Novel Wireless Mixed Reality Headset for Image Guidance in Cardiac Catheterization Laboratory (MRCCL)

SG Devices

Status: Unknown

Conditions: Radiation Injuries

Treatments: Device: Mixed reality heads up display

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05063773

HUD_002

Details and patient eligibility

About

Our hypothesis is that improved line of sight to patient data, ergonomics, and headset lead shielding in the CCL will lead to behavioral changes in the CCL personnel that will reduce radiation exposure to all members of the team. Further, reducing the burden of large, cumbersome monitors will enable improved use of shielding. Our approach is a single center randomized controlled trial of consecutive patients randomly assigned to one of two groups with group 1 using mixed reality display and group 2 using standard 2D displays to perform diagnostic angiography in the CCL. Radiation exposure will be evaluated at multiple levels including total radiation exposure, exposure of each individual staff member, as well as specific exposure to eyes and head in group 1 versus group 2.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing diagnostic coronary angiography

Exclusion criteria

• acute coronary syndrome, cardiogenic shock, cardiac arrest, planned intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Device: Mixed reality heads up display

Group 2

No Intervention group