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

Radiation Protection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510353
• Other study ID #: 11-097
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2012
• Last updated: July 2, 2014
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Radiation Monitoring
• Radiation Protection

Intervention

Device:
• Radiation monitoring device
Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization

Locations

Country	Name	City	State
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation exposure of the operator	Radiation exposure of the operator (measured in mrem by the real time monitoring device)	radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour	Yes
Secondary	Radiation exposure of the patient	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	radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour	Yes