Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Completed; Phase 3

Conditions: Radiation Protection; Radiation Monitoring

Treatments: Device: Radiation monitoring device

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01510353

11-097

Details and patient eligibility

About

The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing clinically-indicated cardiac catheterization

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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505 participants in 2 patient groups

Use of a radiation monitoring device

Experimental group

Description:

Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization

Treatment:

Device: Radiation monitoring device

No use of radiation monitoring device

No Intervention group

Description:

No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization