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NCT Number: NCT06917183

Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB)

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT southwestern Medical Center

Dallas, Texas, 75390, United States

Location contact

Ganesh Sankaranarayanan, PhD

CONTACT

[email protected]

2067347458

Ganesh Sankaranarayanan, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

The study will use a mixed within and between subjects' design with two groups - control, and simulation. Due to the dedicated time needed to enroll and complete the sessions along with the need for complete novice subjects, the investigator will recruit medical students at UT Southwestern Medical Center (UTSW) from all years for the simulation group. For the Control group, the investigator will recruit participants from our OR team with a minimum of 5 years of experience at Clements University Hospital (CUH) consisting of surgeons, residents, scrub techs, circulating nurses, anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs) or first assists. Subjects will be randomized into either a control group (didactic) or experimental group (didactic with virtual simulation training). Pre-test: Both groups will take a knowledge assessment test (Multiple choice) that measures baseline knowledge in performing surgical safety checklist. Immediately after that, the participants will be asked to perform the surgical safety checklist once on the simulator. For uniform standard, all participants will choose the role of a surgeon. Both groups will then complete an online introductory module on surgical safety checklists that will be specifically created for use at UTSW. Subjects in the experimental group will then practice on the simulator for 8 sessions with each session not exceeding an hour. The 8 sessions will be completed within three weeks of the pre-test. Deliberate practice will be used to achieve satisfactory scores in the training. A total of 3 scenarios, which will be selected from expert inputs and align with institute priority, will be selected for the training. Post-test: At the end of three weeks, subjects from both groups will once again take the online knowledge test followed by performing the checklists on the simulator. Transfer test: One week after post-test, subjects from both groups will perform surgical safety checklists in a simulated operating room at the UTSW Simulation Center to assess predictive validity. For other team members during the transfer test, the investigator will use the research team and volunteers from the surgical service team. The transfer test performance will be videotaped for assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator

Other

Training for performing surgical safety checklist for a period of 4 weeks.

Primary outcomes

  1. Change in surgical safety checklist performance at 1 month post intervention

    Time frame: Baseline, at one month post intervention

    Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB

  2. Change in surgical safety checklist performance at 3 months post intervention

    Time frame: Baseline, at 3 months post intervention

    Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB

  3. Change in surgical safety checklist performance at 5 months post intervention

    Time frame: Baseline, at 5 months post intervention

    Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB

Study contacts

Contact information is provided by the study sponsor or research team.

Ganesh Sankaranarayanan, PhD

CONTACT

[email protected]

2067347458

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.