Trial Outcomes & Findings for Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board (NCT NCT02088788)

Results Overview

mSieverts radiation dose to the operator during diagnostic catheterization

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

265 participants

Primary outcome timeframe

during initial diagnostic catheterization procedure, an average of 30 minutes

Results posted on

2018-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Board (Rad Board") Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding	No Board Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis
Overall Study STARTED	135	130
Overall Study COMPLETED	105	89
Overall Study NOT COMPLETED	30	41

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Board (Rad Board") n=105 Participants Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding	No Board n=89 Participants Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis	Total n=194 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 12.1 • n=105 Participants	64.2 years STANDARD_DEVIATION 9.5 • n=89 Participants	64.5 years STANDARD_DEVIATION 10.94 • n=194 Participants
Sex: Female, Male Female	37 Participants n=105 Participants	38 Participants n=89 Participants	75 Participants n=194 Participants
Sex: Female, Male Male	68 Participants n=105 Participants	51 Participants n=89 Participants	119 Participants n=194 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: during initial diagnostic catheterization procedure, an average of 30 minutes

mSieverts radiation dose to the operator during diagnostic catheterization

Outcome measures

Outcome measures
Measure	Board (Rad Board") n=105 Participants Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding	No Board n=89 Participants Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis
Operator Radiation Exposure	.65 mSv Interval 0.57 to 0.78	.56 mSv Interval 0.48 to 0.63

SECONDARY outcome

Timeframe: During procedure, an average of 35 minutes

mSieverts radiation dose to the operator during diagnostic catheterization with versus without ventriculography/aortography. This outcome measure includes 2 types of procedures: diagnostic catheterization plus LV gram and diagnostic catheterization plus aortography. Ventriculography is defined as injection through a pigtail catheter into the left ventricle using a power injector. Aortography is defined as injection through a pigtail catheter into the aorta using a power injector.

Outcome measures

Outcome measures
Measure	Board (Rad Board") n=105 Participants Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding	No Board n=89 Participants Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis
Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography With Ventriculogram/aortogram	.65 mSv Interval 0.55 to 0.78	.61 mSv Interval 0.5 to 0.66
Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography Without ventriculogram/aortogram	.66 mSv Interval 0.58 to 0.79	.54 mSv Interval 0.48 to 0.61

Adverse Events

Board (Rad Board")

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Board

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Troup

Geisinger

Phone: 570-214-5433

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place