up

Participants are monitored for changes in surgical safety checklist performance at 1, 3, and 5 months post intervention.

5 months

Treatment Details

Interventions

• Immersive Multi-player Virtual Surgical Safety Checklist Training Simulator

Trial Overview The study tests the effectiveness of an Immersive Multiplayer Virtual Surgical Safety Checklist Training Simulator. It aims to see if this high-tech training can make surgeries safer and improve overall quality in the operating room.

Participant Groups

Group I: Group 3: Simulation with repeated reinforcement Experimental Treatment 1 Intervention

Group 3 participants will practice on the simulator one session every day for 4 weeks and will continue to practice on the simulator once per week for an additional two months to a total of 8 sessions.

Group II: Group 2: Simulation Experimental Treatment 1 Intervention

Group 2 will practice on the simulator one session every day for 4 weeks.

Group III: Group 1: Control Active Control 1 Intervention

Group 1 participants will not receive any additional training except for instutionally mandated training

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: "A Brush Too Broad" (Validation, Global Rating Scales, and the Like…What Do They Really Mean?). [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual simulation in the surgical world. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Surgical Games: A Simulation-Based Structured Assessment of Orthopedic Surgery Resident Technical Skill. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Initial implementation of mixed reality simulation targeting teamwork and patient safety. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

Validity of a patient-specific percutaneous nephrolithotomy (PCNL) simulated surgical rehearsal platform: impact on patient and surgical outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Development and validation of the SURgical PAtient Safety System (SURPASS) checklist. [2022]

7. England pubmed.ncbi.nlm.nih.gov

CheckPOINT: a simple tool to measure Surgical Safety Checklist implementation fidelity. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Use of the surgical safety checklist to improve communication and reduce complications. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A mixed methods study of challenges in the implementation and use of the surgical safety checklist. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Development and validation of patients' surgical safety checklist. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Say, What Is on Your Mind? Surgeons' Evaluations of Realism and Usability of a Virtual Reality Vertebroplasty Simulator. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Validation study of a virtual reality robotic simulator--role as an assessment tool? [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Collaborative Team Training in Virtual Reality is Superior to Individual Learning For Performing Complex Open Surgery: A Randomized Controlled Trial. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Surgical education and surgical simulation. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

The role of virtual reality in surgical training in otorhinolaryngology. [2007]