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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01510353
First received: January 9, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Radiation Monitoring
Radiation Protection
Device: Radiation monitoring device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Radiation exposure of the operator [ Time Frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour ] [ Designated as safety issue: Yes ]
    Radiation exposure of the operator (measured in mrem by the real time monitoring device)


Secondary Outcome Measures:
  • Radiation exposure of the patient [ Time Frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour ] [ Designated as safety issue: Yes ]
    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


Enrollment: 505
Study Start Date: January 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of a radiation monitoring device
Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization
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
No Intervention: No use of radiation monitoring device
No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510353

Locations
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Study Chair: Emmanouil S. Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01510353     History of Changes
Other Study ID Numbers: 11-097
Study First Received: January 9, 2012
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on July 23, 2014