Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04774588 |
| Other study ID # |
REB21-0111 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
April 1, 2022 |
Study information
| Verified date |
February 2021 |
| Source |
University of Calgary |
| Contact |
Darshan Dr Bakshi, MD |
| Phone |
4039919257 |
| Email |
dbakshi[@]ucalgary.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objectives:
Primary
- Evaluate the primary operator usability of VSI streaming software for realtime streaming
of images from video capture devices to a head mounted display (Hololens 2) during
Interventional Radiology procedures Secondary
- Evaluate Radiographer usability of VSI streaming software.
- Develop suggestions for future research studies to assess the safety and efficacy of the
VSI streamer software during other Interventional radiology procedures
- Evaluate the impact of VSI streaming software on room setup time, procedural time and
fluoroscopy time
- Assess the feasability of remote collaboration by real time image transmission between
remote devices through 3D telemedicine
Description:
The ergonomic design and setup of an operating/procedure room have long been a studied topic
of interest. Back in 1999, an article (1) reviewed the ongoing research into the effects that
operator posture, the operating room environment, and visualization of screens have on the
ergonomics of surgery. They made the observation that 'future efforts to create a more user-
friendly operating room environment will require the rethinking of traditional concepts of
architecture, asepsis, and staffing (1). As technology rapidly advances, we are increasingly
able to reassess and enhance the current ergonomic structure and setup of operating rooms and
procedures.
Interventional radiology (IR) refers to a variety of minimally invasive procedures using
small- caliber catheters under fluoroscopic or ultrasound guidance for the treatment of
vascular and urologic, gastrointestinal conditions without the need for open surgery (2).
Interventional Radiology has the unique ergonomic consideration of the placement of the
intraoperative viewing monitors (3). To perform any Interventional Radiology procedure,
radiologists currently use a ceiling mounted or floor mounted image intensifier, a ceiling
mounted screen and a small floor mounted monitor. In many procedures (usually those requiring
downstream access into the vessel, arm or neck vascular access) the Radiologist has to move
their own position to visualize all the screens, as it is impossible to rotate the screens
adequately so that they are in a direct line with the Radiologists vision. Previous studies
of office video terminal display (VDT) users demonstrate that the preferred viewing angle for
VDTs is between 10° to 25° below the line of sight(4). The monitors are placed in such a way
that the Interventional radiologist cannot possibly maintain the correct line of sight
without some neck movement and craning. Inevitably, long periods of time standing in this
awkward position can lead to musculoskeletal issues for the radiologist, as well as the
stress of performing a procedure safely without the best line of vision.
The Interventional Radiologist is also wearing a heavy lead apron during the procedure, which
adds to the ergonomic challenges. The incidence of neck and back pain increases with hours of
apron use and years of practice, and may be the result of a combination of axial load (ie,
prolonged standing in protective garments), awkward or poor posture (necessitated by leaning
or bending to accomplish procedures), and repetitive injury accumulated over years of
practice. (5)
In addition, there are multiple other screens monitoring patient parameters which are outside
of the Interventional radiologist's field of view during the procedure, creating further
safety concerns. Of note, other current concerns in the Interventional suite are costly
screen breakage during manoeuvre of the screens during suite setup, and sterility issues that
arise when the monitor is brought too close to the operating field.
The intention is that the new device will project a hologram of all the screens which can be
positioned exactly in front of the operator at all times, irrespective of the patient
position. Because it is mixed reality, the operator can still see their surroundings and
perform the procedure exactly as normal.
With this technology, multiple screens of different modalities can be added, such as CT
scans, MRI scans and 3D rendered holograms. Specific device instructions can also be
visualized if necessary, without the requirement for the radiologist to leave the sterile
procedure site.
The device can also be used to stream fluoroscopic and 3D images to a remote hololens or
computer screen. This can be utilized for remote assistance and mentoring purposes. It will
also be especially useful in the context of COVID-19, where reducing the clinical exposure of
health care workers is of vital importance.
The main intention of the pilot study is to assess whether the hypothesis that the VSI
streamer and HMD will indeed improve the ergonomics of the interventional suite sufficiently
enough that the Interventional radiologist can perform the procedures more comfortably and
safely. The practicalities of adding the VSI Streamer and HMD to the interventional suite
setup will also be assessed.
During this initial pilot study, a practical assessment will be performed of the usability of
the VSI streamer during commonly performed elective angiographic procedures. This will
identify which procedures are particularly suited to this technology.
