Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774588
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-02-08
Brief Title:
HoloStream Study - Video Capture Device Usage
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Holographic Streaming of Input From Video Capture Devices During Interventional Radiology Procedures - a Feasibility Study Hololens Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Holo-Stream
Brief 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
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
Detailed Description:
The ergonomic design and setup of an operatingprocedure 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 sight4 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 radiologists 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
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 sight4 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 radiologists 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None