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  1. Advancing Regulatory Science

Assessment of Safety and Performance Issues with Extended Reality (XR) Tele-mentoring of an Image-Guided, Clinically Important Procedure

CERSI Collaborators: University of Maryland, Baltimore: Sarah B. Murthi, MD; University of Maryland, College Park: Amitabh Varshney, PhD

FDA Collaborators: Ryan Beams, PhD; Leeda Rashid, MD; Aubrey Shick; Anindita Saha

Project Start Date: December 22, 2022

Regulatory Science Challenge

Currently, most medical data are displayed on flat two-dimensional monitors from a single source and do not combine data streams, which requires the health care provider (HCP) to view multiple displays and the patient during procedures. For example, if a complicated heart ultrasound is being done for hypotension, a HCP would have to look at one screen to see the ultrasound images, and a different screen to see the heart rate and blood pressure. This may be difficult to perform while also managing the heart ultrasound procedure. Head mounted displays with extended reality (XR) technology can be used to project or display medical images and data into the real world so that a HCP can view multiple data streams at the same time and still maintain eye contact with the patient. Also, XR can allow a tele-mentor to visualize the medical data and what the HCP is seeing. The ability for more senior HCPs to provide real-time guidance or oversight to mentees is beneficial to ensure safety and effectiveness of procedure performance. How XR display and mentoring effect human performance is unknown, as are the effects of the possible time-delay in data display (latency) and communication with a telementor who is located at a distant site. Safe and effective XR can create enhanced data displays of data, enable more effective tele-mentoring, and decrease errors related to medical procedures and decision-making.

Project Description and Goals

This study aims to determine how XR tele-mentoring effects the performance of a complex procedure; specifically, a multistep cardiac ultrasound used in assessment of shock. The larger XR related research questions being addressed are:

  • Can synchronized data be displayed with acceptable levels of latency?
  • Does tele-mentoring improve procedure performance?

Investigators will develop an interactive XR display system for tele-mentoring of ultrasound. This will include ability to stream (a) ultrasound and hemodynamic monitor data to the XR headset, (b) data between the mentor and mentee, and (c) communication between the mentor and mentee. Latency and data synchronization will be assessed using the electrocardiogram (ECG) waveform which is present both the ultrasound and monitor data streams. Performance of 5-10 telemedicine/AR guided echocardiograms will also be assessed in simulated patients using a previously validated tool to determine competency.

 

 

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