Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board

NCT02088788 | Completed Results

• 1 other identifier: 2013-0140
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation exposure to operator is an occupational hazard of invasive cardiologists. During radial access for diagnostic catheterization, a new radio-dense arm board is advertised to reduce operator radiation exposure. The investigators randomize patients to a new radio-dense armboard versus a standard radio-transparent armboard during diagnostic catheterization and measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in place. The investigators hypothesize that operator radiation dose will be decreased by use of the radio-dense armboard.

Conditions

Radiation Exposure to Operator

Keywords

radiation; radiation injury; occupational risk

Outcome Measures

Primary Outcomes (1)

• Operator Radiation Exposure

  mSieverts radiation dose to the operator during diagnostic catheterization

  during initial diagnostic catheterization procedure, an average of 30 minutes

Secondary Outcomes (1)

• Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography

  During procedure, an average of 35 minutes

Study Arms (2)

Board (Rad Board")

EXPERIMENTAL

Radial artery catheterization is performed using radio-opaque armboard

Device: Board

No Board

ACTIVE COMPARATOR

Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield

Device: No Board

Interventions

Board DEVICE

Also has radio-dense pelvic shielding

Also known as: "Rad Board"

Board (Rad Board")

No Board DEVICE

Radio-lucent armboard for radial access with radio-dense drape across pelvis

No Board

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Operators: Interventional or diagnostic interventional attendings and fellows, operators willing to participate.
• Patients: Age 18-89 years old requiring catheterization at Geisinger Medical Center using radial access

You may not qualify if:

• patients with CABG, requiring extensive imaging, with operator switch during the procedure
• patients in whom the procedure took unusual time because of anatomic issues, and need to switch to alternative access.

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Limitations and Caveats

We excluded post hoc procedures that required prolonged imaging. This resulted in unequal sizes of the board and no-board groups. As a single-center trial, results may not be generalizable to cath labs with different radiation protection set-ups.

Results Point of Contact

• Title: Melissa Troup
• Organization: Geisinger

matroup@geisinger.edu

570-214-5433

Study Officials

• James C Blankenship, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 24, 2018
• Results First Posted: October 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)