Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

Radiation Exposure Clinical Trial

— RADAR  

Official title:

Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605030
• Other study ID #: 108913
• Status: Completed
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: July 2018
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 30, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

Exclusion Criteria:

• Inability to provide consent

Related Conditions & MeSH terms

• Patients Undergoing Invasive Cardiac Procedures
• Radiation Exposure

Intervention

Device:
• Novel Lead Based Armboard
Novel Lead Based Armboard
• Standard Armboard
Standard Armboard (without lead)

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
London Health Sciences Centre	Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation dose (µSv) to the operator at the chest	Co-primary outcomes included radiation dose (µSv; mean ± SD) to the operator at the chest and forearm level.	At procedure completion
Primary	Radiation dose (µSv) to the operator at the forearm level	Co-primary outcomes included radiation dose (µSv; mean ± SD) to the operator at the chest and forearm level.	At procedure completion
Secondary	Air kerma		At procedure completion
Secondary	Dose area product		At procedure completion
Secondary	Radiation dose to the patient		At procedure completion