The purpose of this study is to determine whether the ControlRad system device when installed in Fluoroscopic (x-ray) machine reduces radiation dose to operators (Doctors and nurses) and to the patient who is undergoing cardiac Catheterization and electrophysiology (EP) implant procedures.
This is a Prospective, randomized (like a "flip of a coin") single center study evaluating the ControlRad system device when installed - retrofitted on existing C-arms for fluoroscopy (x-ray) will reduce radiation exposure without compromising image quality in the region of interest and overall workflow during cardiac catheterization and electrophysiology (EP) implant procedures. Enrollment will be limited to 40 cardiac catheterization, and 30 pacemaker and/or ICD procedures. All patients presenting to Beaumont Hospital Royal Oak who are scheduled for cardiac catheterization with coronary angiography and electrophysiology implant in Cath Lab 5 where device is installed will be considered for inclusion in the study. Physicians and staff (20 fellows; 35 attending physicians; and 56 Cath-lab staff,including Nurse/Anesthesia team) will be invited to participate in the study. For each procedure, 3 staff members will be study subjects: a) the primary operator, b) the secondary operator, c) the nurse/tech and or Anesthetist who circulates in the room. Different operators and staff may participate in each case depending on cath-lab scheduling. The Primary operator is the physician who usually stands nearest to the C-arm. In most cases in Beaumont this is a Cardiology Fellow in cardiac catheterization cases and Attending Physician for the EP cases. The Secondary operator is the physician who typically stands to the right of the primary operator and in most cases is the attending cardiologist or scrub assistant (nurse/technician). The Nurse or Anesthesia team typically circulates in the room and is responsible for monitoring the patient, administering medications and obtaining equipment for the procedure. Two methods will be used to measure radiation dose during the catheterization procedure. The Real-time Dosimeter Badge (RaySafe) and the Landauer Luxel Aluminium Oxide Dosimeter Badges. Cardiac Catheterization and electrophysiology implant procedures will be performed according to standard guidelines. Participants will be randomized 1:1 to either cardiac catheterization without ControlRad or cardiac catheterization with the ControlRad system. The same 1:1 randomization process will be applied to the EP patient population. Participants will be blinded to the randomization. Once procedure is done,participation also ended and the badges will be removed by the Radiation Safety Officer or research coordinator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
170
Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Radiation Dose to Primary Operator (RaySafe), Cardiac Catheterization
Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Primary Operator (Luxel Dosimeter), Cardiac Catheterization
Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Primary Operator, EP Procedure (Luxel)
Mean effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure. A single Luxel dosimeter was and a cumulative dose was recorded.
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Primary Operator, EP Procedure (RaySafe)
Median effective radiation dose in microsievert (μSv) to the primary operator at the end of each EP implant procedure using a RaySafe dosimeter. This is measured after each case.
Time frame: During each EP implant procedure, an average of 90 minutes duration
Radiation Dose to Secondary Operator, Cardiac Catheterization (RaySafe)
Median effective radiation dose (μSv) to the secondary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
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Radiation Dose to Secondary Operator (Luxel Dosimeter), Cardiac Catheterization
Mean effective radiation dose in microsievert (μSv) to the secondary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (RaySafe)
Median effective radiation dose in microsievert (μSv) to the Nurse 0r Anesthetist at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, Cardiac Catheterization (Luxel)
Mean effective radiation dose in microsievert (μSv) to the Nurse or Anesthetist at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Patient, Cardiac Catheterization
Median radiation dose-area product (DAP) to the patient at the end of each cardiac catheterization case using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated micro-gray μGy\*m\^2.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose in Cath Lab Room #5, Cardiac Catheterization
Mean radiation dose microsieverts (μSv) at the end of each cardiac catheterization case at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each cardiac catheterization, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (RaySafe)
Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Secondary Operator, EP Procedure (Luxel)
Mean effective radiation dose (μSv) to the secondary operator at the at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (RaySafe)
Median effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a RaySafe dosimeter to assess the radiation dose in each case.
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Nurse or Anesthetist, EP Procedure (Luxel)
Mean effective radiation dose in microsievert (μSv) to the primary operator at the thyroid. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes
Radiation Dose to Patient, EP Procedure
Mean radiation dose-area product (DAP) to the patient at the end of each EP implant procedure using data from a fluoroscopy machine. DAP is defined as the absorbed dose multiplied by the area irradiated (μGy\*m\^2)
Time frame: During each EP implant procedure, an average of 30-45 minutes of active radiation
Radiation Dose in Cath Lab Room #5, EP Procedure
Mean radiation dose (μSv) at the end of each EP implant procedure at a standard location on the wall of the catheterization laboratory. This was measured using a single Luxel dosimeter over all cases to assess the cumulative dose in the study arm.
Time frame: During each EP implant procedure, an average of 90 minutes