Augmented Reality Headset as Adjunct Display Monitor in AMIGO

Augmented reality is a computer display technology that represents an incremental improvement
over current computer monitors. Currently, a patient has a pre-procedure or intra-procedure
CT or MRI scan and the scan images are displayed for the proceduralist on computer monitors
in the procedure suite. Typically, only a single, or several selected, cross-sectional images
can be viewed at a given time. With an augmented reality display headset, the pre-procedure
and intra-procedure CT or MR images, including 3D reconstructions, can be displayed on
transparent eyeglasses worn by the proceduralist. Moreover, the images are registered to the
patient's location on the operating table and the images can be continuously updated to
correspond with the body part in the proceduralist's field of view. Augmented reality display
systems could thus decreased perceived work load of a procedure by allowing natural posture
throughout the procedure, streamline and improve the clinical workflow, and provide the
proceduralist with information in a manner that more readily facilitates three-dimensional
understanding of the procedure.

The investigators' overarching goal is to investigate whether use of an augmented reality
display system (utilized in addition to, not as a replacement to, conventional CT and MRI
displays currently available in the procedure suite) streamlines the process of a procedure
and/or provides ease of access to helpful pre-procedure and intra-procedure imaging
information that would be more difficult and time-consuming to obtain with the conventional
imaging display systems.

The three aims are as follows:

1. Determine if the augmented reality display system streamlines workflow.

2. Determine if the augmented reality display system decreases perceived work load.

3. Determine if the augmented reality display system facilitates access to helpful
pre-procedure and intra-procedure imaging information as compared to traditional display
systems.

The investigators hypothesize that the augmented reality display system will streamline
workflow by reducing time required to stop the procedure to look away from the operative
field to the conventional hanging monitor and then look back to the operative field and
reorient to the operative field space.

The investigators hypothesize that the augmented reality display system will decrease
perceived work load by reducing intra-procedure postural strain by projecting the images on a
headset in addition to on traditional monitors hanging from the procedure-suite ceiling.

The investigators hypothesize that the augmented reality display system will facilitate
access to helpful pre-procedure and intra-procedure imaging information because it will allow
real-time projection of three-dimensional reconstructed images over the operative site with
the images reflecting the point-of-view and field-of-view of the proceduralist. While this
information can be generated and projected on traditional display systems, the positioning of
the imaging is likely inferior as it can only mimic the point of view and field of view of
the proceduralist.

All procedures will be performed in accordance with normal standard of care for the condition
being treated. The only difference in care will be that the proceduralist will have imaging
information projected on a headset in addition to on the conventional monitors that hang from
the procedure suite ceiling.

A single REDCap survey will be sent to the performing co-investigator proceduralist
(interventional radiologist or surgeon) following each procedure. The survey will include the
NASA Task Load Index (TLX) to assess the work load associated with the procedure as well as
several questions designed to determine if the NASA TLX score would likely have been higher
or lower if the augmented reality system was not used and several questions designed to
determine if the augmented reality system allowed visualization of imaging information in a
way that was helpful in procedure planning or intraprocedural approach. The NASA TLX method
assesses work load on five 7-point scales and the additional questions assess procedural
strain on 7-point scales.

The primary outcome measures are the TLX scores. If these scores achieve statistical
significance in one sample statistical tests then use of the augmented reality display will
be considered successful. Although co-investigators will be subjects, the co-investigators
have no relationship with the device maker and have no invested interest in using this device
unless the device improves procedure efficiency and success; as such, it is unlikely that
co-investigators as subjects will bias the results as the co-investigators will not want to
utilize the device if it has a negative impact on workflow or if it increases perceived work
load.

Inclusion Criteria:

- Any patient referred to one of the study co-investigators for a procedure that
requires either: Pre-procedure planning that utilizes either CT or MR images;
Intra-procedure imaging for the purpose of needle placement.

Exclusion Criteria:

- Age under 18 at time of procedure.