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OpenTrials
Completed

NCT Number: NCT01510353

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

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.

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Key information

Conditions

Radiation Monitoring Radiation Protection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing clinically-indicated cardiac catheterization

Exclusion criteria

  • None

Treatment and study plan

Radiation monitoring device

Device

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

Primary outcomes

  1. 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

    Radiation exposure of the operator (measured in mrem by the real time monitoring device)

Secondary outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2012
Registry last updated
Jul 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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