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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01510353
Enrollment
505
Registered
2012-01-16
Start date
2012-01-31
Completion date
2014-05-31
Last updated
2014-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Monitoring, Radiation Protection

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.

Interventions

DEVICERadiation monitoring device

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

Sponsors

North Texas Veterans Healthcare System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing clinically-indicated cardiac catheterization

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Radiation exposure of the operatorradiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hourRadiation exposure of the operator (measured in mrem by the real time monitoring device)

Secondary

MeasureTime frameDescription
Radiation exposure of the patientradiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hourRadiation 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026