Radiation Exposure to OperatorNCT02088788
Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board
A study testing Board and No Board in people with Radiation Exposure to Operator, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Radiation Exposure to Operator
- What is being tested?
- Board and No Board
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board
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.
Read the detailed description
Hypothesis:
Compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board in addition to the pelvic drape will decrease operator radiation exposure during radial access cardiac catheterization by at least 30%.
STUDY DESIGN This is a randomized, prospective study where patients will be randomized by random numbers in sealed envelopes to standard shielding (pelvic drape alone, the "no-board group") or to experimental shielding (pelvic drape plus radiation board, the "board group").
A robust radiation safety monitoring program is in place. Patient exposure is measured by the catheterization laboratory equipment and recorded. Lindauer Microstar Nanodot badges worn at waist level above the radiation lead will be used to measure operator radiation exposure. A new Nanodot will be used for every case. Radiation exposure to the operator's Nanodot will be measured immediately after each procedure by a technician blinded to study assignment.
All patients 18-89 years old presenting to Geisinger Medical Center for diagnostic cardiac catheterization will be evaluated for the study. All interventional or diagnostic cardiologists and fellows that will be performing the cardiac catheterization procedure also will be study subjects. Approximately 215 Geisinger patients who satisfy inclusion and exclusion criteria will be included. Approximately 6 interventional cardiologists, 2 diagnostic cardiologists and 10 fellows will be included in this study.
- Conditions
- Radiation Exposure to Operator
- Being tested
- Board, No Board
- Keywords
- radiation, radiation injury, occupational risk
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoardDevice
Also called "Rad Board"
Also has radio-dense pelvic shielding
No BoardDevice
Radio-lucent armboard for radial access with radio-dense drape across pelvis
| Study group | Role | What they receive |
|---|---|---|
| Board (Rad Board") | Experimental | Radial artery catheterization is performed using radio-opaque armboard Receives: 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 Receives: Device: No Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator Radiation Exposure
mSieverts radiation dose to the operator during diagnostic catheterization
Measured: 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
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.
Measured: During procedure, an average of 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiation Exposure to OperatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James C. Blankenship, Geisinger Clinic
- Investigators
- James C Blankenship, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088788
- Sponsor's protocol ID
- 2013-0140
- Status last verified
- Sep 2018
- First submitted
- 13 Mar 2014
- Last updated
- 24 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board
- ClinicalTrials.gov ID
- NCT02088788
- Acronym / sponsor ID
- 2013-0140
- Conditions
- Radiation Exposure to Operator
- Keywords
- radiation, radiation injury, occupational risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis:
Compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board in addition to the pelvic drape will decrease operator radiation exposure during radial access cardiac catheterization by at least 30%.
STUDY DESIGN This is a randomized, prospective study where patients will be randomized by random numbers in sealed envelopes to standard shielding (pelvic drape alone, the "no-board group") or to experimental shielding (pelvic drape plus radiation board, the "board group").
A robust radiation safety monitoring program is in place. Patient exposure is measured by the catheterization laboratory equipment and recorded. Lindauer Microstar Nanodot badges worn at waist level above the radiation lead will be used to measure operator radiation exposure. A new Nanodot will be used for every case. Radiation exposure to the operator's Nanodot will be measured immediately after each procedure by a technician blinded to study assignment.
All patients 18-89 years old presenting to Geisinger Medical Center for diagnostic cardiac catheterization will be evaluated for the study. All interventional or diagnostic cardiologists and fellows that will be performing the cardiac catheterization procedure also will be study subjects. Approximately 215 Geisinger patients who satisfy inclusion and exclusion criteria will be included. Approximately 6 interventional cardiologists, 2 diagnostic cardiologists and 10 fellows will be included in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Board (Rad Board") | Experimental | Device: BoardRadial artery catheterization is performed using radio-opaque armboard |
| No Board | Active comparator | Device: No BoardRegular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoardAlso: "Rad Board"Also has radio-dense pelvic shielding | Device | Board (Rad Board") |
| No BoardRadio-lucent armboard for radial access with radio-dense drape across pelvis | Device | No Board |
Primary outcome
Operator Radiation Exposure
Time frame: during initial diagnostic catheterization procedure, an average of 30 minutes
mSieverts radiation dose to the operator during diagnostic catheterization
1 secondary outcome
Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography
Time frame: During procedure, an average of 35 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Radiation Exposure to Operator
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Recruiting
Exoskeleton vs. Standard Lead Apron in EVAR Procedures
Radiation Exposure to Operator, Endovascular Aortic Repair
Recruiting
Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access
Radiation Exposure
Active, not recruiting
Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)
Occupational Radiation Exposure in Interventional Cardiology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Blankenship, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Board and No Board in people with Radiation Exposure to Operator, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator Radiation Exposure (time frame: during initial diagnostic catheterization procedure, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.