Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

Not Applicable

Completed

• Conditions: Patients Undergoing Invasive Cardiac Procedures; Radiation Exposure
• Interventions: Device: Novel Lead Based Armboard; Device: Standard Armboard

• Registration Number: NCT03605030
• Lead Sponsor: London Health Sciences Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-29
• Primary Completion: 2018-01-25
• Study Completion: 2018-05-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-21
• Study First Submitted QC: 2018-07-21
• Last Update Submitted: 2018-07-21
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel Lead Based Armboard	Novel Lead Based Armboard	-
Standard Armboard	Standard Armboard	-

Primary Outcome Measures

Name	Time	Method
Radiation dose (μSv) to the operator at the forearm level	At procedure completion	Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
Radiation dose (μSv) to the operator at the chest	At procedure completion	Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

Secondary Outcome Measures

Name	Time	Method
Dose area product	At procedure completion
Air kerma	At procedure completion
Radiation dose to the patient	At procedure completion

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada