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

Phase 3

Completed

• Conditions: Radiation Monitoring; Radiation Protection
• Interventions: Device: Radiation monitoring device

• Registration Number: NCT01510353
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

• Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Radiation exposure of the operator	radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour	Radiation exposure of the operator (measured in mrem by the real time monitoring device)

Secondary Outcome Measures

Name	Time	Method
Radiation exposure of the patient	radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour	Radiation exposure of the patient, as measured by the X-ray machine using (a) air kerma dose, (b) dose area product, (c) fluoroscopy and cineangiography time

Trial Locations

Locations (1)

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States