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

Not Applicable

• Conditions: Radiation Injuries
• Interventions: Device: Mixed reality heads up display

• Registration Number: NCT05063773
• Lead Sponsor: SG Devices LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01
• Study Start: 2023-03
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• undergoing diagnostic coronary angiography

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Mixed reality heads up display	-

Primary Outcome Measures

Name	Time	Method
Radiation exposure to the physician	up to 24 months

Secondary Outcome Measures

Name	Time	Method
radiation exposure to the patient and medical staff	up to 24 months